Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 For the Treatment of Dry Eye Disease in Japan

Senju Pharmaceutical and Novaliq have enteed into a license agreement for NOV03 (perfluorohexyloctane ophthalmic solution) for the treatment of dry eye disease in Japan.

Financial terms of the deal were not disclosed. 

Senju Pharmaceutical acquires the rights in Japan to develop, manufacture, and commercialize NOV03, the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear evaporation.

“We are thrilled to collaborate with Novaliq as a pioneer for cutting edge water-free eye drop technology. On the basis of very unique features and unparalleled clinical data of NOV03, we strongly believe that it will provide huge clinical benefits to Japanese patients," Shuhei Yoshida, President of Senju Pharmaceutical, said in a company news release.

NOV03 is a first-in-class, preservative-free treatment for signs and symptoms of dry eye disease. Its unique mode of action directly targets tear evaporation by forming a monolayer at the air-liquid interface of the tear film. NOV03 has demonstrated safety and efficacy in the indication in multiple, adequately controlled studies in patients with a history of dry eye disease and clinical signs of Meibomian gland dysfunction.

“We are proud to partner with Senju Pharmaceutical, a leading ophthalmic company in Japan, to bring NOV03 to patients in Japan”, said Dr. Christian Roesky, CEO, Novaliq. “NOV03 offers a new and unique mode of action and is clinically validated. Its safety and efficacy has been demonstrated in numerous studies in Europe, United States and China. With approximately 10 million units sold in Europe and Australia since its launch in 2015, our water-free EyeSol technology is proven to be safe and well accepted."

Under the terms of the license agreement, Novaliq is eligible to receive upfront and milestone payments contingent upon the achievement of regulatory and sales milestones as well as royalties on net sales of NOV03 in Japan.

Last month, the drug received FDA approval in the US for the treatment of the signs and symptoms of dry eye disease (DED). It is the first and only FDA-approved treatment for DED that directly targets tear evaporation.