Nova22007 is a cyclosporine A ophthalmic product intended to be used to treat patients suffering from moderate-to-severe dry eye syndrome.
As part of the trial approval, the FDA has reviewed the quality, safety and efficacy data generated by a 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 phase III trial protocol. The 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,” 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.”