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Over the last decade several novel surgical treatment options and devices for glaucoma have been developed. All these developments aim to cause as little trauma as possible to the eye, to safely, effectively, and sustainably reduce intraocular pressure (IOP), to produce reproducible results, and to be easy to adopt. The term "micro-invasive glaucoma surgery (MIGS)" was used for summarizing all these procedures. Currently MIGS is gaining more and more interest and popularity. The possible reduction of the number of glaucoma medications, the ab interno approach without damaging the conjunctival tissue, and the probably safer procedures compared to incisional surgical methods may explain the increased interest in MIGS. The use of glaucoma drainage implants for lowering IOP in difficult-to-treat patients has been established for a long time, however, a variety of new glaucoma micro-stents are being manufactured by using various materials and are available to increase aqueous outflow via different pathways. This review summarizes published results of randomized clinical studies and extensive case report series on these devices, including Schlemm's canal stents (iStent®, iStent® inject, Hydrus), suprachoroidal stents (CyPass®, iStent® Supra), and subconjunctival stents (XEN). The article summarizes the findings of published material on efficacy and safety for each of these approaches.

Lutz E Pillunat,1 Carl Erb,2 Auli Ropo,3 Friedemann Kimmich,4 Norbert Pfeiffer5 1Department of Ophthalmology, University Hospital Carl Gustav Carus, Dresden, 2Augenklinik am Wittenbergplatz, Berlin, Germany; 3Santen Europe, Helsinki, Finland; 4eyecons, Pfinztal, 5Department of Ophthalmology, Mainz University Medical Center, Mainz, Germany Background: Efficacy, tolerability and safety of the novel preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% (Taptiqom®) were investigated in an observational study in Germany.Objective: To assess efficacy, tolerability and safety of the preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% in a real-life setting.Methods: Intraocular pressure (IOP) was recorded for each eye at baseline (any previous therapy or untreated) and 4–16 weeks after changing medical treatment to or initiating treatment with the preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5%. Change in IOP was evaluated over the study period for all patients and for specific pretreatment subgroups. Clinical signs such as conjunctival hyperemia and lid-parallel conjunctival folds (LIPCOF) were recorded using standardized comparative photographs. Corneal staining, subjective symptoms and local comfort were measured using a four-step scale. All adverse events were recorded.Results: Among 1,157 patients enrolled, 1,075 patients were treated with the preservative-free fixed combination as the only medication at the final visit. Medical treatment was initiated in 741 patients because of an insufficient IOP-lowering effect of the prior medication. In 343 patients, medication was changed because of tolerability issues. The preservative-free fixed combination lowered IOP significantly in the subgroup of naïve patients, all subgroups with prior monotherapy and patients with prior fixed combinations: naïve patients: −8.9 mmHg, alpha-2-agonists: −6.4 mmHg, beta-blockers: −5.7 mmHg, carbonic anhydrase inhibitors: −5.2 mmHg, prostaglandins: −4.7 mmHg, fixed-combination prostaglandins/timolol: −2.4 mmHg. At the final visit, clinical signs and subjective symptoms were improved in patients with prior medical therapy. Local comfort was rated as “very good” or “good” by 89.1% of patients at the final visit. Only few adverse events occurred during the treatment period.Conclusion: The preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% was effective, well tolerated and showed a good safety profile. Keywords: fixed combination, tafluprost, timolol, glaucoma, preservative-free medication, preservatives

Over the last decade several novel surgical treatment options and devices for glaucoma have been developed. All these developments aim to cause as little trauma as possible to the eye, to safely, effectively, and sustainably reduce intraocular pressure (IOP), to produce reproducible results, and to be easy to adopt. The term “micro-invasive glaucoma surgery (MIGS)” was used for summarizing all these procedures. Currently MIGS is gaining more and more interest and popularity. The possible reduction of the number of glaucoma medications, the ab interno approach without damaging the conjunctival tissue, and the probably safer procedures compared to incisional surgical methods may explain the increased interest in MIGS. The use of glaucoma drainage implants for lowering IOP in difficult-to-treat patients has been established for a long time, however, a variety of new glaucoma micro-stents are being manufactured by using various materials and are available to increase aqueous outflow via different pathways. This review summarizes published results of randomized clinical studies and extensive case report series on these devices, including Schlemm’s canal stents (iStent®, iStent® inject, Hydrus), suprachoroidal stents (CyPass®, iStent® Supra), and subconjunctival stents (XEN). The article summarizes the findings of published material on efficacy and safety for each of these approaches.

Ines Lanzl,1 Thomas Hamacher,2 Klaus Rosbach,3 Mohammed Osman Ramez,4 Robert Rothe,5 Eva Ružicková,6 Marta Karhanová,7 Friedemann Kimmich81Private practice, Prien, Germany; 2Private practice, Starnberg, Germany; 3Private practice, Mainz, Germany; 4Private practice, Buxtehude, Germany; 5Private practice, Minden, Germany; 6General Faculty Hospital, Praha Czech Republic; 7Faculty Hospital Olomouc, Czech Republic; 8eyecons, Pfinztal, GermanyPurpose: The study reported here investigated the efficacy, tolerability, and safety of the preservative-free prostaglandin analog tafluprost 0.0015% in treatment-naive patients.Patients and methods: Data were collected in two non-interventional, prospective, multicenter, observational, open-label studies of identical design that were conducted in Germany and the Czech Republic. All subjects received preservative-free tafluprost 0.0015% once daily. Intraocular pressure (IOP) levels were recorded for each eye at untreated baseline and 3 months after initiation of medical treatment. The primary outcome was change in mean IOP from baseline to month 3. In the primary open-angle glaucoma (POAG) and ocular hypertension (OH) patient subgroups, analyses were stratified by the level of baseline IOP: ≥20 to 23 mmHg versus ≥24 mmHg. In addition, responder rates and the achievement of pre-specified IOP levels at month 3 were evaluated. Local tolerance of preservative-free tafluprost was evaluated by the patients at final visit. Overall satisfaction with the medical treatment was evaluated by both patients and physicians. All adverse events were recorded.Results: A total of 579 treatment-naive patients with POAG (n = 349), OH (n = 105), normal tension glaucoma (n = 71), exfoliative glaucoma (n = 27), or other glaucomas (n = 27) were included in this observational study. Mean IOP level at baseline for all patients was 23.6 ± 4.0 mmHg. Mean IOP at month 3 was 16.8 ± 2.9 mmHg (—28.8% vs baseline). At month 3, significant reductions in mean IOP (P < 0.001) were seen in all patients and all subgroups. Preservative-free tafluprost lowered mean IOP significantly in patients with POAG and OH with IOP levels ≥ 20 to 23 mmHg from 21.9 ± 1.1 mmHg at baseline to 16.5 ± 2.2 mmHg, and in the subgroup with IOP levels ≥ 24 mmHg from 26.2 ± 2.4 mmHg to 17.9 ± 2.4 mmHg. In the subgroups of patients with POAG and OH, an IOP response ≥20%, ≥30%, and ≥40% was achieved by 83.4%, 44.1%, and 12.8%, respectively. Overall, patients with higher baseline IOP values showed a better response than patients with lower baseline IOP levels. Preservative-free tafluprost was well tolerated and safe. After 3 months, 97.9% of all patients remained on therapy.Conclusion: In this real-world observational study, treatment with once-daily preservative-free tafluprost proved efficacious, well tolerated, and safe in treatment-naive patients.Keywords: intraocular pressure, prostaglandin analogs, responders, first-line treatment, preservatives, local tolerabilityA Letter to the Editor has been received and published for this article.

Anton Hommer¹, Friedemann Kimmich²¹Sanatorium Hera, Vienna, Austria; ²eyecons, Pfinztal, GermanyPurpose: Efficacy, tolerability and safety of the novel preservative-free prostaglandin tafluprost 0.0015% were investigated for the treatment of patients with glaucoma or ocular hypertension in a clinical setting.Patients and methods: Data were collected in a non-interventional, prospective, multi-center, observational, open label study. 118 patients were treated with a prostaglandin analog (PGA) monotherapy (preserved formulations of latanoprost, travoprost or bimatoprost) prior to baseline. Intraocular pressure (IOP) readings were recorded for each eye at baseline (previous therapy), 4–6 weeks, and 12 weeks after changing medical treatment to preservative-free tafluprost once-daily. We analyzed the change in IOP over the study period for all patients as well as for a subgroup of patients with prior PGA monotherapy. Subjective symptoms and objective ocular signs were determined. Comfort was measured using a 4 step scale. All adverse events were recorded. Paired t-tests were conducted to compare IOP values at baseline to IOP values after treatment with tafluprost 0.0015%. Bowker’s test of symmetry was used for statistical evaluation of changes of clinical signs (hyperemia).Results: In total 118 patients were eligible for evaluation. In these patients with prior PGA monotherapy (n = 118) IOP decreased significantly from 16.2 ± 4.3 mm Hg (95% CI: 0.55) at treated baseline to 14.8 ± 3.2 mm Hg (95% CI: 0.43; P < 0.001) at final visit on tafluprost. In a subset of patients with prior latanoprost monotherapy (n = 68) mean IOP at baseline (±SD) was reduced from 16.2 ± 4.6 mm Hg (95% CI: 0.77) 14.8 ± 3.1 mm Hg at final visit (95% CI: 0.54, P < 0.001), in patients with prior travoprost monotherapy (n = 32) from 16.2 ± 4.3 mm Hg (95% CI: 1.05) to 14.9 ± 3.3 mm Hg (95% CI: 0.91; P < 0.05) and in patients with prior bimatoprost monotherapy (n = 18) from 16.4 ± 3.5 mm Hg (95% CI: 1.14) to 15.0 ± 3.3 mm Hg (95% CI: 1.14; P = 0.252). Both, objective clinical signs and subjective symptoms improved after changing medication to preservative-free tafluprost until final visit. The number of patients with moderate and severe hyperemia decreased from 51 (43.2%) at baseline to 2 (1.9%) at final visit.Conclusion: Preservative-free tafluprost 0.0015% was effective, well tolerated and safe. IOP was controlled effectively and ocular symptoms and clinical signs were improved after changing medication to a monotherapy with preservative-free tafluprost in patients previously treated with a preserved latanoprost, travoprost or bimatoprost monotherapy.Keywords: tafluprost, intraocular pressure, prostaglandin-analogs, preservatives, local tolerability hyperemia

Objective: To evaluate the efficacy and tolerability of Optive™, a new dry eye product containing sodium carboxymethylcellulose (0.5%) and glycerol (0.9%), in patients with keratoconjunctivitis sicca (KCS). Methods: This was a non-interventional and observational study including patients with dry eye who required a change of medication or were naïve to dry eye treatment (N = 5,277). Disease severity, tear break-up time (TBUT), tolerability, and change in clinical symptoms were recorded at baseline and at final visit (2 to 4 weeks after first treatment). Results: The severity of KCS was mild in 18.6%, moderate in 59.9%, and severe in 21.5% of patients based on physicians’ assessment. TBUT was measured in 4,338 patients before switching to or initiating therapy with Optive and at final visit. Baseline measurement of mean TBUT was 7.7 ± 3.9 seconds. This value increased to 10.0 ± 4.7 seconds at final visit. Most patients (85.4%) reported improvement in local comfort. The majority (75.1%) of patients felt an improvement in symptoms after changing their treatment. Two percent of patients reported adverse events, and 0.4% were treatment-related. Conclusions: Optive was well tolerated and improved the symptoms of dry eye after 2 to 4 weeks.

Thomas Kaercher1, Patricia Buchholz2, Friedemann Kimmich31Augenarztpraxis, Heidelberg, Germany; 2Allergan Europe, Ettlingen, Germany; 3Eyecons, Pfinztal, GermanyObjective: To evaluate the efficacy and tolerability of OptiveTM, a new dry eye product containing sodium carboxymethylcellulose (0.5%) and glycerol (0.9%), in patients with keratoconjunctivitis sicca (KCS).Methods: This was a non-interventional and observational study including patients with dry eye who required a change of medication or were naïve to dry eye treatment (N = 5,277). Disease severity, tear break-up time (TBUT), tolerability, and change in clinical symptoms were recorded at baseline and at final visit (2 to 4 weeks after first treatment).Results: The severity of KCS was mild in 18.6%, moderate in 59.9%, and severe in 21.5% of patients based on physicians’ assessment. TBUT was measured in 4,338 patients before switching to or initiating therapy with Optive and at final visit. Baseline measurement of mean TBUT was 7.7 ± 3.9 seconds. This value increased to 10.0 ± 4.7 seconds at final visit. Most patients (85.4%) reported improvement in local comfort. The majority (75.1%) of patients felt an improvement in symptoms after changing their treatment. Two percent of patients reported adverse events, and 0.4% were treatment-related.Conclusions: Optive was well tolerated and improved the symptoms of dry eye after 2 to 4 weeks.Keywords: keratoconjunctivitis sicca, dry eye, sodium carboxymethylcellulose, glycerol, OptiveTM

The objective of this study was to evaluate efficacy, local tolerability, and safety of this first-in-class preservative-free prostaglandin preparation in patients with ocular hypertension and glaucoma.Patients with glaucoma or ocular hypertension who required a change of medication or were naïve to treatment were included in this noninterventional and observational study. Noninterventional means that no influence was made upon the decision of the physicians to include specific patients and upon the treatment algorithm used. German law for observational studies does not allow any influence on the choice of drugs used, patient selection, masking, and comparator treatment regimens. The main aim of this observational study was to collect "real-life data" on the efficacy and safety of a new medical treatment after approval in a large patient population. Participating ophthalmologists were asked to provide anonymous patient data collected during regular visits by filling a simple data entry form. Intraocular pressure (IOP) readings were recorded at baseline (previous therapy or untreated) and 6-12 weeks after changing medical treatment to or initiating treatment with preservative-free tafluprost once daily. Changes in the IOP were evaluated over the study period for all patients as well as for specific pretreatment subgroups. Local comfort was determined using a five-point scale (very good, good, satisfactory, less satisfactory, not acceptable) before and after the change of medical treatment. All adverse events were recorded.Data from 2123 patients with glaucoma or ocular hypertension were considered for the final evaluation. Medication was changed in 41.1% of patients due to tolerability issues and in 25.6% of patients due to insufficient efficacy with prior medication. In all patients preservative-free tafluprost 0.0015% lowered IOP from 19.5 ± 4.4 mmHg (baseline) to 16.4 ± 2.9 mmHg after 6-12 weeks. Preservativefree tafluprost also significantly lowered the IOP in all monotherapy subgroups: treatment-naïve patients (n=440): 22.6 ± 3.9 mmHg (baseline) to 16.7 ± 2.7 mmHg (week 6-12); beta blockers (n=307): 20.3 ± 3.5 mmHg (baseline) to 16.7 ± 2.6 mmHg (week 6-12); carbonic anhydrase inhibitors (n=158): 19.0 ± 3.6 mmHg (baseline) to 16.0 ± 2.6 mmHg (week 6-12); prostaglandin analogs (PGAs; n=447): 16.8 ± 2.9 mmHg (baseline) to 15.8 ± 2.6 mmHg (week 6-12). Local comfort was rated as "very good" or "good" by 85.6% of patients at the final visit (P0.001). Only few adverse events occurred during the treatment period: 18 patients (0.8%) discontinued medical treatment with preservative-free tafluprost due to local intolerance; six patients (0.3%) due to efficacy issues; four patients complained about systemic side effects (0.2%); and two patients preferred to use a multidose treatment regimen (0.2%).Although this study was limited by its observational design the results demonstrate that preservative-free tafluprost 0.0015% was effective, generally well tolerated, and safe in a broad and heterogeneous patient population.