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Trial Okayed for Glaucoma Treatment Implant

Fundus photograph

Fundus photograph of a healthy right eye (OptometrusPrime, Wikimedia Commons)

5 Apr. 2023. A developer of treatments for eye diseases says it received clearance from FDA to begin a clinical trial of a sustained-release implant therapy for glaucoma. Perfuse Therapeutics in San Francisco says the Food and Drug Administration yesterday granted its investigational new drug application for the company’s lead product code-named PER-001.

Glaucoma is an eye disease that damages the optic nerve over time leading to progressive loss of vision. The disorder often starts gradually with few if any early symptoms, but as glaucoma advances loss of peripheral vision and blind spots occur, often leading to complete vision loss. Some 3 million people in the U.S. have glaucoma, with open-angle glaucoma the most common form of the disease. People of African or Hispanic backgrounds in the U.S. appear more likely to develop glaucoma at earlier ages. Treatments such as eye drops or laser surgery are more effective at limiting progression of glaucoma in its early stages.

Perfuse Therapeutics says PER-001 is designed to block overactive signals in the eyes from endothelin, an ubiquitous protein found throughout the body to help regulate blood flow. In excess amounts, however, endothelin can cause constriction of blood vessels leading to cell damage and death. In the eyes, excess endothelin signaling can increase internal pressure resulting in damage to cells in the retina and optic nerve. Thus, limiting those signals is believed to relieve pressure within the eye and protect against further cell damage.

Increases blood flow to optic nerve cells

The company says PER-001 is a small molecule endothelin inhibitor that blocks receptors of that protein in the eye. Perfuse Therapeutics formulates PER-001 as a four millimeter biodegradable cylinder surgically implanted into the back of the eye. The company says the implant is designed to release its active ingredients over six months. In a paper presented at an Association for Research in Vision and Ophthalmology meeting in May 2022, researchers reported on tests with lab monkeys induced with glaucoma that show PER-001 increases blood flow to recipients’ optic nerve cells.

Perfuse Therapeutics says FDA approved its investigational new drug or IND application yesterday that provides authorization to proceed with an early- and mid-stage clinical trial of PER-001. The company says the trial will begin with an assessment of PER-001’s safety and tolerability in people with advanced cases of glaucoma. The second part of the trial is expected to test PER-001 given in two doses against a sham implant in people with progressing glaucoma, evaluating the treatment’s safety, tolerability, and chemical activity in the eyes.

The company says glaucoma is the first of several eye disorders it plans to address with PER-001. “The absence of a safe and effective treatment of ischemia in the retina,” says Perfuse Therapeutics CEO and founder Sevgi Gurkan in a company statement, “represents a significant unmet medical need and we plan to evaluate PER-001 intravitreal implant in other retinal diseases driven by ischemia including diabetic retinopathy, dry age-related macular degeneration, and retinal vein occlusion.”

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