FDA OKs Novaliq Dry Eye Drug

FDA has approved a Novaliq NDA for Vevye (cyclosporine ophthalmic solution) 0.1% for treating the signs and symptoms of dry eye disease. Approval was based on data from 1,369 patients with dry eye disease, which demonstrated that the product was safe, well tolerated, and has a consistent, and durable therapeutic effect., according to the company. “The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis,” it says. On the safety side, the most common adverse reactions were instillation site reactions (8%) and temporary decreases in visual acuity (3%).

Dry eye disease affects millions of Americans and is a common ocular surface disorder, according to the company. “The chronic inflammatory nature causes progressive corneal surface damage that can lead to direct or indirect visual impairment,” it says.