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PURPOSE: To evaluate the long-term outcomes of uveitic macular edema DESIGN: Longitudinal follow-up of a cohort of participants in a randomized clinical trial PARTICIPANTS: 248 eyes of 177 participants with uveitic macular edema enrolled in the Multicenter Uveitis Steroid Treatment Trial and Follow-up Study METHODS: Optical coherence tomography (OCT) measurements, taken at baseline and annually, were graded by reading-center graders masked to clinical data. Macular edema was defined as a center point macular thickness (CMT) ≥240 μm on time-domain OCT or time-domain OCT equivalent. Resolution of macular edema was defined as normalization of macular thickness on OCT. Relapse of macular edema was defined as increase in macular thickness to ≥240 μm in an eye that previously had resolution. Visual acuity was measured at each visit with logarithmic visual acuity charts. MAIN OUTCOME MEASURES: Resolution and relapse of macular edema. Visual acuity. RESULTS: Among 227 eyes with macular edema followed ≥1 year, the cumulative percent of eyes with macular edema resolving at any point during 7 years was 94% (95% confidence interval [CI]: 89%, 97%). Epiretinal membranes on OCT were associated with a lower likelihood of macular edema resolution (hazard ratio [HR] 0.74; 95% CI 0.55, 1.01; P=0.05). Among 177 eyes with resolved macular edema, the cumulative percent with relapse within 7 years was 43% (95% CI: 32%, 51%). Eyes in which macular edema resolved gained a mean of 6.24 letters (95% CI: 4.40, 8.09, P< 0.001) compared to eyes that remained free from macular edema during the 1-year follow-up intervals, whereas eyes where macular edema did not resolve experienced no gain in vision (mean change −1.30 letters; 95% CI: −2.70, 0.09, P=0.065), and eyes that developed macular edema during the year (either incident or relapsed) experienced a mean loss of −8.65 letters (95% CI: −11.5, −5.84, P< 0.001). CONCLUSIONS: Given sufficient time and treatment, nearly all uveitic macular edema resolves, but episodes of relapse were common. Visual acuity results were better among eyes with resolved macular edema, suggesting that control of inflammation and resolution of macular edema might be visually-relevant treatment targets.

Ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution seems to be efficacious and safe in treating acute otitis externa (AOE) compared with ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solution alone.To evaluate the superiority of ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution compared with ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solution alone in treating AOE.A phase 3 randomized, double-blind, active-controlled clinical trial was conducted between August 1, 2017, and September 14, 2018, at 36 centers in the US. The study population comprised 493 patients aged 6 months or older with AOE of less than 21 days' duration with otorrhea, moderate or severe otalgia, and edema, as well as a Brighton grading of II or III (tympanic membrane obscure but without systemic illness). Statistical analysis was performed from November 14, 2018, to February 14, 2019.Participants were randomly assigned to receive ciprofloxacin plus fluocinolone, ciprofloxacin, or fluocinolone twice daily for 7 days and were evaluated on day 1 (visit 1; baseline), days 3 to 4 (visit 2; conducted via telephone), days 8 to 10 (visit 3; end of treatment), and days 15 to 17 (visit 4; test of cure).The primary outcome was therapeutic cure (clinical and microbiological) at the end of the treatment period. The principal secondary end point was the time to end of ear pain. Efficacy analyses were conducted in the microbiological intent-to-treat population, clinical intent-to-treat population, and microbiological intent-to-treat population with Pseudomonas aeruginosa and Staphylococcus aureus.A total of 493 patients (254 female patients [51.5%]; mean [SD] age, 38.2 [23.1] years) were randomized (197 to receive ciprofloxacin plus fluocinolone, 196 to receive ciprofloxacin, and 100 to receive fluocinolone). Therapeutic cure in the modified intent-to-treat population with ciprofloxacin plus fluocinolone (63 of 103 [61.2%]) was statistically comparable to that of ciprofloxacin (49 of 91 [53.8%]; difference in response rate, 7.3%; 95% CI, -6.6% to 21.2%; P = .30) and fluocinolone (20 of 45 [44.4%]; difference in response rate, 16.7%; 95% CI, -0.6% to 34.0%; P = .06) at visit 3 and significantly superior to ciprofloxacin at visit 4 (90 of 103 [87.4%] vs 69 of 91 [75.8%]; difference in response rate, 11.6%; 95% CI, 0.7%-22.4%; P = .04). A statistically faster resolution of otalgia was achieved among patients treated with ciprofloxacin plus fluocinolone (median, 5.0 days [range, 4.2-6.3 days]) vs ciprofloxacin (median, 5.9 days [range, 4.3-7.3 days]; 95% CI, 4.3-7.3 days; P = .002) or fluocinolone (median, 7.7 days [range, 6.7-9.0 days]; 95% CI, 6.7-9.0 days; P .001). Ciprofloxacin plus fluocinolone demonstrated statistical superiority in sustained microbiological response vs ciprofloxacin (94 of 103 [91.3%] vs 74 of 91 [81.3%]; difference in response rate, 9.9%; 95% CI, 0.3%-19.6%; P = .04) and fluocinolone (34 of 45 [75.6%]; difference in response rate, 15.7%; 95% CI, 2.0%-29.4%; P = .01) and in the microbiological outcome vs fluocinolone by visit 3 (99 of 103 [96.1%] vs 37 of 45 [82.2%]; difference in response rate, 13.9%; 95% CI, 2.1%-25.7%; P = .01) and ciprofloxacin by visit 4 (97 of 103 [94.2%] vs 77 of 91 [84.6%]; difference in response rate, 9.6%; 95% CI, 0.9%-18.2%; P = .02). Fifteen adverse events related to study medications were registered, all of which were mild or moderate.Ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution was efficacious and safe in treating AOE but did not demonstrate superiority vs ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solutions alone in the main study end point of therapeutic cure.ClinicalTrials.gov Identifier: NCT03196973.

Submitted by Maria da Luz Antunes (mluz.antunes@estesl.ipl.pt) on 2021-02-12T17:21:16Z No. of bitstreams: 1 Dril influences short-term visual outcome after intravitreal corticosteroid injection for refractory diabetic macular edema.pdf: 1929585 bytes, checksum: b122842dfb7a55c7ed74e0c1718b6363 (MD5) Made available in DSpace on 2021-02-12T17:21:16Z (GMT). No. of bitstreams: 1 Dril influences short-term visual outcome after intravitreal corticosteroid injection for refractory diabetic macular edema.pdf: 1929585 bytes, checksum: b122842dfb7a55c7ed74e0c1718b6363 (MD5) Previous issue date: 2021-01 info:eu-repo/semantics/publishedVersion

PURPOSE: To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, “implant”) therapy. DESIGN: Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort METHODS: Patients with intermediate, posterior or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome. RESULTS: Among 405 uveitic at-risk eyes of 232 patients (median follow-up=6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant upon implantation) developed glaucoma (Hazard Ratio (HR)=5.9 (95% CI: 3.2, 10.8); p

BackgroundThe 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, ‘real-world’ safety results for the FAc implant in DMO.MethodsThis 24-month interim analysis of a prospective, observational study investigated patients with DMO receiving the commercially available intravitreal 0.2 µg/day FAc implant. The primary outcome was incidence of intraocular pressure (IOP)-lowering procedures. Other IOP-related signals and their relationship to previous corticosteroid exposure, best-corrected visual acuity, central subfield thickness (CST), ocular adverse events and frequency of other treatments were also measured.ResultsData were collected from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant. Mean IOP for the overall population remained stable post-FAc compared with pre-FAc implant. IOP-related procedures remained infrequent (two IOP-lowering surgeries pre-FAc; two trabeculoplasties and four IOP-lowering surgeries post-FAc). Mean visual acuity was stable post-FAc (mean improvement of 1–3 letters) and fewer DMO treatments were required per year following FAc implant. Mean CST was significantly reduced at 24 months post-FAc implant (pConclusionFew IOP-related procedures were reported during the 24 months post-FAc implant. Positive efficacy outcomes were noted after treatment, with stabilisation of vision and reduction in inflammation, demonstrated by CST. The FAc implant has a favourable benefit–risk profile in the management of DMO, especially when administered after a prior steroid challenge.Trial registration numberNCT02424019.

BACKGROUND AND OBJECTIVE: Assess fluocinolone acetonide implant (FAc) effects on diabetic macular edema (DME) retinal thickness fluctuations. PATIENTS AND METHODS: A post-hoc chart review of the real-world USER study analyzed patients receiving 0.2 μg/day FAc implant. The percentage of eyes with central subfield thickness (CST) of 300 µm or less were compared pre- and post-FAc implant; mean retinal thickness amplitude (RTA), retinal thickness standard deviation (RTSD), and two case studies were analyzed. RESULTS: One hundred thirty patients (mean age: 69.6 years) presented; CST was available for 120 of 160 treated eyes. Mean RTA decreased significantly post-FAc implant ( P < .001) regardless of baseline visual acuity (VA). Correlations with last-observed VA (R 2 ) were: RTA, 0.1197; retinal thickness standard deviation (RTSD), 0.1526; and area under the CST-time curve (AUC CST), 0.0981. After FAc implant, the percentage of eyes with CST of 300 μm or less was significantly greater versus baseline ( P < .05). CONCLUSIONS: Retinal thickness fluctuations significantly declined after FAc and correlated with improvement in VA. Both RTSD and RTA measures correlated more closely to last observed VA than AUC CST itself. [ Ophthalmic Surg Lasers Imaging Retina . 2020;51:298–306.]

Objectives: To evaluate central foveal thickness (CFT) variability and accompanying changes in visual acuity (VA) 12 months before and after treatment with the 190 mcg fluocinolone acetonide (FAc) ...

Melasma is a common, acquired, circumscribed hypermelanosis of sun-exposed skin. It presents as symmetric, hyperpigmented macules having irregular, serrated, and geographic borders. Compare the efficacy of 35% gycolic acid (GA) peel vs. Jessner peel (JP) as an adjuvant to topical triple combination (2% Hydroquinone, 0.025% tretinoin, 0.01% Fluocinolone acetonide) therapy in Melasma in females. Sixty cases of Melasma attending Skin-VD OPD, Baroda Medical College from September 1, 2016 to July 30,/2017 were enrolled. Among them, 12% cases had history of menstrual irregularity, 5% cases had past history of oral contraceptive (OC) pill intake, and 10% cases had history of working outdoors. Most common pattern of melasma was centrofacial 32 cases (53%) which was followed by malar pattern in 27 cases (47%) and mandibular pattern in one case (2%). Fifty cases who completed study were evaluated for comparative efficacy of GA peel versus JP as an adjuvant to topical triple combination therapy. Average reduction in Melasma Area and Severity Index (MASI) score in cases treated with GA peel group was 58.56% with Jessner peel group was 59.12%. In GA peel group, 84% cases had moderate to good improvement, whereas in JP group 92% cases had moderate to good improvement. According to present study, safety and efficacy profile of 35% GA peel vs. JP was almost same. Both can be used as an adjuvant to topical triple combination therapy of 2% hydroquinone, 0.025% tretinoin, and 0.01% fluocinolone acetonide in females suffering from melasma. We recommend that it will be safer for the pregnant women to get the GA peel rather than the treatment containing hydroquinone and tretinoin since the activity/performance is very similar.

Melasma is a common malady affecting all races with a higher incidence in Hispanics, Middle Eastern, Asians, and African origin females (Fitzpatrick skin phototypes III-V). Women are affected much more often than men. Melasma remains a significant cause of cosmetic morbidity and psychosocial embarrassment affecting quality of life necessitating effective and reliable treatment. Unfortunately, treatment remains unsatisfactory due to limited efficacy, adverse effects, and relapses after stopping treatment. Although chemical peels, laser and light therapies and dermabrasion may have utility, the evidence available for their efficacy is limited and they often cause post-inflammatory hyperpigmentation, particularly in individuals with darker skin types. Medical therapies remain mainstay in the management of melasma. The triple combination, hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01% (Triluma, Galderma, Ft. Worth Texas, often modified incorporating different corticosteroids) remains the only US FDA-approved treatment for melasma and is the gold standard due its demonstrated efficacy across ethnicities. Oral tranexamic acid alone or in combination with other modalities has also shown significant efficacy. Several cosmeceuticals and botanical extracts used as skin lightening agents have been demonstrated to be useful. Physical sunscreens containing zinc oxide, iron oxide, titanium dioxide, and silicones provide photoprotective and camouflage effect. We propose that a multimodality approach to the treatment of melasma is the most effective treatment approach. This review is focused on the medical therapies for melasma.

Background: First-line treatment for diabetic macular edema (DME) is usually with antivascular endothelial growth factor agents, followed by intravitreal corticosteroids as a second-line treatment option. Long-term corticosteroids may offer quality of life and effectiveness benefits over short-term implants. Objectives: To evaluate outcomes of patients with persistent or recurrent DME who switched from a short-term (dexamethasone) to a long-term (fluocinolone acetonide, FAc) corticosteroid intravitreal implant in a real-world setting. Methods: This is a retrospective study in 9 Portuguese centers. An FAc intravitreal implant was administered according to product labeling. Effectiveness outcomes were mean change in visual acuity (VA; ETDRS letters), central retinal thickness (CRT; µm), and macular volume (MV; mm3). The safety outcome was mean change in intraocular pressure (IOP; mm Hg). All were analyzed at months 1 and 3, and then quarterly until month 24 after implantation. Results: Forty-four eyes from 36 patients were analyzed. Mean duration of DME was 3.3 ± 1.9 years, and mean follow-up was 8 months. From baseline following FAc implantation, VA increased significantly at months 1 and 6 (mean +6.82 and +13.02 letters, respectively; p = 0.005), and last observation carried forward (LOCF; mean +8.3 letters; p = 0.002). CRT improved significantly at months 1 and 6 (mean –71.81 and –170.77 µm, respectively; p = 0.001), and LOCF (mean –121.46 µm; p = 0.001). MV was consistently, but not significantly, decreased from baseline to LOCF (mean –0.69 mm3; p = 0.062). The mean change in IOP was –0.25 and +0.88 mm Hg at months 1 and 6, respectively (p = 0.268), and +1.86 mm Hg at LOCF (p = 0.036). Increases were controlled with topical medication in most cases. Conclusions: The FAc intravitreal implant is effective in patients previously treated with short-term corticosteroid implants. Thus, after a suboptimal response to antiangiogenics or a short-term corticosteroid, a single FAc implant may be considered an effective and tolerable treatment that can improve long-term outcomes for patients with sight-threatening DME.

Aims Fluocinolone acetonide (FAc) is an intravitreal corticosteroid implant approved for the second-line treatment of diabetic macular edema (DME). This study compared outcomes of patients with DME switched directly to an FAc implant, versus indirectly via dexamethasone, after anti-VEGF therapy failure. Methods This is a retrospective, single-center chart review. Patients were assigned to Group A (switched to FAc after anti-VEGF) or Group B (switched to dexamethasone and then to FAc after > 4 months). Charts were reviewed for best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) and cataract development. Results Forty-nine eyes were included. BCVA increased and CMT decreased with anti-VEGF (both groups), and dexamethasone (Group B only), but regressed after stopping treatment. With FAc, BCVA increased rapidly and significantly: increases were maintained up to 36 months (P P 21 mmHg occurred in 14 patients (nine in Group A, five in Group B): all were sufficiently treated with IOP-lowering drops. Nineteen phakic eyes (73.1%) developed cataract: seven underwent phaco-emulsification (two in Group A, five in Group B). Conclusions Similar functional and anatomical improvements occurred in FAc-treated eyes, regardless of whether they first received dexamethasone or switched directly to FAc after anti-VEGF. Safety signals were consistent with corticosteroid class effects. Early switch to FAc could benefit patients who respond insufficiently to anti-VEGF.

Melasma is an acquired cutaneous disorder characterized by hyperpigmentation of the face predominantly affecting the areas exposed to direct sun light. The triple combination cream, i.e., a mid-potency corticosteroid (Fluocinolone acetonide 0.01%), a retinoid (Tretinoin 0.05%), and Hydroquinone 4% is one of the widely used topical medicament for melasma treatment world over. Tranexamic acid is another agent found to be effective in melasma treatment when used topically, intra-lesionally or orally. This study has been conducted to compare mean decrease in Melasma Area Severity Index (MASI) score when tranexamic acid is combined with triple combination cream versus triple combination cream alone for melasma treatment.A randomized controlled trial was conducted in a tertiary care hospital of Pakistan. Sixty-three patients of melasma who met the inclusion criteria and gave written informed consent for the study were enrolled. These patients were randomly divided into 2 treatment groups. Group A was given triple combination cream and oral tranxemic acid while Group B was given triple combination cream for duration of 8 weeks. Severity of melasma was assessed by MASI, which was calculated at baseline and at the end of week 8. Mean decrease in MASI score was calculated in both groups and statistically analysed employing SPSS 20.Sixty patients, 30 in both groups, completed the study. Study participants were predominantly female (81.67%), with mean age of 30.46±6.24 years in group A while 31.90±4.53 in group B. No statistically significant difference was noted in both treatment groups for mean decrease in the MASI score (6.4933±4.38358 in group A compared to 5.7833±5.04251 in the group B; p-value 0.56).The addition of oral tranexamic acid did not contribute significantly in decrease in MASI score when used in combination with topical triple regimen. It may have a role as an adjuvant to topical triple combination cream.

In eyes with uveitis and a history of fluocinolone acetonide (FA) implantation, glaucoma drainage implants (GDIs) provides excellent long-term control of intraocular pressure (IOP).The purpose of this study was to evaluate the long-term control of IOP achieved by GDIs in uveitic eyes with glaucoma and a FA implant.Retrospective case series of 56 eyes from 37 patients with a history of noninfectious posterior uveitis who underwent both FA implantation and GDI surgery at the Cleveland Clinic Cole Eye Institute between April 2001 and April 2017. Patients were excluded if they did not undergo FA implantation before, or concurrently with, a GDI. Data was collected up to 10 years after GDI surgery. Outcome measures included IOP, number of IOP-lowering medications, and surgical success rate at each timepoint. Success was defined as IOP between 6 and 21 mm Hg at the most recent follow-up visit, without need for GDI removal or additional IOP-lowering surgeries, or loss of light perception.The mean follow-up time was 71.0 months (median 72.0 mo). IOP was reduced by a mean of 52.9% (range: 43.1% to 62.3%) and the number of IOP-lowering medications decreased by a mean of 69.0% (range: 56.3% to 93.8%) between 1 and 10 years postoperatively. The percentage of eyes with IOP21 mm Hg was 32.1% at baseline and ranged between 76.8% and 100% at follow-up. The percentage of eyes with IOP18 mm Hg was 21.4% at baseline and ranged between 67.9% and 100% at follow-up. The surgical success rate was 71.4% at 10 years.In eyes with uveitis that undergo FA implantation, concurrent or subsequent GDI surgery offers excellent long-term control of IOP. Postoperative IOP and number of IOP-lowering medications dropped considerably and remained stable.

BACKGROUND/PURPOSE To report a case of dislodgement of an Iluvien (fluocinolone acetonide) intravitreal implant into the infusion cannula during pars plana vitrectomy for retinal detachment. METHODS The patient's surgery was video recorded, and the medical notes were reviewed retrospectively. RESULTS A patient developed a macula off retinal detachment over 1 year after intravitreal injection of Iluvien for diabetic maculopathy. The patient underwent pars plana vitrectomy, removal of implant, and successful retinal reattachment. Although we planned to remove the implant through a sclerostomy, we were not able to localize it after performing peripheral indented vitrectomy. As the intraocular pressure was fluctuating, we suspected that the implant might have dislodged into the infusion cannula. However, despite increasing the intraocular pressure to 60 mmHg and performing repeated fluid-air exchange, we could not eject the implant back into the vitreous cavity. Therefore, after completing the surgery safely, we flushed the infusion cannula with balanced salt solution and we found the implant. CONCLUSION Increasing the intraocular pressure and performing fluid-air exchange were not sufficient to eject the implant probably because of the strong surface adherence between the infusion cannula and the implant's coating material. We, therefore, recommend removing and flushing the infusion cannula if the implant cannot be localized in the eye. In addition, clinicians should be aware that a fluctuating intraocular pressure might be the first sign of a partially blocked infusion cannula by the implant.

AimsThe ILUVIEN Registry Safety Study is an ongoing, multicentre, open-label, observational study collecting real-world data on the safety and effectiveness of the 0.2 µg/day fluocinolone acetonide (FAc) implant in patients treated according to the European label requirements.MethodsPatients included in this analysis were treated for the licensed indication of chronic diabetic macular oedema (cDMO; that is, DMO that persists or recurs despite treatment). Data presented in the current analysis were collected from patient records up to 6 March 2017. Visual acuity (VA) data, including mean change in VA over time and at last observation, intraocular pressure (IOP) over the course of the study, IOP events, use of IOP-lowering therapy and cup:disc ratio were analysed. Information on additional DMO treatments post-FAc implant was also captured.ResultsFive hundred and sixty-three patients (593 eyes) were enrolled on the study. Mean IOP for the overall population remained within the normal range throughout follow-up and 76.7% of patients did not require IOP-lowering therapy following treatment with the FAc implant. Sixty-nine per cent of eyes did not require additional DMO treatments. Mean VA in the overall population increased from 51.9 letters at baseline to 55.6 letters at month 12, with a significant increase of 2.9 letters at last observation. Patients with short-term cDMO experienced greater VA gains than those with long-term cDMO.ConclusionsThe results of this analysis are comparable with those of other studies, including the Fluocinolone Acetate for Macular Edema study. The study reinforces the good safety and effectiveness profile of FAc, and demonstrates the benefit of early FAc treatment.

BACKGROUND AND OBJECTIVE: Visual outcomes of the FAME study (0.2 μg/day fluocinolone acetonide [FAc]) and Protocol I (0.5 mg ranibizumab plus deferred laser) were compared using the area under the curve (AUC) analysis method. PATIENTS AND METHODS: Best-corrected visual acuity (BCVA) data collected during a period of 3 years of follow-up for patients enrolled in FAME or Protocol I were used to calculate AUC of the change in BCVA over a time curve. RESULTS: In the overall population, there was a greater treatment effect for ranibizumab plus deferred laser compared with FAc. However, for subgroups of pseudophakic eyes, eyes with chronic diabetic macular edema (DME), and pseudophakic eyes with chronic DME, ranibizumab plus deferred laser and FAc were not found to be significantly different. The ranibizumab group received a median of 14 injections during a 36-month period compared with a mean of 1.3 injections in the FAc group. CONCLUSION: In pseudophakic and chronic DME subgroups, FAc was comparable to ranibizumab plus deferred laser with fewer injections. [ Ophthalmic Surg Lasers Imaging Retina . 2018;49:698–706.]

BACKGROUND AND OBJECTIVE: To report on the use of intravitreal steroids in the management of acute zonal occult outer retinopathy (AZOOR), a rare disorder affecting the outer retina. PATIENTS AND METHODS: Retrospective case series of nine eyes of five patients with AZOOR who received intravitreal triamcinolone acetonide (IVTA), dexamethasone intravitreal implant, and/or fluocinolone acetonide implant. Treatment response was determined by reported symptoms and multimodal imaging findings. Patients were observed for at least 1 year following intravitreal steroid treatment (range: 14 months to 63 months). RESULTS: Seven eyes received IVTA, six eyes received the dexamethasone intravitreal implant, and one eye received the fluocinolone acetonide implant. All patients experienced disease stability or improvement based on symptomatic response and multimodal imaging findings after intravitreal steroids. One eye developed central serous retinopathy, and another eye a choroidal neovascular membrane. Five of nine eyes experienced ocular hypertension. All phakic eyes developed cataracts. CONCLUSION: Intravitreal steroids effectively achieved disease stability in patients with AZOOR. [ Ophthalmic Surg Lasers Imaging Retina . 2018;49:504–509.]

Background Melasma is an acquired, facial hyperpigmentation without a specific origin. It is regularly associated with multiple etiologic factors such as pregnancy, genetic, racial, and from estrogen administration. Among the methods to treat skin hyperpigmentation a series of skin bleaching agents have been used. At present, the most commonly used agent is known as hydroquinone. Nowadays, it is known that hydroquinone can cause cancer in animals with unknown relevance to humans. Material and methods In this work, Raman spectroscopy was used to observe the presence of hydroquinone in the skin of 18 patients who have been under treatment for melasma. Results A significant increase in the Raman signal was observed in the six bands associated with hydroquinone after melasma treatment. Conclusion The authors believe that monitoring the presence of hydroquinone may be useful for an optimal personalized treatment of melasma and to provide the specialist a support tool to control the administration of this type of bleaching agents.

Aims To compare safety outcomes and visual function data acquired in the real-world setting with FAME study results in eyes treated with 0.2 μg/day fluocinolone acetonide (FAc). Methods Fourteen UK clinical sites contributed to pseudoanonymised data collected using the same electronic medical record system. Data pertaining to eyes treated with FAc implant for diabetic macular oedema (DMO) was extracted. Intraocular pressure (IOP)-related adverse events were defined as use of IOP-lowering medication, any rise in IOP>30 mm Hg, or glaucoma surgery. Other measured outcomes included visual acuity, central subfield thickness (CSFT) changes and use of concomitant medications. Results In total, 345 eyes had a mean follow-up of 428 days. Overall, 13.9% of patients required IOP-lowering drops (included initiation, addition and switching of current drops), 7.2% had IOP elevation >30 mm Hg and 0.3% required glaucoma surgery. In patients with prior steroid exposure and no prior IOP-related event, there were no new IOP-related events. In patients without prior steroid use and without prior IOP-related events, 10.3% of eyes required IOP-lowering medication and 4.3% exhibited IOP >30 mm Hg at some point during follow-up. At 24 months, mean best-recorded visual acuity increased from 51.9 to 57.2 letters and 20.8% achieved ≥15-letter improvement. Mean CSFT reduced from 451.2 to 355.5 μm. Conclusions While overall IOP-related emergent events were observed in similar frequency to FAME, no adverse events were seen in the subgroup with prior steroid exposure and no prior IOP events. Efficacy findings confirm that the FAc implant is a useful treatment option for chronic DMO.

To investigate the effects of fluocinolone acetonide (FAc) on the progression to proliferative diabetic retinopathy (PDR) and the impact of FAc on changes in Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy (DR) severity scale (DRSS) grade during the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) A and B Phase III clinical trials.Post hoc analysis of data from the 36-month prospective, randomized, FAME A and B trials.Patients with diabetic macular edema (DME) who received sham control or FAc 0.2 or 0.5 μg/day.A masked reading center (University of Wisconsin-Madison) determined DRSS grade and retinal perfusion status using standard 7-field stereo fundus photography and fluorescein angiography, respectively. Retinopathy changes over time were determined by DRSS step differences from baseline to month 36. Pairwise comparisons between the 3 treatment groups were performed using a log-rank test without adjustment for covariates, with the primary comparison between sham control and 0.2 μg/day FAc.Study eye progression to PDR based on a composite clinical outcome of (1) progression from nonproliferative diabetic retinopathy (NPDR) to PDR based on graded fundus photographs, (2) panretinal photocoagulation (PRP), or (3) pars plana vitrectomy (PPV) for PDR; and study eye changes on the DRSS.In the integrated FAME data set, compared with sham control-treated subjects, time to first PDR event was significantly delayed in subjects treated with FAc (P0.001), and this effect was confirmed in subgroups with more severe DR and chronic DME at baseline. In addition, subjects with retinal nonperfusion at baseline showed greater reduction in progression to PDR with FAc treatment. Both FAc dosages demonstrated statistically significant improvements in mean DR severity compared with sham treatment at months 6, 12, and 18. Numerically more subjects who received FAc experienced 2-or-more- or 3-or-more-step improvements in DR severity compared with subjects who received sham; conversely, fewer subjects treated with FAc experienced 2-or-more- or 3-or-more-step worsening in DR severity. The 3-or-more-step improvement with 0.5 μg/day FAc was statistically significantly different from sham control.In subjects with DME, sustained intraocular delivery of FAc slows development of PDR and slows progression of diabetic retinopathy.

Chronic macular oedema is a well-known presentation of radiation-induced maculopathy (RM) following external beam photon therapy, plaque radiotherapy and proton beam radiotherapy for choroidal tumours. Current therapies vary in respect of efficacy and clinical benefit. The potential of fluocinolone acetonide (FAc) slow-release implants is unknown. We hypothesised that local continuous delivery of low-dose corticosteroids might improve symptoms of RM. Five—two male and three female—patients from 37 to 68 years presented with RM following 106Ru-plaque brachytherapy or stereotactic radiation therapy (STx) with photons using a hypofractionated schedule of 5 × 10 Gy. All were treated with triamcinolone injections in first line and proofed to be refractory to steroids. In addition, two patients had received Ozurdex® implants as a second-line treatment, though without any clinical benefit. FAc slow-release implants were injected, and patients were followed up to monitor clinical improvement. All patients responded to therapy by means of a decrease in macular oedema. In four of five (80%) patients, visual acuity improved, and one patient showed stable visual acuity. No toxic effects or complications were observed. Slow-release implants of FAc are a promising therapeutic potent steroid treatment option to benefit anatomical structures of the fovea and visual function. Slow-release implants with FAc reduce the frequency of intravitreal injections and the therapeutic burden.

A 42-year-old woman with phototype V, presented a 9-year history of refractory centrofacial melasma to topical bleaching agents and peelings, untreated for the last 90 days. One session of microneedling with 1.5 mm needles was performed with hydroquinone 4% sterile serum drug delivery; after 3 days, modified Kligman's formula (hydroquinone 4% + fluocinolone acetonide 0.01% + tretinoin 0.05%) and broad-spectrum sunscreen SPF 70 were introduced for daily use. After 30 days, a significant improvement was observed in the clinical outcome (Figure 1) and the quality of life of the patient. These parameters were measured using Melasma Area and Severity Index (MASI) scale, with an 82.5% decrease, and Melasma Quality of Life Scale - Brazilian Population (MELASQoL-BP), with a 60% decrease. Dermatoscopic analysis (polarized videodermatoscopy x20) of the glabellar region revealed lighting of the pseudoreticular pigment network, diffuse light to dark brown background, and reduction in vascularity and telangiectasias (Figure 2). At the 5-month follow-up, there had been no relapse. The patient continued to use a broad-spectrum sunscreen along with the topical regiment.

Objective: To evaluate, in the setting of persistent diabetic macular edema, the impact that continuous fluocinolone acetonide delivery has on treatment burden, visual acuity, central retinal thickness, and intraocular pressure. Materials and methods: A single-center, retrospective, cohort study of patients with persistent diabetic macular edema, previously treated with anti–vascular endothelial growth factor injections, dexamethasone implants, or focal laser, who were subsequently treated with fluocinolone acetonide was conducted. All retinal visits were analyzed prior to fluocinolone acetonide, until the most recent follow-up visit. Primary outcomes were pre– and post–fluocinolone acetonide changes in the best-corrected visual acuity and number of treatments required for diabetic macular edema. Secondary outcomes included changes in the central retinal thickness and intraocular pressure. Results: A total of 19 eyes with persistent diabetic macular edema were included and followed for a mean (SD) of 399.3 (222.9) days. Post–fluocinolone acetonide, the mean best-corrected visual acuity improved by 0.4 ETDRS letters for all eyes ( p = 0.895) and the central retinal thickness decreased by 34.2 µm ( p = 0.077). After fluocinolone acetonide, the number of treatments decreased from an average of one treatment every 2.7 months to one every 6 months ( p = 0.009). Furthermore, post–fluocinolone acetonide, 10/19 eyes (52.6%) did not require additional treatment due to a dry macula, and those who did experienced a non-statistically significant reduction of treatments, from one every 2.6 months pre–fluocinolone acetonide, to one every 2.8 months post–fluocinolone acetonide ( p = 0.622). Conclusions: In the setting of persistent diabetic macular edema, fluocinolone acetonide significantly reduces the therapeutic burden, while maintaining best-corrected visual acuity and improving the central retinal thickness. In patient-centered discussions, judiciously employing fluocinolone acetonide should be performed to mitigate this therapeutic burden for patients.

The purpose of this study is to report the long-term efficacy and safety of 0.19 mg fluocinolone acetonide intravitreal implant (ILUVIENThis is a single-centre retrospective analysis of patients with persistent diabetic macular oedema, despite previous anti-vascular endothelial growth factor and/or steroid treatment, treated with the ILUVIEN implant according to national guidelines. Patients with follow-up of less than 24 months were excluded. Best corrected visual acuity, central retinal thickness and intraocular pressure were evaluated at baseline and month 3, 12, 24 and 36 post-treatment. A sub-group analysis was performed on eyes with 36-month follow-up data.In total, 24 eyes (24 patients) completed at least 24 months of follow-up, of which 9 completed 36 months of follow-up. Three-fourths of the patients were black or South Asian (blacks, Asians and minority ethnic). Improvement in mean best corrected visual acuity was seen at year 1 and year 3 improving from 0.62 LogMAR at baseline to 0.55 LogMAR at year 1 and 0.47 LogMAR at year 3 (all p 0.05). Mean central retinal thickness also showed a progressive reduction from 471 μm at baseline to 397 μm at year 1 and 339 μm at year 3 (all p 0.05). Four eyes required intraocular pressure-lowering drops post-implant. Supplementary treatment for persistent or recurrent diabetic macular oedema was necessary in 13 eyes over the total study period of 3 years. Blacks, Asians and minority ethnic patients had a worse response compared with white patients.The ILUVIEN implant was effective and safe in the treatment of multi-ethnic patients with diabetic macular oedema refractory to conventional therapies, improving the vision and macular anatomy, without significant adverse events up to 36 months post-treatment.

Purpose: To investigate baseline characteristics of patients undergoing additional antivascular endothelial growth factor (VEGF) injections for residual or recurrent diabetic macular edema (DME) in the first year after 0.19-mg fluocinolone acetonide (FAc) implant. Design: Prospective cohort study. Methods: Ninety-four eyes of 66 patients received an FAc implant. Eyes with persistent or recurrent DME were managed with pro re nata anti-VEGF agents. Demographic data and medical history were collected at baseline. Best-corrected visual acuity and central macular thickness were measured every 2 months. The 3 outcomes explored were 1) the risk factors for administration of additional anti-VEGF agents, 2) the interval from FAc to first anti-VEGF injection; and 3) the number of anti-VEGF doses required to maintain regression of DME. Results: Eighteen eyes (19.1%) of 13 patients received 1.3 ± 0.6 anti-VEGF injections. These eyes had significantly thicker central macular thickness at baseline and over the entire follow-up period (P < .001); best-corrected visual acuity was similar at every time point to eyes that were not receiving extra DME treatments. Eyes without preexistent panretinal photocoagulation (PRP) had a higher risk to undergo supplemental treatments (hazard ratio 1.5 [95% confidence interval 1.1-2.5, P = .03). The interval between FAc implant and the first anti-VEGF had a significant linear positive relationship with the number of dexamethasone implants before FAc implant (P = .002, R2 = 0.47). No association was found between baseline factors and the number of injections given. Conclusion: Anti-VEGF agents are efficient treatment to maintain visual acuity in residual/recurrent DME after FAc. Patients with higher baseline central macular thickness and with no previous central macular thickness are more likely to require additional treatments to control DME.

To determine the time to disease recurrence with long-acting injectable fluocinolone acetonide implant (FAi) for noninfectious intermediate, posterior, and panuveitis. This was a retrospective study of patients with at least 12 months of follow-up who had completed a 2-year prospective, investigational new drug study with 0.18-mg FAi. Time to uveitis recurrence or cystoid macular edema (CME) occurrence was recorded. Twelve eyes from 12 participants (mean age 43 years, range 25–64 years) were included. Patients were followed for a mean of 34.2 months (range, 12.0–56.9 months) after completion of the prospective trial. Five eyes (42%) did not have a documented uveitis recurrence or CME occurrence. Five eyes (42%) had a uveitis recurrence with the mean time to recurrence 36.1 months (range, 22.8–61.1 months) after FAi implantation. Two eyes (16%) had CME alone, the mean time to occurrence 36.9 months (range 36.1–42.1 months). On Kaplan-Meier analysis, the estimated probability of remaining recurrence-free 36 months after FAi implantation was 0.67 (95% confidence interval, 0.34–0.86). Data of study participants after completing a clinical trial suggest that the injectable FAi for noninfectious uveitis can provide control for 3 years on average. These long-term data support the use of FAi to control noninfectious uveitis.

To examine the 36-month efficacy and safety of a 0.2 μg/day fluocinolone acetonide insert (FAi) to treat noninfectious uveitis of the posterior segment (NIU-PS).Phase 3, prospective, double-masked, multicenter study (clinicaltrials.gov, NCT01694186).Adults (≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids.Participants were randomized 2:1 to FAi or sham (injection plus standard of care) treatment.The primary outcome was the difference between the proportion of FAi-treated and sham-treated patients who had a uveitis recurrence. Secondary outcomes included time to first recurrence, number of recurrences, best-corrected visual acuity (BCVA) change from baseline, resolution of macular edema, and number of adjunctive treatments.One hundred twenty-nine participants (n = 87 FAi-treated; n = 42 sham-treated) were enrolled. Over 36 months of treatment, cumulative uveitis recurrences were significantly reduced with FAi compared with sham (65.5% vs. 97.6%, respectively; P0.001); time to first recurrence was commensurately longer (median 657.0 and 70.5 days, respectively; P0.001). The number of recurrences per eye was significantly lower in the FAi-treated compared with the sham-treated group (mean 1.7 vs. 5.3, respectively, P0.001). At 36 months, more FAi-treated eyes had a ≥15-letter increase in BCVA from baseline and fewer FAi-treated eyes had investigator-determined macular edema at month 36 compared with sham-treated eyes (33.3% vs. 14.7% and 13.0% vs. 27.3% for BCVA and macular edema, respectively). Fewer FAi compared with sham-treated participants required adjunctive treatments (57.5% vs. 97.6%, respectively). Intraocular pressure (IOP) was similar for both study groups at month 36 (mean ± standard deviation 14.5±5.1 and 14.8±5.3, respectively), and approximately half as many eyes in the FAi-treated group when compared with the sham-treated group underwent IOP-lowering surgery (5.7% vs. 11.9%). Cataract surgery was required more frequently over 36 months in the FAi-treated compared with the sham-treated group (73.8% vs. 23.8% of eyes, respectively).Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.

We report two pediatric patients with a history of chronic lichenified atopic dermatitis (AD) who subsequently developed eruptive lentigines at sites of resolved AD. The occurrence of this phenomenon in eczematous dermatoses in the absence of topical calcineurin inhibitor (TCI) use is rarely reported in the literature.

To determine factors conferring an increased risk of developing ocular hypertension secondary to the fluocinolone acetonide (FA) sustained-release surgical implant (Retisert).Retrospective, observational case series.Patients with a history of chronic noninfectious posterior uveitis undergoing naïve surgical FA implantation from 2007 to 2018 at the University of Colorado were studied. Patient demographics and multiple clinical measures were noted one year before and after FA implantation.Twenty-nine eyes of 21 patients were studied. The median age experiencing an IOP rise vs median age experiencing no IOP rise post-FA implantation was 27.0 and 54.0 years old, respectively (A

Purpose There is no prevention or treatment for diabetic retinal neurodegeneration (DRN), which is a complication of diabetes that can occur independently of diabetic retinopathy (DR). We hypothesized that an intravitreal fluocinolone acetonide (FAc) implant may affect the rate of DRN when used in patients with diabetic macular edema (DME). Methods In this retrospective analysis, optical coherence tomography with neuroretinal analysis was obtained at 3-month intervals from 130 patients in the USER study both before (mean duration 903 days, range 35-4005 days) and after administration of FAc (mean 408 days, range 7 to 756 days). The rate of DRN was defined as the change over time on inner neuroretinal thickness using logistic regression. A DRN rate was calculated independently for two areas: region 1 located within 1.5 mm of the fovea, and region 2 from 1.5 mm to 3.0 mm from the fovea. Results In regions of the macula more than 1.5 mm from the central fovea, there was a statistically significant decrease in the rate of DRN in the post-FAc period. The pre-FAc neuroretinal loss in this area occurred at 4.0 μm/y, compared with a post-FAc loss rate of 1.1 μm/y (P = 0.001). Conclusions This retrospective study suggests that FAc may decelerate the rate of inner retinal thinning in patients with persistent DME. Further prospective studies are necessary to determine the effects of FAc on the rate of DRN in patients with DME.

BACKGROUND Recent evidence suggests melasma to be a photoaging disorder. Triple combination creams (TCC: fluocinolone acetonide 0.01%, hydroquinone 4% and tretinoin 0.05%) remain the gold standard treatment. Picosecond alexandrite laser treatment using a diffractive lens array (DLA) has been identified to be effective for improving photoaging conditions. OBJECTIVE We aimed to compare the efficacy and tolerance of the picosecond alexandrite laser with those of DLA and TCC in female Asian patients with melasma. METHODS Twenty-nine patients were randomly assigned to group A1 (3 laser sessions at 4-week intervals), A2 (5 laser sessions at 4-week intervals) or B (TCC daily for at least 8 weeks and then tapered until the final evaluation). The Melasma Area, Severity Index (MASI) score and VISIA were assessed at baseline, week 12 and week 20. By week 20, the follow-up periods for groups A1 and A2 were 3 months and 1 month, respectively. RESULTS Nine, 11 and 6 participants in groups A1, A2 and B completed the study, respectively. MASI scores were significantly improved in all 3 groups at weeks 12 and 20. In groups A1, A2 and B, the improvement rates at week 20 were 53%, 38% and 50%, respectively. VISIA® analysis additionally revealed a significant improvement in spots, porphyria, pores and brown spots after 3 laser sessions (P

Ozurdex is a dexamethasone intravitreal implant used for the treatment of macular oedema. A rare but serious complication is the migration of the implant into the anterior chamber (AC) in eyes with absent or incomplete posterior capsules that may lead to corneal decompensation. We report the case of a 75-year-old woman who presented with a 1-day history of decreased vision in her left eye. She had a history of complicated cataract surgery and had received multiple Ozurdex implants for postoperative cystoid macular oedema in the same eye. She had significant left corneal decompensation and a mobile Ozurdex implant in the AC. We report a simple but novel surgical technique for removing an Ozurdex implant from the AC using an intravenous cannula (Venflon). This technique can also be applied to removing a fluocinolone acetonide (Iluvien) implant in similar situations.

Purpose Limited data are available on the efficacy of the 0.2 μg/day fluocinolone acetonide (FAc) implant in eyes with prior vitrectomy. Here, we present a collection of 26 vitrectomized eyes treated with the 0.2 μg/day FAc implant. Methods Retrospective study involving six centers from four European countries analyzing the safety and efficacy data from patients (26 eyes from 25 patients) with DME and a prior vitrectomy that had been treated with one 0.2 μg/day FAc implant. Results Prior intravitreal therapies included anti-VEGF (mean, 3.8 injections) and steroids (mean, 1.9 injections). Pars plana vitrectomy (PPV) was performed in these eyes primarily for abnormalities of vitreoretinal interface, followed by proliferative diabetic retinopathy and vitreous hemorrhage. The 0.2 μg/day FAc implant was injected 24.2 months, on average, after PPV and the mean duration of follow-up after injection was 255 days (range, 90 to 759 days). The mean change in BCVA was +11.7 ETDRS letters (range, −19 to +40 letters; P

Purpose To report the 12-months visual and anatomical outcomes of chronic diabetic macular oedema (DMO) treated with ILUVIEN in a real-world clinical practice in a single tertiary referral centre. Method Retrospective data collection and analysis of consecutive 28 eyes of 23 diabetic patients received ILUVIEN implant for refractory DMO. Standard assessment included visual acuity (VA), central retinal thickness (CRT), slit-lamp biomicroscopy, and Goldmann tonometry for intraocular pressure (IOP) at 1, 6, and 12 months. Results Baseline mean VA was 47 (SD 18) letters improved to 55 (SD 17) letters (P=0.004) at 12 months. VA was improved in 16 eyes (57%), stabilised in 9 eyes (32%), and decreased in 3 eyes (11%). Seven eyes (25%) gained ≥15 letters, and 10 eyes (36%) gained >10 letters from baseline. The percentage of eyes achieved driving vision (≥70 Early Treatment Diabetic Retinopathy Study letters) was doubled from baseline 18 to 36% at 6 months and 32% at 12 months. Mean CRT decreased by 198 μm from baseline 494 μm (SD 191) to 296 μm (SD 121) at 12 months (P

PURPOSE To investigate the efficacy and safety of fluocinolone acetonide intravitreal implant in patients with Vogt-Koyanagi-Harada disease. METHODS A post hoc, subgroup analysis on patients with Vogt-Koyanagi-Harada was performed using data sets from two multicenter randomized trials on fluocinolone acetonide implant. Each subject received fluocinolone acetonide implantation in one eye and standard-of-care treatment in the fellow eye and was followed for 3 years. RESULTS Thirty patients were included with the mean age of 38.5 years. The cumulative rate of uveitis recurrence for 3 years was significantly reduced in implanted eyes compared with fellow eyes (33 vs. 87%; P < 0.001). The reduction of daily corticosteroid dose was well maintained (12.8 mg before implantation vs. 3.7 mg after implantation; P = 0.001), but final vision was similar to preoperative vision in the implanted eyes (P = 0.082) and in the fellow eyes (P = 0.187). Postoperative elevation of intraocular pressure was more frequent in the implanted eyes than in the fellow eyes (70 vs. 20%; P < 0.001). Cataract progression occurred in all phakic implanted eyes. CONCLUSION Fluocinolone acetonide intravitreal implant reduced uveitis recurrence rate and the dosage of systemic corticosteroid and immunosuppressant requirement in patients with Vogt-Koyanagi-Harada. However, cataract and intraocular pressure elevation developed frequently.

Paclitaxel (PTX) is among the most commonly used cancer drugs that cause chemotherapy-induced peripheral neuropathy (CIPN), a debilitating and serious dose-limiting side effect. Currently, no drugs exist to prevent CIPN, and symptomatic therapy is often ineffective. In order to identify therapeutic candidates to prevent axonal degeneration induced by PTX, we carried out a phenotypic drug screening using primary rodent dorsal root ganglion sensory neurons. We identified fluocinolone acetonide as a neuroprotective compound and verified it through secondary screens. Furthermore, we showed its efficacy in a mouse model of PTX-induced peripheral neuropathy and confirmed with four different cancer cell lines that fluocinolone acetonide does not interfere with PTX's antitumor activity. Our study identifies fluocinolone acetonide as a potential therapy to prevent CIPN caused by PTX.

IMPORTANCE: Melanoma-associated retinopathy (MAR) is a paraneoplastic syndrome in which antiretinal antibodies crossreact with retinal ON-bipolar cells, resulting in night blindness and progressive visual field loss. Current therapeutic options include cytoreductive surgery in combination with immunoglobulin, corticosteroids, or plasmapheresis, but their effectiveness is limited and may be contraindicated, given the possible protective role of circulating autoantibodies against metastatic spread. We report 3-year follow-up of the first case (to our knowledge) of MAR treated with intravitreal long-acting steroid implants. OBJECTIVE: To report on a patient with MAR who was treated with intravitreal fluocinolone acetonide implants in the absence of systemic immunosuppression. DESIGN, SETTING, AND PARTICIPANTS: This is a 3-year follow-up of a 73-year-old woman with a history of surgical excision of a malignant melanoma of the left pinna who presented with visual symptoms of shimmering and nyctalopia. Fundus examination, fundus autofluorescence, and optical coherence tomography were normal, with no evidence of cystoid macular edema. Automated perimetry showed a reduction in visual field and full-field electroretinography (ERG) demonstrated findings consistent with generalized ON-bipolar cell dysfunction, typical of MAR. The patient was treated with bilateral fluocinolone acetonide intravitreal implants. MAIN OUTCOMES AND MEASURES: Visual acuity, visual field, and electroretinography testing for 3 years after treatment. RESULTS: Visual fields improved in this 73-year-old patient from 20/30 (Snellen measured as 6/9) OD and 20/16 (6/5) OS at baseline to 20/20 OU within 1 week of treatment. Detailed electroretinography monitoring indicated characteristic abnormalities that partly resolved after treatment, consistent with improved inner retinal ON-bipolar cell function. Bilateral cataracts developed approximately 2 years after injection; cataract surgery was performed uneventfully. At 3 years posttreatment, the patient remained visually stable and in systemic disease remission, with best-corrected visual acuity remaining at 20/20 OU. CONCLUSIONS AND RELEVANCE: We report what is, to our knowledge, the first case of MAR treated with intravitreal slow-release corticosteroid implants, which shows improvements in visual symptoms, visual fields, and retinal function. Sustained-release intraocular steroid implants may offer an effective and safe alternative to systemic immunosuppression in MAR, although results from 1 case should be generalized with abundant caution.

Introduction: The Retro-IDEAL (ILUVIEN Implant for chronic DiabEtic MAcuLar edema) study is a retrospective study designed to assess real-world outcomes achieved with the ILUVIEN® (0.19 mg fluocinolone acetonide (FAc)) in patients with chronic diabetic macular edema (DME) in clinical practices in Germany. Methods: This study was conducted across 16 sites in Germany and involved 81 eyes (63 patients) with persistent or recurrent DME and a prior suboptimal response to a first-line intravitreal therapy (primarily anti-VEGF intravitreal therapies). Results: Patients were followed-up for 30.8 ± 11.3 months (mean ± standard deviation) and had a mean age of 68.0 ± 10.4 years. Best-recorded visual acuity (BRVA) improved by +5.5 letters at month 9 (P ⩽ 0.005, n=56; from a baseline of 49 letters) and this was maintained through to month 30 (P ⩽ 0.05, n = 42). There was a concurrent improvement in central macular thickness with a reduction from 502 µm at baseline to 338 µm at year 1 (P ⩽ 0.0001, n = 43). This effect was sustained to year 3 (i.e. 318 µm; P ⩽ 0.0001, n = 29). Mean intraocular pressure (IOP) remained constant between baseline and year 3 with a peak change of 1.9 mm Hg occurring at year 1. Elevated IOP was observed in a similar percentage of patients prior to (22.2% of cases) and following (27.2%) treatment with the FAc implant. In the majority of cases, these elevations were managed effectively with IOP medications. Conclusions: Despite substantial amounts of prior intravitreal treatments – primarily with anti–vascular endothelial growth factor (VEGF) drugs – this real-world study showed that sustained structural and functional improvements can last for up to 3 years with a single FAc implant.

Background In this report, we present the results of a severe case of Sjögren’s syndrome-related keratopathy after fluocinolone acetonide 190-μg intravitreal implant (Iluvien®; Alimera Sciences Inc.) therapy. Case presentation A 52-year-old Caucasian woman with Sjögren’s syndrome secondary to autoimmune hepatitis and primary sclerosing cholangitis was admitted to our emergency department owing to bilateral corneal ulcers and corneal perforation in the left eye following exposure keratopathy in an artificially induced coma. Within the following months, recurrent fulminant keratolysis with perforations required multiple penetrating keratoplasties and amniotic membrane transplants in both eyes. With new signs of severe keratolysis, an intravitreal fluocinolone acetonide implant was injected off-label in the left eye, and a third penetrating keratoplasty was performed 2 weeks later. In the 6 months of follow-up after the last penetrating keratoplasty, no more surgical interventions were needed in the eye with the fluocinolone acetonide implant. The corneal surface remained stable, and intraocular pressure was normal. During this time frame, two further penetrating keratoplasties, one vitrectomy, and five amniotic membrane transplants were performed in the fellow eye owing to relapsing keratolysis and perforations. Conclusions To the best of our knowledge, this is the first report of fluocinolone acetonide intravitreal therapy in a patient with corneal disease. In the 6-month follow-up period, no surgical intervention was needed in the eye with the fluocinolone acetonide implant, whereas further penetrating keratoplasties and amniotic membrane transplants were performed in the fellow eye. Intravitreal fluocinolone acetonide may be considered as a treatment option in severe cases of autoimmune corneal disease.

Objectives: To assess the efficacy and safety of fluocinolone acetonide 0.025% otic solution versus placebo in treating patients with otic eczema. Methods: In this multicentre, randomized, double-blind, parallel-group phase 3 clinical trial, conducted at 12 Spanish centres between March 2012 and March 2013, patients received fluocinolone acetonide 0.025% or placebo otic solution twice daily for 7 days (days 1-7) with an 8-day follow-up (days 9-15). Outcome measures included change in itching from baseline (day 1) to study days 4-8 and 9-15, and change in otoscopic signs (erythema, oedema, and scaling) from baseline to the end of treatment (day 8) and end of follow-up (day 15). Results: Patients treated with fluocinolone acetonide 0.025% (n = 66), as compared with place-bo-treated patients (n = 69), showed significantly higher reductions in itching from baseline to study days 4-8 and 9-15, and in individual and global otoscopic signs from baseline to the end of treatment (day 8) and end of follow-up (day 15). Incidence and severity of adverse events was similar between the fluocinolone and placebo groups. Conclusions: Fluocinolone acetonide 0.025% otic solution, administered twice daily for 7 days, is an effective and safe treatment for otic eczema., This report represents the results of the clinical trial sponsored by Laboratorios Salvat, S.A. as part of the Spanish AEMPS approval of the fluocinolone acetonide otic solution for the treatment of otic eczema.

This study aimed to determine the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin (FAHT) cream for the treatment of moderate and severe facial melasma. The primary objective was assessment of clinical efficacy, instrumental measured efficacy, and integral therapeutic efficacy at the end of weeks 4 and 8. A total of 233 subjects were randomly allocated (1:1 ratio) to receive topically administered FAHT cream (n = 117) or placebo (n = 116) once nightly for 8 weeks. Observed side effects were documented throughout. In the per protocol set (PPS; those subjects who met all requirements of the protocol), the integral therapeutic efficacy rate of FAHT cream on moderate and severe melasma was 68.57 % (vs. placebo, 0.94 %), the clinical effective rate of FAHT cream was 74.29 % (vs. placebo, 0.94 %), and the instrumental measure efficacy of FAHT cream was 71.43 % (vs. placebo, 6.60 %). The difference in efficacy between the two groups was statistically significant (p

Background To compare visual function and structural improvements in pseudophakic eyes with diabetic macular oedema (DMO) treated with the 0.19mg Fluocinolone Acetonide (FAc) intravitreal implant (IluvienTM) in a ‘real world’ setting. Methods A single centre retrospective evaluation of patients with DMO unresponsive to conventional treatment treated with the FAc implant according to UK guidelines. Primary efficacy endpoint was best corrected visual acuity (BCVA); secondary endpoints included optical coherence tomography evaluations of the macula (a) central retinal and (b) peak macular thickness collected at annual time points. Primary safety endpoint was new rise in IOP >27mmHg or glaucoma surgery. Patients with

Purpose To compare the intraocular pressure (IOP) outcomes of Ahmed glaucoma valve (AGV) surgery alone versus AGV with fluocinolone implant in uveitic glaucoma patients. Methods We identified uveitic glaucoma patients with AGV surgery alone and AGV surgery combined with fluocinolone implant from the Massachusetts Eye and Ear Ocular Inflammation Database. Demographic information, visual acuity, and IOP were recorded at preoperative visits and 1, 6, and 12 months after surgery. Incidence of hypertensive phase, defined as an IOP of >21 mm Hg or use of additional treatment to lower IOP occurring any time between 7 days to 6 months postoperatively, was investigated. Multilevel mixed effects models were performed to compare the outcomes between groups. Results Eighteen eyes of 13 uveitic glaucoma patients with 1-year follow-up data were included. There were 11 eyes of 9 patients (mean age, 56.5 years; 63.6% male) in the AGV group and 7 eyes of 4 patients (mean age, 61.3 years; 71.4% male) in the AGV + fluocinolone group. There was no significant difference in visual acuity change at 1 year after surgery between groups (P = 0.25), although visual acuity improvement was significant in the AGV group (P = 0.01). The hypertensive phase occurred in 91% of AGV patients and 43% of AGV + fluocinolone patients (P = 0.30), with onset of 8-40 days (mean, 18 days) after surgery. IOP and number of glaucoma medications decreased at the 1-year postoperative visits in both the AGV group (P < 0.0001, P < 0.0001) and the AGV + fluocinolone group (P = 0.001, P < 0.0001). Compared to the AGV group, the AGV + fluocinolone group used fewer glaucoma medications (0.28 vs 1.30 [P = 0.01]) and had better inflammation control (P = 0.02). The surgical complication rates were similar between groups. Conclusions In uveitic glaucoma, AGV with fluocinolone achieves a similar, desired IOP control but with fewer glaucoma medications than AGV alone.

To compare visual and anatomical outcomes between eyes treated with fluocinolone acetonide (FAc) 190 µg intravitreal implant for clinically significant chronic diabetic macular edema (DME) and fellow eyes not treated with FAc implant using data from the Iluvien Clinical Evidence study in the UK (ICE-UK) study.In this retrospective cohort study, data on people attending hospital eye services and treated with the FAc implant between April 1, 2013 and April 15, 2015 were collected. Changes in visual acuity (VA), central foveal thickness (CFT) and intraocular pressure (IOP) were compared between study eyes (intervention) and fellow eyes.A total of 208 people were selected. Mean age was 68.1 years and 62% were male. Mean change in VA was -0.09 LogMAR units for study eyes and 0.04 LogMAR units for fellow eyes at 12 months post-implant (p .001). Over the same period, ≥5 letter, ≥10 letter and ≥15 letter improvements in Early Treatment Diabetic Retinopathy Study (ETDRS) score were achieved by more FAc treated eyes than by fellow eyes (41% versus 23%, p .001; 28% versus 11%, p .001; and 18% versus 4%, p .001 at 12 months, respectively). Differences in the mean change in CFT (-113 µm versus -13 µm, p .001) and IOP (3.2 mmHg versus -0.2 mmHg, p .001) were also observed between study and fellow eyes at 12 months.Visual acuity improved in study eyes over the 12 months following FAc implant and worsened in fellow eyes. Over the same period, study eyes showed a larger improvement in central foveal thickness. Intraocular pressure worsened in study eyes only. Change in visual acuity, central foveal thickness and intraocular pressure between FAc implant and the end of the 12-month follow-up period differed significantly between study and fellow eyes.