SpyGlass Pharma Presents 3-Month Data from the First-In-Human Trial of Its Drug Delivery Platform for Chronic Eye Conditions
SpyGlass Pharma announced 3-month data from a first-in-human glaucoma treatment trial showing that its breakthrough drug delivery platform lowered IOP in patients with open-angle glaucoma or ocular hypertension. The data were showcased during an oral presentation at the Eyecelerator innovation meeting at the American Academy of Ophthalmology annual meeting (AAO 2022) in Chicago.
“We are pleased to share the 3-month results from our first-in-human clinical trial. The SpyGlass drug delivery platform holds great promise for patients living with glaucoma and other chronic eye conditions,” Malik Y. Kahook, MD, Co-Founder, President and Executive Chairman of the Board at SpyGlass Pharma, said in a company news release. “Our innovative drug delivery platform is designed to enable all cataract surgeons to provide unprecedented multi-year therapy to treat glaucoma and other chronic eye conditions at the time of routine cataract surgery. The initial data are compelling and demonstrate the potential of this new treatment paradigm to significantly improve patient management without compromises.”
The SpyGlass platform, which consists of a single-piece, hydrophobic acrylic IOL and drug-eluting pads securely attached to the haptics of the IOL, is implanted directly into the capsular bag during routine cataract surgery. The lead SpyGlass program is designed to deliver multiple years of bimatoprost therapy to lower IOP in patients with glaucoma or ocular hypertension.
For the first-in-human feasibility trial, 23 patients undergoing cataract extraction were randomized to receive one of three doses of bimatoprost using the SpyGlass platform. After 3 months, mean reduction in IOP across all groups was 45%, and all patients achieved an IOP of 18 mmHg or lower without the need for additional therapy. No significant adverse events were reported, and visual outcomes were similar to those achieved with commercially available IOLs.
“The new 3-month results presented at Eyecelerator highlight the value of the SpyGlass platform for the treatment of chronic eye conditions,” said Robert Cionni, MD, Adjunct Associate Professor at the University of Utah and the John A. Moran Eye Center. “Approximately 20% of cataract procedures each year are performed in patients who also have glaucoma or ocular hypertension. Cataract surgeons are very comfortable with their current procedural techniques. The SpyGlass platform offers unique advantages to other methods; it allows surgeons to maintain their trusted techniques, it does not require new skills to perfect and, most importantly, it finally empowers all eye doctors to ensure patient adherence to therapy over multiple years.”
“We are excited about the possibilities for this first-of-its-kind platform, and we are thrilled to unveil initial data on its use in glaucoma patients undergoing cataract surgery,” said Patrick Mooney, Chief Executive Officer of SpyGlass Pharma. “While our initial program focuses on glaucoma management at the time of cataract surgery, the SpyGlass platform is capable of delivering a number of ophthalmic medications, offering the versatility to treat a variety of eye conditions. Current pipeline projects underway for the SpyGlass platform include its use for delivering post-operative steroids and NSAIDs as well as potentially treating chronic uveitis and macular degeneration.”
Meetings with both the FDA and Centers for Medicare and Medicaid Services have taken place, with clear registration and reimbursement pathways established, according to SpyGlass. The company plans to file an investigational new drug application in the next 6 months and, pending clearance, will begin enrollment of patients in a US phase 1/2 clinical trial in 2023.