In a September 2022 press release, eye care therapeutics company Spyglass Pharma, Inc. announced breakthrough data on its experimental drug delivery platform for treating open-angle glaucoma or ocular hypertension.* Their feasibility trial findings were presented at the American Academy of Ophthalmology (AAO) 2022 annual meeting.

Innovative drug delivery

Research has shown that about 40% of people with glaucoma fail to consistently follow their prescribed treatment plan. Forgetfulness and difficulty in applying eye drops are among the most frequently cited reasons. To help overcome such issues, scientists have been researching and developing devices that can be implanted in the eye and release medication for sustained release over long periods. 

Spyglass Pharma’s experimental eye implant device is an acrylic, water-repellant intraocular lens (IOL) that is inserted during routine cataract surgery in place of the clouded natural lens. The device is intended to provide multiple years of bimatoprost treatment to reduce eye pressure in people with glaucoma or ocular hypertension.

Promising early results

Results were promising in the device’s first-in-human trial for testing feasibility. During the trial, 23 people having cataract surgery were randomly given one of three bimatoprost doses with the Spyglass device.

• At three months, the average reduction in eye pressure for all three groups was 45%.
• All participants experienced an eye pressure of 18 mmHg or lower without needing more treatment. (Normal eye pressure is approximately 12 to 22 mmHg.)
• Visual improvement was similar to currently available IOLs.
• No significant side effects were reported.

What it means

Malik Y. Kahook, M.D., Spyglass Pharma’s co-founder, president, and executive chair, was pleased with the three-month outcomes and believes the implant holds “great promise” for glaucoma and other chronic eye disease patients. “The initial data are compelling,” he said, “and demonstrate the potential of this new treatment paradigm to significantly improve patient management without compromises.”

Robert Cionni, M.D., with the University of Utah’s John A. Moran Eye Center, explained that about 20% of yearly cataract procedures involve people with glaucoma or ocular hypertension and that the Spyglass device offers advantages over other surgical methods for cataracts.

Significantly, no new surgical skills are needed. “Most importantly,” said Cionni, “it finally empowers all eye doctors to ensure patient adherence to therapy over multiple years.”

Spyglass is focused on initially using the device in glaucoma patients, but Chief Executive Officer Patrick Mooney noted that it’s capable of delivering medications in a variety of other chronic eye conditions, as well, such as macular degeneration.

Next steps

Spyglass says that “clear registration and reimbursement pathways” have been established after meeting with the U.S. Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services. 

In the next six months, Spyglass intends to file an Investigational New Drug Application with the FDA. If approved, recruitment will begin next year for a U.S.-based Phase I/II clinical trial.

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*Spyglass Pharma. (2022, September 29). SpyGlass Pharma Presents Compelling 3-Month Data from the First-In-Human Trial of Its Innovative Drug Delivery Platform for Chronic Eye Conditions [Press release]. Globe NewsWire. https://www.globenewswire.com/news-release/2022/09/29/2525604/0/en/SpyGlass-Pharma-Presents-Compelling-3-Month-Data-from-the-First-In-Human-Trial-of-Its-Innovative-Drug-Delivery-Platform-for-Chronic-Eye-Conditions.html