SGP News & Events

SpyGlass Pharma announced that the American Medical Association's CPT Editorial Panel approved a new add-on Category III CPT code for attachment and insertion of intraocular lens prosthesis-mounted drug-eluting implant, based on the application submitted for the Bimatoprost Drug Pad-IOL System, in conjunction with established Category I cataract surgery procedure codes. "The approved Category III CPT code for attachment and insertion of the BIM-IOL System in conjunction with routine cataract surgery is an exciting moment in our path to product commercialization and reimbursement upon FDA approval," said Patrick Mooney, CEO of SpyGlass Pharma.

SpyGlass Pharma announced positive 12-month results from the Phase 1/2 trial evaluating its lead product candidate, the Bimatoprost Drug Pad-IOL System, BIM-IOL System, for the treatment of elevated intraocular pressure in patients previously diagnosed with open-angle glaucoma or ocular hypertension and a concomitant cataract. A total of 104 patients were randomized 2:1:1 to receive the 78 mcg BIM-IOL System and 39 mcg BIM-IOL System with daily administration of artificial tear drops, or a commercially available monofocal IOL from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eye drops as the control group. At 12 months, the BIM-IOL System achieved: Evaluable patients achieved a 34% and 42% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 35% reduction in the control group at 8 a.m. Results were similar at the 10 a.m. timepoint. 98% of evaluable patients in the 78-mcg dose group and 96% of evaluable patients in the 39-mcg dose group were free from all topical IOP-lowering medications. Evaluable patients demonstrated vision improvement, 100% reaching 20/32 or better best corrected distance visual acuity and mean BCDVA of 86 letters. Adverse event rates were similar across the 78-mcg, 39-mcg, and control groups. No serious ocular AEs were observed

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