SpyGlass Pharma reports positive 12-month phase I/II results for BIM-IOL System in glaucoma and ocular hypertension

SpyGlass Pharma has released positive 12-month results from its phase I/II trial of its Bimatoprost Drug Pad-IOL System (BIM-IOL System) for the treatment of elevated intraocular pressure (IOP) in patients previously diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract.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

The phase I/II trial is a prospective, multicenter, randomized, double-masked, controlled clinical trial. Patients (n=104) were randomized 2:1:1 to receive the 78 mcg BIM-IOL System (n=51) with daily administration of artificial tear drops, the 39 mcg BIM-IOL System (n=23) with daily administration of artificial tear drops, or a commercially available monofocal IOL with twice-daily administration of timolol eye drops as the control group (n=30). Commercially available IOLs included available monofocal IOLs from Alcon, Bausch + Lomb or Johnson & Johnson

The primary endpoint of the trial was the mean reduction of IOP from baseline at 2 time points for each follow-up visit at 2 weeks, 6 weeks, and 3 months.

According to the company, patients achieved a 34% and 42% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 35% reduction in the control group. Additionally, 98% of patients in the 78-mcg dose group and 96% of evaluable patients in the 39-mcg dose group were free from all topical IOP-lowering medications.

All observable patients (n=72) demonstrated vision improvement according to the company, with 100% reaching 20/32 or better best corrected distance visual acuity (BCDVA) and a mean BCDVA of 86 letters (equivalent to 20/20 vision).

Malik Kahook, MD, chief medical officer and executive chair of the board of SpyGlass Pharma, commented on the results, saying, “The 12-month results demonstrate the potential for the BIM-IOL System to address the key challenge of long-term adherence to ophthalmic treatments, delivering sustained IOP reduction and improved visual performance while eliminating the need for topical drops. These positive findings from a multicenter, randomized, controlled clinical trial reinforce our previously released 3-year first-in-human data.”

Recently, SpyGlass randomized the first patients in its 2 registrational phase 3 clinical trials of the BIM-IOL System.³

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.

The company plans to work with the FDA to advance the program through 505(b)(2) New Drug Application (NDA) submission and potential commercial approval.

References:

1. SpyGlass Pharma Announces Positive Topline 12-Month Phase 1/2 Trial Results for Its Innovative BIM-IOL System. Published March 9, 2026. Accessed March 10, 2026. https://www.globenewswire.com/news-release/2026/03/09/3251760/0/en/SpyGlass-Pharma-Announces-Positive-Topline-12-Month-Phase-1-2-Trial-Results-for-Its-Innovative-BIM-IOL-System.html

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

3. Harp MD. SpyGlass Pharma randomizes first patients in 2 phase 3 clinical trials of the BIM-IOL System. Published January 20. 2026. Accessed March 10, 2026. https://www.ophthalmologytimes.com/view/spyglass-pharma-randomizes-first-patients-in-2-phase-3-clinical-trials-of-the-bim-iol-system