Double-Masked Controlled Trial of H-1337 as a Treatment for Glaucoma and Ocular Hypertension.

The Effectiveness and Safety of Micropulse Cyclophotocoagulation in the Treatment of Ocular Hypertension and Glaucoma

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To compare the effect of time on therapy, efficacy, tolerability and resource utilization of latanoprost or non-prostaglandin analogues (non-PGs) in patients who required a change in intraocular pressure (IOP)-lowering monotherapy. This open-label, multicentre study (Sweden, 19 sites; Finland, seven sites) included adults with glaucoma or ocular hypertension with mean diurnal IOP > or = 21 mmHg on ocular hypotensive monotherapy. Patients were randomized to latanoprost monotherapy or non-PG therapy (commercially available therapy other than a PG) and followed for 36 months. End-points included: time to treatment failure (baseline to visit with a change in/addition to treatment); diurnal IOP (mean of 08.00, 12.00 and 16:00 hr measurements) at months 6, 12, 24 and 36; tolerability; and resource utilization, where analyses used Swedish and Finnish 2006 unit costs. Three hundred and twenty-six patients received >or = 1 dose of latanoprost (n = 162) or non-PGs (n = 164). Median time to treatment failure was longer for latanoprost (36 months) than for non-PGs (12 months; p < 0.001); 51% and 24% of patients remained on randomized therapy after 36 months, respectively (p < 0.001). Decreases in mean diurnal IOP from baseline were significantly greater for latanoprost than for non-PGs at months 6 and 12 (p < 0.01). No serious adverse events were judged to be treatment-related. Mean total 36-month direct costs were similar in patients initiated with latanoprost and non-PGs. Patients who failed previous monotherapy remained on therapy longer when switched to latanoprost. Latanoprost's IOP-reducing effect and tolerability were sustained over the long term. Resource utilization and costs were generally similar in those initiating latanoprost or non-PG therapy.

Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: A randomized clinical trial

Purpose: To evaluate the safety and effectiveness of ab-interno microcatheterization and 360° viscodilation of Schlemm’s canal (SC) using the VISCO360® Viscosurgical System in treatment of primary open angle glaucoma (POAG).Setting: Surgical center (Augencentrum Köln, Köln, Germany).Design: Retrospective analysis of 106 eyes from 71 consecutive patients.Methods: Ab-interno canal viscodilation (VISCO360®) with or without cataract extraction was performed in two groups of patients with mild-moderate POAG: Group 1 had a baseline intraocular pressure (IOP) ≥18 mmHg (n=72 eyes) and Group 2 had a baseline IOP <18 mmHg (n=34 eyes). IOP without washout was measured and number of IOP-lowering medications were documented at all visits. Effectiveness was determined by reduction in IOP and reduction in the number of IOP-lowering medications at 12±3 months from baseline. Safety was determined by the rate of adverse events (AEs) and secondary surgical interventions (SSI).Results: In Group 1, all eyes available at 12±3 months (n=72), had a 41.0% reduction in mean IOP (from 24.6±7.1 mmHg to 14.6±2.8 mmHg), 87% (n=62) of which showed an IOP reduction of ≥20% with no increase in IOP-lowering medications. In Group 2, all eyes (n=34) maintained their baseline IOP at all postoperative visits. In both groups, a significant decrease (>89%) in mean number of IOP-lowering medications was seen at 12 months with 86% of eyes completely off medication with no increase in IOP. The most common AE seen was hyphema (13%) and no eye required SSI during the study period.Conclusion: Ab-interno SC viscodilation (VISCO360) is safe and effective in lowering IOP and reducing hypotensive medications in patients with OAG.

Purpose:To compare intraocular pressure (IOP) reduction achieved in patients treated with two different laser trabeculoplasty technologies over a 6-month follow-up period.Design:This was a quasi-experimental, interventional study.Methods:Patients with indications for laser trabeculoplasty were included. One eye of each patient was randomly assigned to receive selective laser trabeculoplasty (SLT), while the other received micropulse laser trabeculoplasty (MLT). A glaucoma specialist monitored each patient for 6 months. IOP data were recorded at 1, 3, and 6 months post-intervention.Results:A total of 296 eyes from 148 patients were analyzed. Indications for trabeculoplasty were primary open-angle glaucoma in 93 patients (62.8%), ocular hypertension in 28 (18.9%), primary angle-closure glaucoma in 24 (16.2%), and pigmentary glaucoma in 3 (2.0%). No significant difference in IOP reduction was observed between the two groups. The mean IOP reduction was 2.77 mmHg (17.3%) and 2.81 mmHg (17.5%) in the MLT and SLT groups, respectively. Both groups showed significant differences between baseline and final IOP. The mean baseline IOP was 16.1 mmHg and 16.0 mmHg, and the final IOP was 13.3 mmHg and 13.2 mmHg for the MLT and SLT groups, respectively. No treatment-related complications were reported, and no significant differences in the need for re-treatment or filtering surgery were observed.Conclusions:Laser trabeculoplasty is an effective treatment for glaucoma and/or ocular hypertension. IOP reduction was comparable between MLT and SLT, with no significant differences between the two technologies. Their favorable safety profile makes them an excellent choice as either a first-line or adjuvant treatment for IOP control.

In previous analyses of primary efficacy data from two randomized clinical trials, standard dosing regimens of the dorzolamide/timolol fixed combination (COSOPT) and latanoprost (XALATAN) were shown to have equivalent efficacy with regard to reduction in mean daytime diurnal intraocular pressure (IOP). We performed additional post hoc analyses of pooled data from these studies to compare further the efficacy of the two treatments. The studies used identical 3-month, parallel group, randomized, observer-masked and patient-masked, multicenter designs. Patients with a baseline IOP > or = 24 mm Hg were randomized to either the 2% dorzolamide/0.5% timolol combination eye drops twice daily (n = 273) or 0.005% latanoprost eye drops once daily (n = 271). The IOP measurements were made at 8 AM, 10 AM, 2 PM, and 4 PM at the baseline visit and then on each of the 3 monthly assessment days. The following measures were analyzed on a post hoc basis: 1) percentages of patients meeting target levels of IOP reduction; 2) mean IOP reduction in those patients with high IOP (> or =30 mmHg) at baseline; 3) mean IOP at each of the assessment time points during a day. A total of 259 patients in the dorzolamide/timolol group and 268 patients in the latanoprost group were included in the efficacy analysis. At 3 months, both treatments showed similar efficacy with regard to the percentages of patients who achieved target levels of IOP reduction (e.g., 40% IOP reduction in 15% of dorzolamide/timolol combination patients and 13% of latanoprost patients), mean IOP reduction in those patients with high IOP at baseline (dorzolamide/ timolol combination, 12.5 mmHg, latanoprost, 12.6 mmHg), and mean IOP at each time point during the day. By the measures used in this analysis, the dorzolamide/timolol combination and latanoprost were equally effective at lowering IOP in patients with ocular hypertension or glaucoma.

Latanoprost versus timolol gel-forming solution once daily in primary open-angle glaucoma or ocular hypertension.

Background Selective laser trabeculoplasty (SLT) is a safe and effective treatment modality for lowering intraocular pressure (IOP). Purpose To determine the efficacy and safety of SLT among Ethiopian patients with primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PXG), and ocular hypertension (OHT). Method A prospective, nonrandomized interventional study was conducted at Menelik II Hospital, Ethiopia. Patients on antiglaucoma medication with uncontrolled IOP and those patients treated for the first time with 360 degrees of SLT were included. Success was defined as an IOP lowering of > 20% from baseline without repeat treatment. Result A total of 95 eyes of 61 patients with a diagnosis of OAG and OHT were enrolled. The diagnosis was POAG in 55 (57.9%) eyes, PXG in 22 (23.2%) eyes, and OHT in 18 (18.9%) eyes. Seventy (73.7%) eyes were on medications, and 25 (26.3%) eyes were treated with laser as primary therapy. The mean (SD) baseline IOP and medication were 24.3 ± 2.5 mmHg and 1.29 ± 1.01, respectively. The one-year mean (SD) IOP reduction was 6.7 ± 4.2 mmHg and medication reduction was 0.26 ± 1.34. The overall IOP reduction at 12 months was 27.6%, and the success rate was 60%. The mean IOP (SD) reduction for patients who were treated for the first time with laser and on antiglaucoma medication was 6.5 ± 3.1 mmHg and 6.8 ± 2.8 mmHg, respectively. Post-SLT, patients experienced transient ocular pain, brow ache, headache, and/or blurring of vision in 31.6%, anterior chamber reaction in 36.8%, and IOP spike ≥ 6 mmHg in 11.6%. Conclusion SLT is an effective and safe treatment modality for OHT, POAG, and PXG among Ethiopian patients either as a first-line treatment or as an adjunct to topical glaucoma treatment.

To compare the intraocular pressure (IOP) reduction by latanoprost and timolol, and to study factors of prognostic value for assessing this reduction. We analyzed 829 patients included in three phase 111 studies comparing six months' treatment with 0.005% latanoprost once daily and 0.5% timolol twice daily in patients with open-angle glaucoma or ocular hypertension. Analysis of covariance controlled for differences in baseline IOP and sex was used to assess the IOP reduction. Latanoprost reduced diurnal IOP (average of morning, noon and afternoon assessments) by 7.7 mmHg (31%) and timolol by 6.5 mmHg (26%) after six months of treatment. Thus the diurnal IOP was reduced 1.2 mmHg (18%) more with latanoprost than with timolol (p<0.001). Latanoprost-treated patients showed a further decrease in morning IOP of 0.7 mmHg (9%, p<0.001) from the initial morning IOP reduction obtained at two weeks. No such further decrease in IOP was seen with timolol. Higher baseline diurnal IOP resulted in a larger diurnal reduction during treatment with both drugs (p<0.001). Diurnal IOP in women was reduced 0.7 mmHg (11%) less than males with both drugs (p<0.001). Latanoprost was more effective than timolol in reducing mean diurnal IOP. The effect after two weeks was maintained for timolol while with latanoprost there was a further, significant IOP reduction from two weeks to six months. Baseline IOP was the only factor of clinical importance found to be of prognostic value for assessing the IOP reduction.

Efficacy of brimonidine 0.2% and dorzolamide 2% as adjunctive therapy to beta-blockers in adult patients with glaucoma or ocular hypertension

Comparison of brimonidine with latanoprost in the adjunctive treatment of glaucoma

Once-daily (p.m.) netarsudil ophthalmic solution 0.02% (Rhopressa) is approved in the United States for lowering elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Netarsudil, a Rho kinase (ROCK) inhibitor that lowers IOP primarily by increasing trabecular outflow, produces statistically and clinically significant reductions in mean IOP from baseline, with comparable effects on nocturnal and diurnal IOP. In three phase III trials of patients with elevated IOP, the ocular hypotensive efficacy of once-daily netarsudil 0.02% met the criteria for noninferiority to twice-daily timolol 0.5% at all time points over 3 months in patients with baseline IOP less than 25 mmHg. The most frequent adverse event (AE) was generally mild conjunctival hyperemia, the severity of which did not increase with continued dosing. Netarsudil was associated with minimal treatment-related serious or systemic AEs, likely due to the lack of systemic exposure. This report summarizes the available preclinical and clinical data on netarsudil.

Update on Microinvasive Glaucoma Surgery.

Six-Month Intraocular Pressure Reduction with a Topical Bimatoprost Ocular Insert: Results of a Phase II Randomized Controlled Study