Developing solutions to harness your body's natural protective responses for the prevention and treatment of disease.
Developing solutions to harness your body's natural protective responses for the prevention and treatment of disease.
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 past decade has seen a number of new drugs obtain FDA-approval for the treatment of dry eye, but because dry eye has so many different causes, these drugs do not work for everyone. Protearin™ directly targets ocular surface damage (epitheliopathy) common to all forms of dry eye. Protearin™ acts quickly to protect, seal and heal.
The active ingredient of Protearin™ is clusterin, a natural protein found in all bodily fluids, including the tears.
Clusterin is a molecular chaperone, i.e., a protein that protects other proteins from denaturation and aggregation. Think of a clear egg white that become opaque when cooked. That’s denaturation and aggregation, and it occurs in dry eye.
Clusterin is also a matrix metalloproteinase inhibitor, in particular MMP9, a hallmark of dry eye. Too much MMP9 leads to ocular surface damage. Clusterin prevents MMP9 from going wild.
Proteris Biotech has now shown in three different preclinical models of dry eye that supplementation of clusterin at the ocular surface:
Reduces inflammation.
Seals damage and prevents further damage.
Restores goblet cells that produce mucus needed for high-quality tears.
Regenerates corneal nerves.
The last finding is the most recent, and potentially the most exciting. The cornea is the most highly innervated organ in the body. Corneal nerves are necessary for sensation, to maintain the 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. Nerves are absolutely essential for cornea health.
There is only one drug currently approved by the FDA that promotes corneal nerve regeneration. However, this drug, the active ingredient of which is Nerve Growth Factor, has several drawbacks, the most important being that it also stimulates damaging inflammation.
Preclinical testing make a strong case to use clusterin as a biological drug to prevent or treat, not only dry eye, but also other corneal disorders involving damage to the ocular surface, or other barriers in the eye.
Studies conducted with academic collaborators at the University of Southern California’s Keck School of Medicine in Los Angeles, and more recently at Boston University’s Chobanian & Avedisian School of Medicine, demonstrated the remarkable potential for Protearin™. This positions Protearin™ as the first of its kind platform therapy for dry eye and related conditions.
A potential application for the prevention and treatment of corneal disorders
Born out of the Keck School of Medicine at USC
USC Institute for Genetic Medicine
Born out of the Keck School of Medicine at USC
USC Institute for Genetic Medicine