FDA grants IND for dry eye product

Novagali Pharma's Investigational New Drug Application (IND) to conduct a pivotal Phase III clinical trial of its dry eye candidate, Nova22007, has been granted by the FDA.

Nova22007 is a cyclosporine A ophthalmic product developed for the treatment of patients with moderate to severe dry eye syndrome. The proprietary cationic emulsion enables penetration of the drug into tissues of the ocular surface.

The planned double-masked, randomized, vehicle-controlled study will evaluate the efficacy of Nova22007 in relieving objective and subjective dry eye symptoms.