Imprimis Pharmaceuticals announced that it has entered into an licensing agreement for the exclusive worldwide rights to Klarity, a patented ophthalmic topical solution and gel technology for patients with dry eye disease (DED). Klarity is designed to protect and rehabilitate the ocular surface following ophthalmic surgery, contact lens wear, or in patients with moderate to severe DED. The Klarity formulation is preservative-free and can be formulated to any viscosity, ranging from a topical drop or gel to a dispersive viscosurgical device.
The technology was developed by Richard L. Lindstrom, MD, a cataract and refractive surgeon, inventor, and consultant to numerous private and public ophthalmic companies. Under the terms of the agreement, Imprimis will pay Dr. Lindstrom an upfront fee, milestone payments, and royalty payments on product sales.
"The company's commercial capabilities in ophthalmology make them the optimal team to bring this unique dry eye technology to market. When the surface of the eye is damaged following ophthalmic surgery, contact lens wear and with moderate and severe dry eye, they must be rehabilitated. There is no other topical drop which has been specifically positioned for this large dry eye market niche. Over-the-counter topical lubricating drops positioned for mild to moderate dry eye can be helpful, but they do not treat the associated edema, free radical formation or have an agent like Chondroitin Sulfate, which can serve as a cell membrane stabilizer. There is clearly a vast and relatively untapped market that could greatly benefit from Klarity's proprietary formulation and function," Dr. Lindstrom said in a company news release.
"We are committed to our vision of delivering innovative and affordable medications to physicians and their patients. This agreement further strengthens our growing ophthalmology portfolio and provides us the opportunity to enter a market with significant growth potential," Mark L. Baum, CEO of Imprimis, said in the news release. "We believe our Klarity formulation has the potential to fill an unmet need in current treatment options for patients with moderate and severe DED and it is a privilege to license this important technology from a good friend of our company and a valued member of our board. The Klarity formulation will be a cornerstone of our new dry eye program which we expect to launch in the second half of 2017. We look forward to competing in the over $2 billion U.S. dry eye market and believe this innovative medication can gain significant traction in the growing DED market."
The Klarity formulation is specifically designed for the treatment of ocular surface pathology associated with ophthalmic surgery, contact lens wear and patients with moderate to severe dry eye. These include the development of epithelial and stromal corneal edema, the presence of increased oxidation agents and free radicals, cellular damage and death, and a significantly irritated eye. The active ingredients include Chondroitin Sulfate, a cell membrane stabilizer, deturgescent agent, free radical scavenger and lubricant. Other ingredients include Dextran and Glycerol, deturgescent agents which also enhance lubrication. Ophthalmologists are familiar with Chondroitin Sulfate through clinical experience with Optisol-GS, Viscoat, and DisCoVisc and the other key ingredients in the Klarity formulation are also well accepted in ophthalmology.