SpyGlass Pharma releases positive data from 2 trials of Bimatoprost Drug Pad-IOL System

SpyGlass Pharma has released positive data from 2 trials of its lead candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), for the treatment of elevated IOP in patients with mild-to-moderate open-angle glaucoma (OAG) or ocular hypertension (OHT).

According to the company, the BIM-IOL System features novel, proprietary non-bioerodible drug pads attached to its IOL and was designed to be implanted during routine cataract surgery to reduce elevated intraocular pressure (IOP) in patients who have either OAG or OHT. It is designed to consistently deliver multiple years of bimatoprost.

Jeffrey Kammer, MD, associate professor of ophthalmology at Vanderbilt University Medical Center and an investigator in the phase I/II trial, commented, "The implantation procedure during routine cataract surgery is straightforward, and the three-month IOP reduction results and improved visual performance are highly compelling. I am excited to continue to work with SpyGlass to monitor longer-term results of the BIM-IOL System.”

The 2 trials were a 36-month first-in-human, single-center, prospective trial evaluating the BIM-IOL System for the treatment of elevated IOP in patients with OAG or OHT undergoing routine cataract surgery. In the trial, 23 patients were sequentially assigned 1:1:1 across 3 BIM-IOL System dosage groups.

As well as a phase I/II, prospective, multicenter, randomized, double-masked, controlled clinical trial evaluating the safety and efficacy of the innovative BIM-IOL System in patients with OAG or OHT undergoing cataract surgery. A total of 104 patients were randomized 2:1:1 to receive either the 78 mcg BIM-IOL System (n=51) or the 39 mcg BIM-IOL System (n=23), both 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).

The primary endpoint of the phase I/II trial was the mean IOP reduction from baseline at 2-week, 6-week, and 3-month timepoints following implantation of the BIM-IOL System delivering bimatoprost at 2 dose levels, 78 mcg and 39 mcg.

The first-in-human trial showed a 37% reduction in mean IOP in patients across all dose groups from 25.1 ± 2.5 mmHg at baseline post-washout to 15.9 ± 2.7 mmHg. Additionally, 95% of patients in the trial were off all topical IOP-lowering medications, and 100% of patients achieved 20/30 or better best corrected distance visual acuity (BCDVA).

Malik Kahook, MD, co-founder and president of SpyGlass Pharma, commented on the first-in-human results in a release, saying, “The FIH results demonstrate that the BIM-IOL System can deliver sustained IOP reduction, drop-free outcomes, and strong visual performance for 3 years.”

Results from the phase I/II trial showed that patients receiving the BIM-IOL System achieved a mean reduction in IOP comparable to the control group. The control received a commercially available monofocal intraocular lens (IOL) with twice-daily timolol eye drops. At 3 months it was shown that patients achieved a 37% and 36% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 37% reduction in the control group.

Additionally, 98% of patients in the 78-mcg dose group and 96% of patients in the 39-mcg dose group were free from all topical IOP-lowering medications. The results showed that patients demonstrated vision improvement as well, reaching 20/40 or better BCDVA and a mean BCDVA of 85 to 86 letters.

The company noted it plans to work with the FDA to advance the program through initiation of phase III clinical trials.

References:

1. SpyGlass Pharma Announces Positive 36-Month First-in-Human and 3-Month Phase I/II Trial Results for Its Novel BIM-IOL System. Published November 10, 2025. Accessed November 10, 2025. https://www.globenewswire.com/news-release/2025/11/10/3184483/0/en/SpyGlass-Pharma-Announces-Positive-36-Month-First-in-Human-and-3-Month-Phase-I-II-Trial-Results-for-Its-Novel-BIM-IOL-System.html