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Introduction: The aim of this study was to assess the efficacy and safety of fluocinolone acetonide implant (FAci) injected 1 month after the last dexamethasone intravitreal implant (DEXi) in chronic diabetic macular oedema (DME) patients. Methods: Retrospective multicentric study conducted in pseudophakic patients with chronic DME frequently treated with dexamethasone intravitreal implant (DEXi; time to DME recurrence ≤ 6 months), receiving FAci 1 month after the last DEXi, with at least a 6-month follow-up. Best-corrected visual acuity (BCVA), central macular thickness (CMT) on optical coherence tomography, intraocular pressure (IOP) and additional treatments were assessed on the day of FAci injection (M0), 1 (M1) and 3 months (M3) later and then every 3 months. Results: A total of 41 eyes from 34 patients were included. At M0, patients' mean age was 68.7 ± 9.8 years, the mean DME duration was 63.9 ± 22.9 months, the mean interval between two DEXi was 14.2 ± 3.3 weeks. M12 data were available for 71% of patients. At baseline, the mean BCVA, CMT and IOP were 63.2 ± 16.6 letters, 299.4 ± 103.3 µm, and 16.2 ± 4.5 mmHg, respectively, and remained stable during the follow-up. At M12, 14% of patients required additional intravitreal treatments. Conclusion: In pseudophakic patients with chronic DME showing good response to DEXi but requiring repeated injections every < 6 months, switching to FAci 1 month after the last DEXi was effective and safe. Further prospective randomized controlled studies are needed to confirm these findings, and to determine the best interval between the last DEXi and the first FAci. [ABSTRACT FROM AUTHOR]

Introduction: The 0.19 mg fluocinolone acetonide (FAc) intravitreal implant delivers a continuous intravitreal corticosteroid dose for the treatment of refractory diabetic macular oedema (DMO). The aim of this study was to assess the impact of an FAc intravitreal implant on intraocular pressure (IOP). Methods: We retrospectively collected anonymised data on the patients' characteristics, DMO treatment, and IOP and IOP-lowering treatments before and after the FAc intravitreal implant between September 2013 and March 2020 in several European centres. Results: A total of 221 eyes from 179 patients were included. The mean follow-up duration was 13.4 (± 12.5, range 2.4–33.5) months. Overall, 194 eyes (88.2%) had received an intravitreal dexamethasone injection before the FAc intravitreal implant. For 25 eyes (11.3%) there was a history of glaucoma, and 52 eyes (23.5%) had previous IOP-lowering treatment. Mean IOP before injection was 14.7 (3.4) mmHg and increased to 16.9 (3.7) mmHg 12 months after injection (P < 0.0001). During follow-up, 55 eyes (24.9%) required the addition or initiation of topical IOP-lowering medication, only one patient (0.5%) had laser trabeculoplasty and one patient (0.5%) a minimally invasive glaucoma surgery, and no patient required incisional IOP-lowering surgery. Conclusion: The FAc intravitreal implant led to substantial IOP elevation. This elevation was monitored most of the time with addition or initiation of topical IOP-lowering medication. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to investigate changes in macular perfusion in patients affected by diabetic macular edema (DME) and treated with ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg using optical coherence tomography angiography (OCTA). Methods: This was a retrospective cohort study that included patients aged > 18 years with type 2 non-proliferative diabetic retinopathy (DR) and DME at baseline. All patients were treated with the ILUVIEN® implant. A minimum of two 6 × 6-mm OCTA scans were required to ensure that all cases had a baseline OCTA and an OCTA performed at 4 months of follow-up. Qualitative and quantitative comparisons were performed. Results: Ten eyes from ten subjects were included in the analysis. Mean (± standard deviation) age of the study cohort was 57.1 ± 8.3 years. Mean parafoveal perfusion density (PD) at baseline was 64.1 ± 1.8% at baseline, increasing to 66.1 ± 2.9% (p = 0.013) at the 4-month follow-up visit. Mean parafoveal PD at baseline was 64.4 ± 2.1%, increasing to 65.2 ± 2.6% (p = 0.024) after 4 months. In the qualitative assessment, 60 regions (10 areas for each subject) were graded to assess changes in retinal perfusion between the baseline and follow-up visits. This assessment revealed that 24 regions (40.0%) were characterized by a qualitative increase in perfusion after treatment, while 22 (36.7%) and 14 (23.3%) regions were featured by a stability and reduction in retinal perfusion, respectively. Conclusion: OCTA analysis detects improvements in macular perfusion after treatment with ILUVIEN®. This improvement in macular perfusion may be associated with corticosteroid-related beneficial effects on leukostasis. [ABSTRACT FROM AUTHOR]

Intravitreal therapy for diabetic macular edema can, in susceptible patients, increase intraocular pressure (IOP). As uncontrolled IOP can potentially be sight threatening, monitoring is an essential component of patient management. It can be challenging for retina specialists to ensure that monitoring is rigorous enough to detect and resolve any potential problems at the earliest opportunity without it also being overburdensome for patients who have the lowest risk of developing an IOP rise. We have developed dynamic algorithms that: (1) tailor the frequency and extent of monitoring according to individual susceptibility and current IOP and (2) assist retina specialists in deciding when they should consider a referral to a glaucoma specialist. One algorithm is for patients with a relatively low susceptibility to developing an IOP rise (those whose baseline IOP is < 22 mmHg and who do not have a history of IOP events). Depending on their first post-implantation IOP check, the algorithm classifies them as: low risk if IOP remains < 22 mmHg; medium risk if IOP is 22–25 mmHg and any rise from baseline is < 10 mmHg; or high risk if IOP is > 25 mmHg or any rise from baseline is ≥ 10 mmHg. Thereafter, the algorithm guides on the frequency and extent of monitoring required in each of these groups and, if IOP rises or falls during treatment, patients may move up or down the risk groups accordingly. A different algorithm is provided for patients who are more susceptible to developing an IOP rise (those with a baseline IOP of ≥ 22 mmHg or a prior history of an IOP event). These patients need monitoring more closely so this algorithm has only medium- or high-risk classifications. These algorithms update the previous monitoring guidance by Goñi et al. (Goñi et al. in Ophthalmol Ther 5:47–61, 2016). Plain Language Summary: Some people with diabetes have macular edema, which is a swelling of the central part of the retina (the tissue that lines the back of the eye). This swelling can threaten eyesight if untreated. Injecting a drug such as a corticosteroid into the eye can help treat the condition. Sometimes this has a side effect of increasing intraocular pressure (pressure within the eye). A small or short-lived rise in eye pressure should be no cause for concern, but it is very important to ensure the pressure is not too high for too long—because this could lead to the loss of eyesight. To prevent this happening, an eye doctor needs to check the eye pressure regularly. Some people are more susceptible to this problem—for example, people who have had any problems related to eye pressure in the past or people whose eyes already have a higher than normal pressure even before treatment. People who are most susceptible may need more types of checks and more frequent checks to ensure that any problems are found and treated quickly. We have developed flowcharts that help eye doctors decide which checks are needed and how often based on what the doctor knows about the person's eye before treatment and what they see at each check-up after treatment. They help doctors make sure that everyone has check-ups at the right time and they help doctors spot any problems early so that they can be resolved before long-lasting damage can occur. [ABSTRACT FROM AUTHOR]

Introduction: Treatment of juvenile idiopathic arthritis (JIA)-associated uveitis necessitates the use of long-term corticosteroids or immunosuppressive agents, each of which poses their own significant side effect profile. Initial treatment requires intensive topical glucocorticoids, with a step-up approach employing immunosuppressive agents for those cases with poor response or high-risk complications such as macular oedema. To date, there is minimal evidence to support a specific approach to such complicated subgroups. We present the first case to successfully employ the 0.19 mg fluocinolone acetonide implant (ILUVIEN®, Alimera Sciences, Hampshire, UK) as a novel device for prolonged intravitreal administration of disease-modifying agents for patients with JIA complicated by uveitis. Methods: This retrospective case report describes a 20-year old woman diagnosed with oligoarticular JIA complicated by chronic uveitis and associated cystoid macular oedema (CMO). Considering factors including the patient's non-compliance, age, lens status, non-steroid response, and good response to short-term intravitreal steroid therapy, the 0.19 mg fluocinolone acetonide intravitreal implant was deemed an appropriate step-up treatment option. Results: At 12-month follow-up, the left eye (OS) showed an improvement in visual acuity to 6/15 − 1 from 6/60 + 1 (0.42 from 0.98 logMAR) (pre-insertion) and a reduction in central retinal thickness (CRT) of 199 μm from 471 μm. The right eye (OD), treated 10 months later, showed an improvement in visual acuity to 6/7.5 from 6/24 − 1 (0.10 from 0.56 LogMAR) and a reduction in CRT of 327 μm 6 months after treatment. Conclusion: In this case, the 0.19 mg fluocinolone acetonide implant provided safe and effective long-term treatment of JIA-associated uveitis and secondary CMO. This potentially offers an alternative approach to complex cases that show good response to short-term corticosteroid use. [ABSTRACT FROM AUTHOR]

Introduction: We aimed to evaluate the impact of foveal eversion on treatment response and persistent diabetic macular edema (DME). Methods: The study was designed as interventional and prospective. DME eyes were treated with ranibizumab and/or dexamethasone (DEX) implants, or with fluocinolone acetonide (FAc) implants. FAc-treated eyes were eventually retreated by additional ranibizumab injections. Main outcome measure was the relationship between foveal eversion and both clinical outcome and persistent DME. Results: Sixty-eight DME eyes (68 patients) treated by anti-VEGF/DEX and 50 FAc-treated eyes (50 patients) were recruited. The follow-up was 16 ± 3 months. The anti-VEGF/DEX group and FAc-treated group were statistically matched for age, sex, DME duration and previous number of injections (p > 0.05). Both groups experienced statistically significant improvements of both BCVA and central macular thickness (p < 0.01) at the end of the follow-up. Persistent DME was shown by 46% of anti-VEGF/DEX eyes and 42% of FAc-treated eyes. Foveal eversion was found in 50% of anti-VEGF/DEX eyes and in 44% of FAc-treated eyes. Its presence was associated with worse anatomical and visual outcome and higher persistence of DME in both groups (p < 0.01) and with higher retreatment percentages in FAc-treated eyes (p < 0.01). Conclusion: Foveal eversion is associated with worse clinical and morphological outcomes in DME. [ABSTRACT FROM AUTHOR]

Introduction: To determine anatomical, functional, and intraocular pressure (IOP) responses to diabetic macular edema (DME) treatments pre- and post-0.2 µg/day fluocinolone acetonide (FAc) implant administration compared with baseline and the preceding 3 years.Methods: This was a retrospective, chart review, cohort study in four U.S. centers. Patients received the 0.2 µg/day FAc implant for the treatment of DME in at least one eye before January 1, 2016. DME treatments administered up to 36 months pre-FAc implant and up to 24 months post-FAc implant were recorded, and treatment frequency was calculated. Visual acuity (VA) was assessed using a Snellen eye chart and converted to early treatment diabetic retinopathy study (ETDRS) letters, and central subfield thickness (CST) was measured using optical coherence tomography (OCT). Treatment frequency, mean VA, mean CST, percentage of patients with CST of ≤ 300 µm, mean IOP, IOP events, and IOP treatments pre- and post-FAc implant administration were measured. Positive and negative predictive values for the IOP response to prior steroid therapy were also determined.Results: In total, 160 eyes of 130 patients were studied. VA was maintained at pre-FAc levels from baseline to month 24, despite a significant reduction in treatment frequency from one treatment every 2.9 months pre-FAc implant to one treatment every 14.3 months post-FAc implant. Patients with better baseline VA required fewer DME treatments post-FAc than did patients with worse baseline VA. The majority of patients did not require additional DME treatment during the post-FAc follow-up period. A significant reduction in CST and an increase in the percentage of patients with CST of ≤ 300 µm were seen up to month 21 post-FAc implant. Pre-FAc implant IOP was maintained during the post-FAc implant period; increased IOP with prior steroid therapy was found to be highly predictive of increased IOP post-FAc implant.Conclusion: The results of this study confirm the positive safety and efficacy profile of the FAc implant and demonstrate for the first time the effectiveness of the U.S. label indication of FAc in reducing the incidence of post-treatment pressure elevation. The FAc implant significantly reduced treatment burden in the overall population without significantly increasing the risk of steroid-induced pressure elevation.Funding: Alimera Sciences. [ABSTRACT FROM AUTHOR]

Diabetic macular edema (DMO) is a leading cause of blindness in the working age population. Although anti-vascular endothelial growth factor (VEGF) therapy provided a major advance in treatment of DMO for many patients, there is a significant proportion of patients who maintain persistent DMO and have minimal response to anti-VEGF treatment. Iluvien (fluocinolone acetonide 0.19 mg [FAc]) is an important additional treatment option for DMO. In this review we describe the clinical context and the evidence for the use of the FAc implant in treating DMO, from pilot to randomized controlled studies, to later phase real world data. These studies indicate that the FAc implant is effective, well tolerated and a cost-effective option in the treatment of insufficiently responsive DMO. [ABSTRACT FROM AUTHOR]

Introduction: It is hypothesized that using fluocinolone acetonide (FAc) implants such as Iluvien for the treatment of diabetic macular edema (DME) may reduce the total number of intravitreal injections and clinic visits, resulting in an overall treatment cost reduction. The primary aim of this study is to identify the real-world cost savings achievable in a tertiary National Health Service (NHS) hospital.Methods: A retrospective cost analysis study was conducted. The inclusion criteria were patients with refractory DME who were switched to Iluvien. The average yearly costs were calculated both before and after the switch to Iluvien. All costs including medicines, investigations, clinics, and management of raised intraocular pressure (IOP) were calculated. The cost differences over the 3 years’ worth of Iluvien treatment were calculated and analyzed. To ensure non-inferiority of this treatment intervention, the best corrected visual acuity (BCVA) and central retinal thickness (CRT) were also analyzed. Statistical analysis was conducted with a Student t test where appropriate and statistical significance is identified where p < 0.05.Results: Fourteen eyes of 13 patients met the inclusion criteria. Switching patients to Iluvien achieved on average a saving of £2606.17 per patient (p = 0.33) over the 3 years. However, seven cases (50%) had a rise in IOP after Iluvien that warranted medical treatment and two cases (14.3%) required glaucoma surgery. Incorporating the costs of glaucoma management reduced the overall savings over 3 years to £1064.66 per patient. The BCVA and CRT analysis showed a non-inferiority relationship between Iluvien and any previous treatment.Conclusions: The use of Iluvien in refractory DME patients represents a cost- and time-saving procedure, while showing non-inferiority in terms of efficacy. [ABSTRACT FROM AUTHOR]

Introduction: Glaucoma is a known complication of uveitis, and may require glaucoma tube shunt implantation for intraocular pressure (IOP) control. The success of glaucoma tube shunt implantation in the setting of a local ocular steroid depot in uveitic glaucoma remains unknown. The purpose of this study was to determine whether patients who underwent combined glaucoma tube shunt (Ahmed) and fluocinolone acetonide (Retisert™, Bausch + Lomb, Bridgewater, NJ, USA) implantation have superior outcomes compared to patients with Ahmed implants only in the setting of uveitic glaucoma. Methods: All participants were studied retrospectively and underwent Ahmed implantation alone or with existing/concurrent Retisert implantation (combined group) at a single academic institution. The main outcome measures were IOP, visual acuity (VA), number of IOP-lowering medications, and adverse events at 6 months after Ahmed implantation. Secondary outcome measures included adverse events and surgical success at 6 months after Ahmed implantation. Results: Mean IOP at 6 months after Ahmed implantation was 15.3 ± 4.8 and 15.1 ± 4.9 mm Hg in the Ahmed only group ( n = 17) and the combined group ( n = 17), respectively ( p = 0.89). The mean number of IOP-lowering medications at 6 months after Ahmed implantation was 1.7 ± 1.0 and 1.8 ± 1.0 in the Ahmed only group and the combined group, respectively ( p = 0.86). Mean VA at 6 months after Ahmed implantation was 0.35 ± 0.29 and 0.42 ± 0.33 log mean angle of resolution in the Ahmed only group and the combined group, respectively ( p = 0.50). No significant differences in surgical success or adverse events were noted between the two groups. Conclusion: At 6 months, no significant differences in mean IOP, mean number of IOP-lowering medications, VA, surgical success, or adverse events were noted between Ahmed implantation alone or combined Ahmed and Retisert implantation in patients with uveitic glaucoma. [ABSTRACT FROM AUTHOR]

Introduction: Patients with diabetic macular edema (DME), a chronic, vision-limiting condition, may be insufficiently responsive to standard-of-care anti-vascular endothelial growth factor (VEGF) and/or laser therapies. One approved treatment for such patients is 0.2 μg/day fluocinolone acetonide (FAc) sustained-release implant; however, data are limited for treatment strategies in patients with bilateral chronic DME insufficiently responsive to standard-of-care therapies. Methods: Six pseudophakic patients with bilateral, chronic DME previously treated with laser and anti-VEGF therapy (and intravitreal triamcinolone acetonide in 10 eyes) were retrospectively investigated for visual and anatomical outcomes, 6 months post-0.2 μg/day FAc implant in both eyes. Results: At baseline, the mean best corrected visual acuity (BCVA) was approximately 6/38 or 43 [standard deviation (SD) ±17.4] Early Treatment Diabetic Retinopathy Study (ETDRS) letters; mean central retinal thickness (CRT) was 648 μm (SD ±160). Mean change in BCVA was +10 letters (SD ±12.2 letters), with 4/12 eyes maintaining or achieving driving vision (≥70 letters) and 3/12 eyes having unchanged BCVA. CRT was reduced 6 months after 0.2 μg/day FAc implant in 11/12 eyes. The mean intraocular pressure (IOP) was 16.1 mmHg [mean change of 1.1 mmHg (SD ±3.6)]. Conclusion: In a real-world setting, 0.2 μg/day FAc implant in both eyes was a feasible, effective choice for patients with severe bilateral DME, without notable increases in IOP. Funding: Publication charges were funded by Alimera Sciences Ltd. Medical writing assistance for this study was provided by QXV Communications and funded by Alimera Sciences Ltd. [ABSTRACT FROM AUTHOR]

Introduction: We describe a proactive method using electronic patient records (EPR) to identify pseudophakic patients with diabetic macular oedema (DMO) that might benefit from treatment with 0.2 µg/day fluocinolone acetonide (FAc; ILUVIEN) implant. Methods: Our EPR audit tool (Medisoft) identified diabetic patients (May 2011-December 2014) with National Screening Committee-confirmed grade M1 maculopathy. Searches segmented this DMO patient population into patient groups who: (1) had received ranibizumab therapy, (2) had received ≥2 macular laser treatments, or (3) were unsuitable for macular laser or ranibizumab therapy. Pre-specified criteria identified patients insufficiently responsive to treatment, and their electronic case notes were flagged for clinicians to consider FAc, based on National Institute for Health and Care Excellence (NICE) TA301. Results: Using this methodology, 138 patients with DMO were identified, of whom 87 were assigned to group 1, 32 to group 2, and 29 to group 3 (10 patients were included in both groups 2 and 3). From these, 28 different pseudophakic eyes were identified as suitable for treatment with FAc, based on insufficient response to prior treatment. Conclusion: EPR audit offers a real-world methodology to efficiently identify patients that might benefit from treatment with FAc. Limitations apply, and thorough documentation of lens status and ocular comorbidities is vital; however, this approach was more rapid than prospective recruitment through the clinic. Flagging patient records using EPR audit offers a practical process for application to clinical practice, thereby optimizing patient care in line with NICE TA301 guidelines. Funding: Alimera Sciences Ltd. [ABSTRACT FROM AUTHOR]