Bausch Health Companies and Novaliq have announced that Bausch Health has acquired an exclusive license for the commercialization and development in the United States 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).
Financial terms of the deal were not disclosed. Under the terms of the licensing agreement, Germany-based 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 United States and Canada.
NOV03 is a proprietary water-free, preservative-free solution based on Novaliq’s patented EyeSol technology. 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 (P<0.001). 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.
“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,” Joseph C. Papa, chairman and CEO of Bausch Health, said in a company news release. “It is estimated that more than 16 million patients in the United States are diagnosed with dry eye disease, and if approved, NOV03 will be the first pharmaceutical therapy available for patients in the United States suffering from dry eye disease with Meibomian gland dysfunction.”
“We are thrilled to partner with Bausch + Lomb who is a leader in the ophthalmic space with a strong commercial footprint in the United States and is also very committed to developing innovative new eye health products,” said Christian Roesky, PhD, CEO of Novaliq. “As part of Bausch + Lomb’s portfolio, we believe that NOV03 will help address the unmet medical need of millions of patients suffering from dry eye disease.”
Bausch Health has the right to pursue development and commercialization of NOV03 for DED and combination products based on NOV03 in additional ophthalmic indications in the United States and Canada. Novaliq will be eligible to receive additional undisclosed milestone payments plus royalties for any resulting combination products.