Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypert
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A study was done to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10- and 15-?g bimatoprost implant in subjects with open-angle glaucoma (OAG) and ocular hypertension (OHT) after initial and repeated administrations.

Adults with open-angle glaucoma or ocular hypertension in each eye, open iridocorneal angle inferiorly in the study eye and study eye baseline IOP (hour 0; 8 am) of 22–32 mmHg after washout. Study eyes received bimatoprost implant 10 ?g or 15 ?g on day 1 with the administration at weeks 16 and 32, or twice-daily topical timolol maleate 0.5%. Intraocular pressure was measured at hours 0 and 2 at each visit. Primary endpoints were IOP and change from baseline IOP through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD).

Both dose strengths of bimatoprost implant were non-inferior to timolol in IOP lowering after each administration. Mean diurnal IOP was 24.0, 24.2, and 23.9 mmHg at baseline and from 16.5–17.2, 16.5–17.0, and 17.1–17.5 mmHg through week 12 in the 10-?g implant, 15-?g implant, and timolol groups, respectively. The incidence of corneal and inflammatory TEAEs of interest was higher with bimatoprost implant than timolol and highest with the 15-?g dose strength.

Both dose strengths of bimatoprost implant met the primary endpoint of noninferiority to timolol through week 12. One year after 3 administrations, IOP was controlled in most subjects without additional treatment. The risk-benefit assessment favored the 10-?g implant over the 15-?g implant. Ongoing studies are evaluating other administration regimens to reduce the potential for CECD loss. The bimatoprost implant has the potential to improve adherence and reduce the treatment burden in glaucoma.