6-month data from first-in-human trials shows promise for bimatoprost-eluting IOL

Today, SpyGlass Pharma released 6-month data from a first-in-human trial investigating a proprietary drug delivery platform, which consists of a single-piece hydrophobic acrylic IOL and bimatoprost-eluting pads attached to the haptics. The results indicated that the drug delivery platform lowered intraocular pressure (IOP) significantly in patients with glaucoma or ocular hypertension. The data was presented at Glaucoma 360 New Horizons Forum in San Francisco, CA, in a presentation by Malik Y. Kahook, MD, cofounder, president and executive chairman of the board at SpyGlass Pharma.

The first-in-human feasibility trial consisted of 23 patients, who were randomized to receive one of three doses of bimatoprost via the SpyGlass platform following cataract extraction. At 6 month followup, the mean reduction in IOP across all groups was 45% with no need for additional therapy. Visual outcomes were comparable to those achieved with commercially available IOLs, and no significant adverse events were reported.

“We’ve known for decades that patient adherence to daily drop regimens is an impediment to treating ophthalmic diseases,” said Kahook. “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 device is implanted into the capsular bag during routine cataract surgery. It is designed to deliver bimatoprost therapy to lower IOP in patients with glaucoma and ocular hypertension. Thanks to its eluting design, the device will deliver the drug for up to 3 years.

“For decades, eye doctors have desired a way to help their glaucoma patients adhere to daily drop regimens to preserve vision,” said Patrick Mooney, Chief Executive Officer of SpyGlass Pharma. “These compelling results further demonstrate the SpyGlass drug delivery platform shows great promise for addressing this important unmet need in a meaningful way for patients. By offering a long-term drug delivery option, at the time patients are already scheduled for cataract surgery, we have a significant opportunity to revolutionize the care and management of patients living with chronic eye conditions."

“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,” continued Kahook. “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.”

“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,” continued Mooney. “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.”

SpyGlass intends to submit an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) for their drug delivery platform. Following clearance, they plan to begin enrollment for a U.S. Phase 1/2 combined clinical trial later in 2023. The company also hopes to explore use of the drug delivery platform to treat a variety of ophthalmic conditions, such as chronic uveitis and macular degeneration.