Senju Pharmaceutical and Novaliq have closed a licence agreement for NOV03 (perfluorohexyloctane ophthalmic solution) to treat dry eye disease in Japan.

The agreement covers rights for the development, manufacture and commercialisation of NOV03 in the country.

NOV03 is the first and only water-free and preservative-free prescription treatment for dry eye disease, and targets the evaporation of tears by forming a monolayer at the tear film’s air-liquid interface.

Senju Pharmaceutical president Shuhei Yoshida stated: “We are thrilled to collaborate with Novaliq as a pioneer for cutting-edge water-free eye drop technology.

“On the basis of the very unique features and unparalleled clinical data of NOV03, we strongly believe that it will provide huge clinical benefits to Japanese patients.”

The therapy has shown efficacy and safety in trials for patients with a history of dry eye disease and clinical Meibomian gland dysfunction.

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Novaliq will receive upfront and milestone payments upon achieving regulatory and sales milestones, along with royalties on NOV03 net sales in Japan.

Novaliq CEO Dr Christian Roesky stated: “NOV03 offers a new and unique mode of action and is clinically validated.

“Its safety and efficacy have been demonstrated in numerous studies in Europe, the United States and China. With approximately ten 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.”

Novaliq has also received US Food and Drug Administration approval for VEVYE (cyclosporine ophthalmic solution) 0.1% to treat dry eye disease.