SpyGlass Pharma, announced that the first patients have been randomized in two registrational phase 3 clinical trials evaluating its lead product candidate, the Bimatoprost Drug Pad–Intraocular Lens System (BIM-IOL System). The studies are designed to assess the safety and efficacy of the BIM-IOL System for lowering IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) undergoing cataract surgery.

The BIM-IOL System is SpyGlass Pharma’s lead product candidate and features proprietary, non-bioerodible drug pads attached to an intraocular lens implanted during routine cataract surgery. The system is designed to deliver consistent, sustained levels of bimatoprost over a 3-year period to reduce elevated IOP in patients with OAG or OHT.

SpyGlass Pharma’s phase 3 clinical program consists of two prospective, multicenter, randomized, masked, controlled trials—SGP-005 and SGP-006—evaluating the BIM-IOL System in patients with OAG or OHT undergoing cataract surgery. Each trial is expected to enroll approximately 400 participants.

The studies are designed to demonstrate noninferiority of the BIM-IOL System compared with a standard-of-care commercial IOL combined with twice-daily timolol eye drops. Co-primary endpoints include time-matched change in mean IOP from baseline and the proportion of patients achieving best corrected distance visual acuity (BCDVA) of 20/40 or better. Secondary measures include change in mean IOP, time to postoperative initiation of IOP-lowering medications, and the number of IOP-lowering medications introduced after surgery. Participants will be followed for up to 36 months to assess long-term safety, efficacy, and durability.

“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,” said Patrick Mooney, Chief Executive Officer of SpyGlass Pharma. “Backed by robust clinical data and an optimized Phase III trial design that builds on learnings from our earlier studies, we believe the BIM-IOL System is well-positioned to advance through clinical development for potential commercial approval.”

In addition to initiating the two registrational phase 3 trials, SpyGlass continues long-term follow-up of patients enrolled in its phase 1/2 study.