Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye Disease

Novaliq announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization in the European Union for dry eye drug Vevizye.

Vevizye is intended for the treatment of moderate to severe dry eye disease in adult patients, which has not improved despite treatment with tear substitutes.

Vevizye, development name CyclASol, is a clear ciclosporin 0.1% solution, free of oils, surfactants, and preservatives, offering superior spreading properties and increased residual time on the ocular surface, according to Novaliq.

Novaliq submitted a Marketing Authorization Application (MAA) for Vevizye in July 2023 under the centralised procedure. The positive opinion is based on the CHMP review of the comprehensive data package from more than 1.500 patients with moderate to severe DED.

“Clinical data for Vevizye showed clinically meaningful improvements of the ocular surface as early as 2 weeks, combined with an excellent tolerability profile and high treatment satisfaction,” Professor José M. Benítez del Castillo, Chair of the Department of Ophthalmology at University Complutense Madrid (Spain), said in a company news release. “I am enthusiastic that there will be a new treatment option addressing these important aspects of a dry eye therapy in Europe.”

Vevizye demonstrated clinically meaningful and statistically significant improvements in moderate and severe DED patients in two independent adequate and well-controlled, multicenter studies (ESSENCE-1 and ESSENCE-2) across various endpoints. These included effects on the ocular surface with a statistically significant reduction in total corneal fluorescein staining score favoring Vevizye as early as on Day 15. Up to 71.6% of patients responded within 4 weeks with a clinically meaningful improvement in total corneal fluorescein staining. Responders showed statistically significant improvements in a variety of symptoms compared to non-responding patients within 4 weeks. Continued and relevant improvement under therapy in both signs and symptoms of DED were demonstrated over a period of up to 56 weeks, confirming Vevizye’s favorable tolerability and efficacy profile.

In May 2023, the FDA approved CyclASol under the brand name Vevye. The product was launched in the United States in January 2024 by Harrow.