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, which evaluated two dose levels of 78-mcg (N=51), the intended commercial dose, 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). Evaluable patients receiving the BIM-IOL System achieved a time-matched reduction of 34% and 42% in mean IOP from baseline in the high and low 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. Additionally, 98% of evaluable patients (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications 12 months after surgery. The BIM-IOL System demonstrated improved visual performance, in line with the control group with 100% (72 of 72) of trial participants receiving the BIM-IOL System reaching 20/32 or better best corrected distance visual acuity (BCDVA), and mean BCDVA of 86 letters, which is equivalent to 20/20 vision.

The BIM-IOL System was well tolerated and exhibited a safety profile comparable to routine cataract surgery, with no serious ocular adverse events (AEs) observed. SpyGlass Pharma anticipates presenting additional Phase 1/2 trial results at a future medical meeting.

First Patients Randomized and First Surgeries Completed in Phase 3 Trials. In January 2026, SpyGlass Pharma announced that it randomized the first patients in SGP-005 and SGP-006, the Company’s two registrational Phase 3 clinical trials to demonstrate non-inferiority of the BIM-IOL System in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) undergoing cataract surgery compared to a standard of care, commercially available IOL with twice-daily administration of timolol eye drops. The co-primary endpoints are the time-matched change in mean IOP from baseline, as well as the proportion of patients achieving BCDVA of 20/40 or better.

36-Month First-in-Human (FIH) Data of BIM-IOL System. In November 2025, at the Interventional Glaucoma Consortium Meeting, SpyGlass Pharma announced 36-month follow-up data from its FIH study of the BIM-IOL System, demonstrating a 37% reduction in mean IOP across all dose groups and reporting that 95% of patients were off all topical IOP-lowering drops. Additionally, 100% of evaluable patients achieved 20/30 or better BCDVA. No product-related AEs were reported.

Presentation at Premier Interventional Glaucoma Medical Meeting. In February 2026, Dr. Nathan Radcliffe, a seasoned glaucoma and cataract surgeon at the New York Eye Surgery Center and member of SpyGlass Pharma’s medical advisory board, presented data generated to date in the FIH and Phase 1/2 trials of the BIM-IOL System and an overview of SGP-005 and SGP-006’s trial designs at the Glaucoma Innovation Summit (GIS) at the American Glaucoma Society’s 2026 Annual Meeting.