SpyGlass Pharma reported 12-month results from its phase 1/2 trial evaluating the Bimatoprost Drug Pad-IOL system (BIM-IOL system) in patients with open-angle glaucoma or ocular hypertension undergoing cataract surgery. In 104 patients randomized to receive either 78 mcg or 39 mcg BIM-IOL or a monofocal IOL with topical timolol, the implant achieved mean intraocular pressure (IOP) reductions of 34% and 42% in the 2 dose groups, comparable to the 35% reduction in the control group.

Nearly all patients receiving the BIM-IOL System were free from topical IOP-lowering medications at 12 months, and all evaluable patients reached 20/32 or better best-corrected distance visual acuity. Adverse event rates were similar across groups, with no serious ocular events reported.

Earlier this year, SpyGlass reported that it had randomized the first patients in a pair of registrational phase 3 clinical trials evaluating the BIM-IOL system. The trials, SGP-005 (Rhine) and SGP-006 (Rhone), are prospective, multicenter, randomized, masked, and controlled studies that together are expected to enroll approximately 800 participants. Each study will compare the BIM-IOL System with a standard commercial IOL combined with twice-daily topical timolol. Co-primary endpoints include time-matched change in mean IOP from baseline and the proportion of patients achieving best-corrected distance visual acuity of 20/40 or better. Participants will be followed for up to 36 months to assess long-term safety, efficacy, and durability. GP