Positive Topline Results, Promising Future for Bimatoprost Drug Pad-IOL System, With Fiaz Zaman, MD

On March 9, 2026, SpyGlass Pharma announced positive 12-month results from its phase 1/2 trial of the Bimatoprost Drug Pad-IOL System (BIM-IOL) for the treatment of elevated intraocular pressure (IOP).¹

In an interview with Ophthalmology Times, Fiaz Zaman, MD, an ophthalmologist with Houston Eye Associates and a lead investigator on the trial, discusses the BIM-IOL System’s promising phase 1/2 results – and hints at its pathway towards regulatory approval following the initiation of phase 3 testing.

“The goal of the therapy is to improve patients’ vision with cataract surgery and to treat their glaucoma without them having to put actual medication in their eye themselves,” Zaman said. “The drug pad delivery system will deliver the medicine for the patient, offering to give the patient glaucoma treatment without them having to remember to do something every day.”

The BIM-IOL System is a set of novel, proprietary non-bioerodible drug pads attached to an intraocular lens. The System was designed for implantation during routine cataract surgery to reduce elevated IOP in patients with either open-angle glaucoma (OAG) or ocular hypertension (OHT). The implant consistently delivers multiple years’ worth of bimatoprost, which is a prostaglandin analog.¹

The present observational study included patients diagnosed with mild to moderate OAG or OHT and a planned removal of cataract. Patients were excluded if they had a history of incisional or refractive corneal surgery, pseudoexfoliation, pigmentary glaucoma, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders, among other criteria.²

A total of 104 patients were enrolled in the trial and randomly assigned in a 2:1:1 ratio to either the 78 mcg BIM-IOL System (n = 51) and the 39 mcg BIM-IOL System (n = 23) with daily artificial tear drops or a commercially available monofocal IOL with twice-daily timolol eye drops (n = 30). The primary endpoint of the study was mean IOP reduction from baseline at 2 time points for each follow-up at 2 weeks, 6 weeks, and 3 months. Secondary endpoints included mean IOP reduction from baseline, time to reintroduction and number of IOP-lowering medications, and visual performance improvement, among others.¹

Ultimately, after 12 months, Zaman and colleagues saw evaluable patients achieve a 34% and 42% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to 35% in control. Additionally, 98% of evaluable patients in the 78-mcg dose group and 96% in the 39-mcg dose group were free from all topical IOP-lowering medications.¹

Patients also saw visual improvement, with 100% achieving 20/30 or better best corrected distance visual acuity (BCDVA) and a mean BCDVA of 86 letters. Adverse event rates were similar among all 3 treatment arms, and no serious ocular adverse events were observed.¹

Zaman went on to discuss the promise of this new technology, particularly given its progression to phase 3 trials in January 2026. He also speculated that the BIM-IOL System can and will be applied to various additional conditions and medications, given its comparative efficacy against other, similar implants.

“The bottom line is that we’re just scratching the surface of what this technology can do,” Zaman said. “It’s going to open the door for other opportunities for patients with other disease states, who could get this drug delivery system to help treat their diseases as well.”

Editors’ Note: Zaman is a speaker for Aerie Pharmaceuticals and Allergan.

References

1. SpyGlass Pharma. SpyGlass Pharma Announces Positive Topline 12-Month Phase ½ Trial Results for Its Innovative BIM-IOL System. GlobeNewswire. March 9, 2026. Accessed April 16, 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. SpyGlass Pharma, Inc. Observational Study to Evaluate Long Term Outcomes for Ocular Hypertension and Glaucoma Patients Treated With the SpyGlass Bimatoprost Implant System / IOL Combination. ClinicalTrials.gov Identifier: NCT07154810. Updated September 4, 2025. Accessed April 16, 2026. https://clinicaltrials.gov/study/NCT07154810