Published in Pipeline

SpyGlass Pharma unveils 6-month data from the first-in-human trial of its drug delivery platform for chronic eye conditions

SpyGlass Pharma, a privately held ophthalmic therapeutics company, released 6-month data from a first-in-human glaucoma treatment trial showing that its breakthrough drug delivery platform continues to demonstrate significant intraocular pressure (IOP) lowering in patients with glaucoma or ocular hypertension.

The data were showcased during an oral presentation by Malik Y. Kahook MD, at the Glaucoma 360 New Horizons Forum today in San Francisco.

“We are very pleased to share updated results from our First-in-Human clinical trial. We continue to see impressive performance with 45% mean IOP reduction across all treatment groups 6 months after implantation of the SpyGlass drug delivery platform at the time of cataract surgery,” said Malik Y. Kahook, MD, co-founder, president and executive chairman of the Board at SpyGlass Pharma. “We’ve known for decades that patient adherence to daily drop regimens is an impediment to treating ophthalmic diseases. These data give a clear signal that the SpyGlass drug delivery system is a breakthrough platform technology with real potential to disrupt the way our most effective therapies are administered long-term. The SpyGlass drug delivery platform with bimatoprost is designed to enable every cataract surgeon the ability to provide unprecedented, multi-year glaucoma therapy at the time of routine cataract surgery. This is a potential game changer for ophthalmic patients globally. Every cataract surgeon will be able to use their existing intraocular lens (IOL) implantation technique to both improve vision due to cataracts and deliver multiple years of bimatoprost therapy for patients who also have glaucoma.”

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 six months, mean reduction in IOP across all groups was 45%, without the need for additional therapy. No significant adverse events were reported, and visual outcomes were similar to those achieved with commercially available IOLs.

“We continue to be excited about the possibilities to improve the lives of patients. Our vision is to enable all cataract surgeons to restore sight for patients living with cataracts, and to provide years of IOP-lowering therapy within the same procedure,” said Patrick Mooney, CEO of SpyGlass Pharma. “Approximately 1 in 5 patients treated for cataracts in the United States and Western Europe also suffer from glaucoma or ocular hypertension. The SpyGlass platform will empower cataract surgeons with the ability to solve patient adherence challenges associated with chronic use of topical therapy without any significant changes to their standard cataract procedure. The SpyGlass team is busily preparing our Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA). Once cleared, we intend to enroll patients in a US Phase 1/2 combined clinical trial later this year. 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 potentially treat a variety of eye conditions including chronic uveitis and macular degeneration.”