SpyGlass Pharma has randomized the first patients in 2 registrational phase 3 clinical trials evaluating its Bimatoprost Drug Pad-IOL (BIM-IOL) system, a sustained drug-delivery intraocular lens (IOL) designed to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension undergoing cataract surgery.

The trials, SGP-005 (Rhine) and SGP-006 (Rhone), are prospective, multicenter, randomized, masked, and controlled studies that together are expected to enroll approximately 800 participants. Each study will compare the BIM-IOL System with a standard commercial IOL combined with twice-daily topical timolol. Co-primary endpoints include time-matched change in mean IOP from baseline and the proportion of patients achieving best-corrected distance visual acuity of 20/40 or better. Participants will be followed for up to 36 months to assess long-term safety, efficacy, and durability.

The BIM-IOL System incorporates non-bioerodible drug pads affixed to an IOL and is designed to deliver bimatoprost continuously for up to 3 years following implantation during routine cataract surgery. Company executives emphasized that the approach is intended to address adherence challenges associated with topical therapy, particularly among cataract patients with coexisting glaucoma or ocular hypertension.

In a press release, SpyGlass said it plans to continue long-term follow-up from its earlier phase 1/2 study while advancing the phase 3 program toward potential regulatory submission. GP