The National Eye Institute of the National Institutes of Health (NIH) has awarded Small Business Innovation Research (SBIR) grant R43-EY037590 to Proteris Biotech, Inc. (PB) to continue preclinical development of an innovative eye drop technology for the treatment of dry eye. The ultimate goal is a new U.S. Food and Drug Administration (FDA)-approved biologic drug.
Dry eye, characterized by inadequate hydration and lubrication of the ocular surface, is a group of disorders that affects ~5 million people over the age of 50 in the USA today. Dry eye is brought on by many situations, including aging, eye surgery, autoimmune conditions, and environmental exposure. Symptoms include pain, burning, itching, redness, sensitivity to light, and other discomfort. If left untreated, severe cases may result in vision loss due to corneal scarring.
The active ingredient of PB’s eye drop is clusterin, a natural protein found in all bodily fluids, including the tears. Clusterin is a molecular chaperone and a matrix metalloproteinase inhibitor. PB and academic collaborators at the University of Southern California’s Keck School of Medicine in Los Angeles and
Boston University’s Chobanian & Avedisian School of Medicine showed in three preclinical models of dry eye that clusterin reduces inflammation, reverses ocular surface damage (epitheliopathy), restores mucous-secreting goblet cells and regenerates corneal nerves.
“At the present time, two FDA-approved small molecules dominate the dry eye market” observes M. Elizabeth Fini, Ph.D., PB’s Chief Scientific Officer. “These drugs are anti-inflammatory because they target T-cells that regulate the immune response, but they are slow to act and they are not consistently effective in improving epitheliopathy. In contrast, clusterin’s anti-inflammatory activity is at least partially due to its ability to directly target epitheliopathy. Clusterin thus acts quickly to protect, seal and heal.”
“The most innovative action of clusterin, however” said Dr. Fini, “is one we only recently discovered, working with our Boston University collaborators in a Sjögren’s disease model of dry eye. We found that treatment with clusterin ophthalmic solution regenerates corneal nerves lost to dry eye.”
The cornea is the most highly innervated organ in the body. Corneal nerves are necessary for sensation, to maintain health of the corneal epithelium and to control tear production by the lacrimal gland. Loss of corneal nerves exacerbates dry eye and can lead to corneal ulceration. The only drug currently approved by the FDA for corneal nerve regeneration is Nerve Growth Factor, approved for the treatment of neurotrophic keratitis.
The mission of the National Institutes of Health’s (NIH) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs is to foster scientific excellence and technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy.
“NIH grant applications are rigorously peer-reviewed in a highly competitive process that focuses on scientific excellence, innovation, and impact”, notes John C. Fini, PB’s Chief Executive Officer. “Award of this third NIH grant to Proteris Biotech provides independent validation of our vision for clusterin as a breakthrough therapeutic.”
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Proteris Biotech, Inc. is a start-up biotechnology company incorporated in Glendale, California, but currently based in Mansfield, Massachusetts. The company platform is therapeutic products that harness the body’s natural response to stress.
Contact: John C. Fini, CEO
Email: johncfini@proterisbiotech.com
Website: www.proterisbiotech.com
This press release was prepared by Proteris Biotech. Its content does not necessarily represent the official views of the National Institutes of Health.