Key Takeaways

  • SpyGlass Pharma reported positive 12-month phase 1/2 results showing the BIM-IOL System produced sustained iIOP reductions of 34%-42% in patients with glaucoma or ocular hypertension undergoing cataract surgery

  • Nearly all treated patients remained free from topical glaucoma medications at 1 year

  • The drug-eluting IOL also delivered strong visual outcomes and a favorable safety profile

SpyGlass Pharma announced positive 12-month results from its phase 1/2 clinical trial evaluating the Bimatoprost Drug Pad–Intraocular Lens System (BIM-IOL System). The investigational device is designed to reduce elevated IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) undergoing cataract surgery.

The study results demonstrated sustained IOP reduction, strong visual outcomes, and the ability for most patients to remain free of topical glaucoma medications 1 year after treatment.

A total of 104 patients were randomized in a 2:1:1 ratio to receive either the 78 mcg BIM-IOL System (n=51), the 39 mcg BIM-IOL System (n=23)—both with daily artificial tears—or a commercially available monofocal IOL with twice-daily timolol eye drops as the control group (n=30).

At 12 months, the BIM-IOL System produced meaningful reductions in IOP across both dose groups. Evaluable patients experienced:

  • 34% reduction in mean IOP from baseline in the 78 mcg group

  • 42% reduction in mean IOP from baseline in the 39 mcg group

  • 35% reduction in the control group at the 8 a.m. measurement

Results were consistent at the 10 am timepoint.

Importantly, the vast majority of patients treated with the device did not require additional glaucoma medications. 98% of evaluable patients (48 of 49) in the 78 mcg group and 96% (22 of 23) in the 39 mcg group remained free from topical IOP-lowering medications.

Visual performance remained strong among patients treated with the system. Among 72 evaluable patients, all achieved 20/32 or better best corrected distance visual acuity (BCDVA), with a mean score of 86 letters, equivalent to approximately 20/20 vision.

Safety outcomes were comparable across treatment arms. Adverse event rates were 41.2% in the 78 mcg group, 43.5% in the 39 mcg group, and 36.7% in the control group, with no serious ocular adverse events reported.

“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,” said Malik Kahook, MD, chief medical officer and executive chair of the board of SpyGlass Pharma.

He noted the findings build on previously reported 3-year first-in-human data.

SpyGlass CEO Patrick Mooney said the results reinforce the company’s confidence in the technology as it moves toward late-stage clinical development.

“This readout clearly demonstrates the potential for SpyGlass technology to have a life-changing impact on patients, while being accessible to 100% of cataract surgeons,” Mr. Mooney said. “We’re now in a category of our own in demonstrating our ability to eliminate topical IOP-lowering medications for the vast majority of patients, while delivering the same high-quality vision that patients and surgeons expect from state-of-the-art IOLs.”

The company is currently advancing two pivotal phase 3 registrational trials evaluating the 78 mcg dose of the BIM-IOL System. In January 2026, SpyGlass announced that the first patients were randomized in these studies. The trials largely mirror the phase 1/2 design with minor modifications intended to improve consistency across treatment arms.

The BIM-IOL System integrates non-bioerodible drug pads containing bimatoprost onto an IOL. The system is designed to deliver multiple years of sustained bimatoprost therapy, potentially addressing one of the biggest challenges in glaucoma management: long-term adherence to daily eye drops.