SpyGlass Pharma, Inc.

BIM-IOL System Program Highlights

12-Month Phase 1/2 Data of BIM-IOL System. In March 2026, SpyGlass Pharma announced positive topline results from its Phase 1/2 trial of the BIM-IOL System, to lower IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract. The trial compared BIM-IOL System at the intended commercial dose of 78-mcg (N=51), and 39-mcg (N=23) compared to a physician's choice of commercially available monofocal IOLs from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eyedrops as the control group (N=30).

For SpyGlass Pharma’s intended commercial dose of 78-mcg, patients receiving the BIM-IOL System achieved robust clinical improvement:

•A mean, time-matched IOP reduction from baseline of 34%.

•98% of evaluable BIM-IOL patients were free from all topical IOP-lowering medications.

•100% of evaluable patients achieved 20/32 or better best corrected distance visual acuity (BCDVA).

•Mean BCDVA equivalent to 20/20 vision (86 letters), demonstrating a vision performance profile in line with the state-of-the-art IOLs in the control group.

•The BIM-IOL System was well tolerated and exhibited a safety profile comparable to routine cataract surgery, with no serious adverse events observed.

SpyGlass Pharma anticipates presenting additional Phase 1/2 trial results at a future medical meeting.

First Surgeries Completed in Parallel Phase 3 BIM-IOL System Trials. The two registrational Phase 3 trials, SGP-005 and SGP-006, are designed to demonstrate non-inferiority of the BIM-IOL System to a state-of-the-art commercial IOL with twice-daily topical timolol. SpyGlass Pharma continues to expect that both trials will complete enrollment in 2027.