Effect of sustained-release bimatoprost implant (Bimatoprost SR) on visual field mean deviation in glaucoma patients in a phase 1/2 clinical trial
Abstract
Purpose
Bimatoprost SR (BimSR), a biodegradable intracameral (IC) implant that slowly releases bimatoprost to lower intraocular pressure (IOP), is in Phase III development for glaucoma treatment. The effect of BimSR treatment on the VF (visual field) MD (mean difference) in glaucoma patients was evaluated in a Phase 1/2 clinical trial.
Methods
Phase 1/2, prospective, 24-month, dose-ranging, paired-eye trial in 75 open-angle glaucoma patients with required baseline study eye VF loss (per protocol, MD <−1 and >−17 dB). BimSR (6, 10, 15, or 20 μg) was administered IC in the study eye; the fellow eye received topical bimatoprost 0.03% QD (bim). Rescue topical IOP-lowering medication or a single repeat treatment with implant was allowed. The primary efficacy measure was IOP. Humphrey perimetry 24-2 full threshold or SITA standard VF testing was done every 6 months. Results are presented for the intent-to-treat population and the subgroup treated with the dose strengths of BimSR that are continuing in development (10 and 15 μg).
Results
Mean IOP was reduced by all BimSR dose strengths. IOP was controlled without rescue or retreatment in 68%, 40%, and 28% of BimSR-treated eyes up to 6, 12, and 24 months, respectively. Month 24 mean (SD) change in MD from baseline was +0.20 (3.16) dB in all BimSR-treated eyes (n=59), −0.35 (3.04) dB in all topical bim-treated eyes (n=59), and +0.53 (3.07) dB in BimSR 10- and 15-μg–treated eyes (n=33). Among eyes with no rescue, mean (SD) month 24 change in MD from baseline was +0.71 (3.17) dB in all BimSR-treated eyes (n=25) and −0.15 (3.03) dB in all topical bim-treated eyes (n=55).
Conclusions
These results warrant further investigation to assess VF stability using sustained delivery medications compared to topical therapy.
