24 month phase, 1/2 clinical trial of bimatroprost sustained-release implant (Bimatroprost SR) in glaucoma patients: intraocular pressure reduction, safety, and longevity of effect

Session Details

Session Title: Glaucoma & Posterior Segment

Session Date/Time: Monday 24/09/2018 | 08:00-10:30

Paper Time: 08:12

Venue: Room A3, Podium 1

First Author: : R. Craven BELGIUM

Co Author(s): :    I. Stalmans   K. Martin   J. Serle   T. Walters   M. Chen        

Abstract Details

Purpose:

Poor adherence to topical intraocular pressure (IOP)-lowering medication is common in glaucoma. A biodegradable bimatoprost sustained-release implant (BimSR) was developed to address nonadherence in the glaucoma population. This phase1/2 study evaluated the safety and IOP-lowering effect of BimSR in patients with glaucoma. The duration of the IOP-lowering effect of a single administration of BimSR was also analyzed.

Setting:

A total of 27 clinical practices in 6 countries (Australia, Canada, Israel, Philippines, Singapore, and the USA) enrolled and treated patients under the study protocol.

Methods:

This 24-month, dose-ranging, open-label, paired-eye study was conducted in 75 patients with baseline mean IOP in both eyes of 22–36 mmHg post-washout. Study eye received BimSR (6, 10, 15, 20 μg) intracamerally and fellow eye received topical bimatoprost 0.03% daily. Rescue topical medication or one BimSR retreatment was permitted. Long-term IOP-lowering effect was evaluated by IOP change from baseline, time to additional IOP-lowering treatment, and percentage of patients without additional IOP-lowering treatment. Safety measures included reported adverse events (AEs). Results are focused on BimSR 10 and 15 μg dose strengths (n=21 each) chosen for phase 3 clinical trials

Results:

Mean week-12 IOP reduction was 6.5-7.9 mmHg across dose strengths. By month 4, 90.5% and 100% and by month 6, 66.7% and 66.7% were controlled after initial BimSR 10- and 15-ug, respectively. At month 24, 23.8% of patients were still on BimSR monotherapy and in that subgroup, mean IOP reduction was 7.3 and 7.4 mmHg for 10- and 15-ug, respectively. Median time to additional treatment was 38–39 weeks. AEs were similar across dose strengths. Hyperemia beyond the post-administration phase was notably less frequent after BimSR compared to bimatoprost drops. Procedure-related side-effects were of short duration and mostly mild.

Conclusions:

BimSR showed a favorable IOP-lowering effect and safety profile in patients with glaucoma. A single BimSR lasted for at least 4 months and up to 24 months for a subset of patients. These findings demonstrate the potential of BimSR to address the problem of patient nonadherence, supporting the further clinical development of BimSR; phase 3 trials are currently underway.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented