Novaliq has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CyclASol, which it describes as a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED).
CyclASol (cyclosporine ophthalmic solution) uses the company’s EyeSol water-free technology. Results from a 12-month study confirmed a rapid onset therapeutic effect in DED patients, with clinically meaningful improvement of ocular surface damage and excellent tolerability, said Novaliq in a statement, adding those effects were maintained and even improved for most sign and symptom endpoints.
“This is the second NDA acceptance of water-free dry eye therapies in less than three months. The two distinct modalities of action of the EyeSol-based dry eye therapies open new and complementary clinical prospects on how to treat DED in the future,” said Dr Sonja Krösser, Novaliq’s vice president of preclinical and clinical development.
The company plans to submit a marketing authorisation application to the European Medicines Agency and other authorities in 2023.
