Bausch Health Licenses Novaliq’s Investigational Treatment for Dry Eye Disease

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LAVAL, Quebec, and HEIDELBERG, Germany—Bausch Health Companies Inc.  (NYSE/TSX: BHC) and Bausch + Lomb, its leading global eye health business, and Novaliq GmbH, a pharmaceutical company focused on ocular therapeutics, announced late last week a licensing agreement for an investigational dry eye treatment. Bausch Health has acquired an exclusive license for the sale and development in the U.S. and Canada of the investigational treatment NOV03 (perfluorohexyloctane), a first-in-class investigational drug with a novel mechanism of action to treat dry eye disease (DED) associated with Meibomian gland dysfunction (MGD), according to the joint announcement.

NOV03 is a proprietary water-free, preservative-free solution based on Novaliq’s patented EyeSol technology, according to the announcement. DED is a chronic and serious disease of the ocular surface that can negatively impact quality of life.

Under the terms of the licensing agreement, Novaliq is eligible to receive upfront and milestone payments based on regulatory and commercialization milestones, and sales royalties based on annual net sales of NOV03 in the U.S. and Canada, the announcement noted.

In a Phase 2 study, NOV03 met its primary sign endpoint of improvement of total corneal fluorescein staining over control at eight weeks with high statistical significance. In addition, NOV03 showed statistically significant and clinically meaningful improvement in a variety of symptoms over the entire duration of the trial. A Phase 3 study is underway for NOV03, and Bausch Health anticipates starting an additional Phase 3 study in 2020, the announcement noted.

“Bausch Health remains focused on boosting our core businesses, and the addition of this investigational treatment for dry eye disease will help build upon our strong Bausch + Lomb portfolio of integrated eye health products,” Bausch Health chairman and chief executive officer Joseph C. Papa said in the announcement. “It is estimated that more than 16 million patients in the U.S. are diagnosed with dry eye disease, and if approved, NOV03 will be the first pharmaceutical therapy available for patients in the U.S. suffering from dry eye disease with Meibomian gland dysfunction.”