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SpyGlass prepares for End of Phase II meeting with the FDA to advance its Drug Delivery platform into Phase III pivotal studies Innovative platform has the potential to enable all cataract surgeons to treat glaucoma during routine cataract procedures
ALISO VIEJO, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- SpyGlass PharmaTM, a privately-held ophthalmic biotechnology company, today announced completion of enrollment in its Phase I/II, randomized, multi-center, controlled clinical trial (NCT06120842 ) evaluating SpyGlass' Drug Delivery Platform in patients with glaucoma or ocular hypertension. The SpyGlass platform is designed to deliver multiple years of bimatoprost to lower intraocular pressure (IOP) and is implanted during routine cataract surgery.
“Chronic eye conditions, such as glaucoma, can lead to vision loss and significantly impact quality of life. That's why SpyGlass is singularly focused on making a difference for those in need,” said Patrick Mooney, SpyGlass Pharma's Chief Executive Officer.“Completing enrollment in this study is an important milestone in our efforts to bring the SpyGlass technology to millions of patients around the world. We look forward to continued engagement with the FDA as we advance our platform toward two large Phase III trials.”
“The SpyGlass technology continues to demonstrate great potential for improving care in glaucoma patients undergoing routine cataract surgery,” said Malik Kahook, M.D., co-founder of SpyGlass PharmaTM.“As the SpyGlass platform is implanted using standard surgical techniques, it could significantly expand the integration of glaucoma treatment into routine cataract procedures. This could enhance adoption across a broad spectrum of surgeons and practices, setting our platform apart from currently available glaucoma interventions.”
Dr. Kahook added,“We are deeply grateful to the investigators and patients whose participation has been essential to advancing this clinical trial. Their trust and commitment have helped bring us closer to delivering a treatment that could significantly enhance care for glaucoma patients worldwide.”
ABOUT SPYGLASS PHARMA
The SpyGlass Drug Delivery Platform with bimatoprost is designed to deliver 3 years of bimatoprost to targeted tissues. SpyGlass will continue to release data from both the first-in-human study, which was recently published with 18-month data, and this Phase I/II study as it becomes available. SpyGlass looks forward to working closely with the U.S. Food and Drug Administration (FDA) to advance the program to commercial approval.
SpyGlass Pharma was co-founded by Dr. Malik Y. Kahook, M.D. and Glenn Sussman. The company is focused on the development of the world's first, IOL-mounted, controlled release drug delivery platform capable of delivering multiple years of therapy. SpyGlass is backed by investors including New Enterprise Associates (NEA), RA Capital, Vensana Capital, Samsara BioCapital and Vertex Ventures HC. The technology was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine and spun off campus post Series A funding.
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