Novaliq and Laboratoires Théa Announce EU Approval for Vevizye for Dry Eye Disease

Novaliq and Laboratoires Théa announced the European Commission’s approval of Vevizye (ciclosporin 0.1% eye drops solution) for the treatment of moderate to severe dry eye disease (DED) in adults unresponsive to tear substitutes.

Vevizye is based on Novaliq’s proprietary EyeSol water-free technology, making it the only ciclosporin 0.1% eye drops solution without water approved in the European Union. In conjunction with this approval, Théa has acquired the rights to commercialize Vevizye in Europe, as well as selected markets in the Middle East and North Africa (MENA).

Financial terms of the deal were not disclosed. 

“Our partnership with Novaliq highlights our dedication to delivering innovative treatments to all patients. We are looking forward to launching Vevizye to complement our range of non-preserved treatments for dry eye, a disease that has substantial impacts on the quality of life of many patients," Jean-Frédéric Chibret, President of the Théa Group, said in a company news release.

Vevizye is designed to provide relief by reducing inflammation and improving ocular surface health. Its unique water-free EyeSol formulation is designed to enhance the drug’s stability and bioavailability, offering patients a more efficient treatment option.

The product was approved by the FDA in May 2023 as Vevye.

The efficacy of Vevizye has been demonstrated in two key clinical trials, ESSENCE-1 and ESSENCE-2. Both were randomized, multicenter, double-masked, vehicle-controlled studies that assessed the treatment’s impact on dry eye disease. The primary endpoint for both trials was the reduction in total corneal fluorescein staining (tCFS) scores at Day 29. Results showed a significant reduction in tCFS favoring Vevizye, with up to 71.6% of patients demonstrating a clinically meaningful improvement in corneal health within 4 weeks.

Secondary endpoints, including conjunctival staining and central corneal staining, also showed statistically significant improvements with Vevizye by Day 29. These benefits were sustained over the course of 56 weeks, demonstrating continued improvement in both the signs and symptoms of dry eye disease.