SpyGlass Pharma has announced compelling 18-month data from its first-in-human study of an innovative intraocular lens (IOL)-mounted drug delivery platform, showing significant improvements in both visual acuity and intraocular pressure (IOP) for patients with glaucoma or ocular hypertension who underwent cataract surgery.
The data, presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in Los Angeles, demonstrated that all patients achieved best-corrected distance visual acuity (BCDVA) of 20/30 or better, with some reaching 20/16 vision. This represents a substantial improvement from baseline measurements of 20/30-20/100.
Significant IOP Reduction Maintained at 18 Months
The single-center, prospective cohort study included 23 patients with visually significant cataracts and concomitant glaucoma or ocular hypertension. All participants received the SpyGlass IOL-based Drug Delivery Platform during cataract surgery.
Mean IOP was reduced from 25.1 ± 2.5 mmHg at baseline (post-washout) to 14.1 ± 2.6 mmHg at 18 months, representing a statistically significant reduction (p<0.0001). Notably, all patients remained off topical IOP-lowering medications throughout the 18-month period.
"In the U.S., 5 million cataract surgeries are performed annually, with 20% occurring in patients who also have increased intraocular pressure caused by open-angle glaucoma or ocular hypertension," said Dr. Malik Kahook, Co-founder of SpyGlass Pharma and professor of ophthalmology at the University of Colorado Anschutz Medical Campus. "Our compelling 18-month results highlight the potential long-term benefits of the SpyGlass Drug Delivery Platform for these patients."
Platform Design and Dosing
The study evaluated three different dosage groups (75 mcg, 150 mcg, and 300 mcg) of bimatoprost delivered through the platform. Researchers found no statistically significant difference in IOP reduction across the three dosage groups, suggesting efficacy across multiple dose levels. Importantly, no product-related adverse events were observed during the study period.
The SpyGlass Drug Delivery Platform is designed to deliver bimatoprost to targeted ocular tissues for up to three years, potentially eliminating the need for daily eye drops in this patient population. The technology combines a monofocal intraocular lens with a mounted sustained-release bimatoprost implant.
Addressing a Significant Unmet Need
The platform aims to address a substantial unmet need in ophthalmology. Approximately one million cataract surgery patients annually also have increased intraocular pressure due to open-angle glaucoma or ocular hypertension. Poor adherence to topical medication regimens remains a significant challenge in managing these conditions.
"We continue to see the SpyGlass Drug Delivery Platform poised to reimagine the treatment paradigm by addressing the unmet need of long-term drug delivery while also utilizing a familiar implantation technique for cataract surgeons," said Patrick Mooney, CEO of SpyGlass Pharma. "This promising dataset bolsters the potential for long-term durability of both visual outcomes and IOP lowering efficacy."
Development Pipeline and Future Plans
SpyGlass Pharma has completed enrollment in a Phase I/II study in the United States to investigate the safety and efficacy of its platform in a larger patient population. The company plans to continue following patients from the first-in-human study, with longer-term data expected in the coming months.
The company is working closely with the U.S. Food and Drug Administration (FDA) to advance the program into Phase III clinical trials with the ultimate goal of commercial approval. If successful, this technology could significantly change the treatment paradigm for patients with both cataracts and glaucoma or ocular hypertension.
The SpyGlass technology was originally developed at the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine before being spun off following Series A funding. The company was co-founded by Dr. Malik Y. Kahook and Glenn Sussman.
Clinical Implications
The dual benefit of improved vision and sustained IOP control without the need for daily medications represents a potentially transformative approach for this patient population. Current standard of care typically requires continued use of topical medications following cataract surgery in patients with glaucoma or ocular hypertension.
If the platform maintains its efficacy and safety profile in larger trials, it could offer a significant quality-of-life improvement for patients while potentially improving treatment adherence and outcomes. The familiar surgical technique required for implantation may also facilitate adoption among cataract surgeons if the product receives regulatory approval.
