Novagali Pharma announces FDA clearance of trial for treatment of dry eye syndrome

Novagali Pharma has announced that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase III clinical trial of its Cyclosporine A ocular product, Nova22007, has been granted by the U.S. Food and Drug Administration (FDA).

Nova22007 is a Cyclosporine A ophthalmic product intended to be used to treat patients suffering from moderate-to-severe Dry Eye Syndrome. Nova22007 is a proprietary cationic emulsion enabling an optimal penetration of Cyclosporine A in tissues of the eye surface that benefit from Novasorb(R) cationic emulsion technology features.

As part of this IND, the FDA has agreed that Novagali may proceed directly into pivotal Phase III clinical trials in the United States in patients with moderate-to-severe Dry Eye Syndrome. This IND follows a pre-IND/end of Phase II meeting held with the FDA in July 2006. The FDA has reviewed the quality, safety and efficacy data generated by Novagali in European Phase II clinical study of Nova22007 in patients suffering from Sjogren syndrome associated with keratoconjunctivitis sicca (dry keratitis). In addition, the FDA has provided written guidance on the U.S. Phase III trial protocol. The planned, double-masked randomized vehicle-controlled study will evaluate the efficacy of Nova22007 in relieving dry eye objective and subjective symptoms.

"FDA clearance of Nova22007 IND for a pivotal Phase III study represents an important milestone for Novagali, validating our ocular technology platform Novasorb(R)" said Jerome Martinez, president and CEO of Novagali Pharma. "With our upcoming phase III trial in the EU, the two pivotal studies would enable to register the Product in both US and EU, and provide patients with a novel and uniquely-improved dry eye prescription product".

This ethical product is complementary to Cationorm(R), a cationic emulsion dedicated to dry eye relief benefiting from Novasorb(R) features. Cationorm(R) received CE mark in Europe and complies with US ocular OTC monograph as an eye lubricant product.