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Shamira Perera, Richard A. Lewis, William C Christie, Douglas G Day, E R Craven, Marina Bejanian, Susan S Lee, Margot L Goodkin, Jane Zhang, Michael R Robinson; Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 12-Month Interim Results From a Phase 1/2 Clinical Trial. Invest. Ophthalmol. Vis. Sci. 201657(12):.
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A biodegradable bimatoprost sustained-release implant (BimSR) has been developed to address the problem of nonadherence to topical intraocular pressure (IOP)-lowering medication in the glaucoma population. This study evaluates the safety and IOP-lowering effect of BimSR.
Ongoing, phase 1/2, prospective, 24-month, dose-ranging, paired-eye trial in patients with open-angle glaucoma. After washout of previous IOP-lowering medication, patients (n=75) received an intracameral injection of BimSR (6, 10, 15, or 20 µg Generation 2 formulation) in the study eye and initiated topical bimatoprost 0.03% QD (bim) in the fellow eye. Rescue topical medication or a single repeat treatment with BimSR was allowed for failure to attain target IOP or <20% reduction in IOP, respectively, on consecutive visits ≥1 week apart, or if in the patient's best interest. The primary efficacy endpoint was IOP reduction from baseline. Safety measures included adverse events (AEs).
BimSR provided rapid, sustained IOP lowering (Figure). Overall mean IOP reduction from baseline through week 16 (data censored at rescue/retreatment) was 7.2, 7.4, 8.1, and 9.5 mm Hg with the 6, 10, 15, and 20 µg dose strengths of BimSR and 8.4 mm Hg in pooled fellow eyes. BimSR controlled IOP without rescue/retreatment in 99%, 91%, 65%, and 41% of study eyes up to 4 weeks, 16 weeks, 7.5 months, and 12 months, respectively (Figure). At month 12, mean IOP reduction from baseline in study eyes ranged from 5.4 mm Hg (6 µg BimSR) to 9.0 mm Hg (20 µg BimSR) vs 8.2 mm Hg in pooled fellow eyes (data censored at rescue/retreatment). Conjunctival hyperemia was the most common ocular AE; in study eyes, it usually occurred within 2 days after the injection procedure and was transient. Conjunctival hyperemia with onset more than 2 days after the injection procedure was more common with topical bim than BimSR (21.3% vs 9.3% of eyes). Eyelash growth was reported in 5 (6.7%) fellow eyes and no study eyes.
All BimSR dose strengths were comparable with topical bim in overall IOP reduction through week 16. A single dose of BimSR controlled IOP up to 12 months in 41% of patients. BimSR was well tolerated; most AEs occurred soon after the injection procedure and were transient. The results support further clinical development of BimSR, and phase 3 trials are in progress.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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