SpyGlass Pharma randomizes first patients in 2 phase 3 clinical trials of the BIM-IOL System

SpyGlass Pharma has randomized the first patients in its 2 registrational phase 3 clinical trials of the Bimatoprost Drug Pad-IOL System (BIM-IOL System) for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).¹

The BIM-IOL System consists of 2 non-bioerodible drug pads attached to the optic-haptic junction of a monofocal intraocular lens (IOL), which is implanted as part of routine cataract surgery. The pads release bimatoprost directly into the aqueous humor for over 3 years and are positioned outside the visual axis, allowing for unobstructed vision.²

According to SpyGlass, only 33% of surgeons routinely (at least 2 times a month) perform MIGS to reduce IOP; the BIM-IOL System allows the remaining percentage of cataract surgeons to treat elevated IOP when performing routine cataract surgery.²

Patrick Mooney, CEO of SpyGlass Pharma, commented on the trial in a press release from the company, saying, “Today’s exciting milestone brings us one step closer to offering the roughly 10,000 cataract surgeons—including the two-thirds who do not routinely perform minimally invasive glaucoma surgery—the promise of seamlessly integrating sustained bimatoprost drug delivery into cataract surgery. Backed by robust clinical data and an optimized Phase III trial design that builds on learnings from our earlier studies, we believe SpyGlass Pharma’s BIM-IOL System is well-positioned to advance through clinical development for potential commercial approval.”

The phase 3 program consists of 2 prospective, multicenter, randomized, masked, controlled clinical trials, SGP-005 and SGP-006, evaluating the efficacy and safety of the BIM-IOL System in patients with OAG or OHT undergoing cataract surgery. According to the company, each trial is expected to enroll approximately 400 patients each. The trials are designed to demonstrate non-inferiority of the BIM-IOL System to a standard of care of commercial IOLs with twice-daily administration of timolol eye drops. Co-primary endpoints for the 2 trials are the time-matched change in mean IOP from baseline, as well as the proportion of patients achieving best corrected distance visual acuity (BCDVA) of 20/40 or better. Patients will be monitored for up to 36 months to evaluate long-term safety, efficacy, and durability.¹

Fiaz Zaman, MD, FACS, ophthalmologist at Houston Eye Associates and an investigator in the phase 1/2 trial of the BIM-IOL System, commented, “As an investigator in the phase I/II clinical trial, I’ve witnessed firsthand how the BIM-IOL System can eliminate the need for drops by providing sustained IOP control in patients with OAG or OHT.”

Data from the phase 1/2 trial showed that mean IOP was reduced by 36-37% and that 97% of treated patients were off topical drops. Additionally, 100% of patients had a BCDVA of ≥20/40 and a mean BCDVA of 20/20.

References:

1. SpyGlass Pharma Announces First Patients Randomized in SGP-005 and SGP-006, Two Registrational Phase III Clinical Trials of Its Novel BIM-IOL System. Published January 20, 2026. Accessed January 20, 2026. https://www.globenewswire.com/news-release/2026/01/20/3221657/0/en/SpyGlass-Pharma-Announces-First-Patients-Randomized-in-SGP-005-and-SGP-006-Two-Registrational-Phase-III-Clinical-Trials-of-Its-Novel-BIM-IOL-System.html

2. The SpyGlass BIM-IOL System. SpyGlass Pharma. Accessed January 20, 2026. https://www.spyglasspharma.com/our-technology/