Novagali Pharma Announces FDA Clearance Of IND For US Pivotal Phase III Trial Of Nova22007 For Treatment Of Dry Eye Syndrome

Nova22007 be a Cyclosporine A ophthalmic service considered to be once owned to too much of a honest thing patients sadness from moderate-to-severe Dry Eye Syndrome. Nova22007 is a proprietary cationic emulsion enable an optimal permeation of Cyclosporine A contained via tissues of the eye airliner that godsend from Novasorb® cationic emulsion technology features.

"While ICD recalls affect a notable figure of patients, their overall impact on patient survival be not meaningfully at likelihood," said Arthur C. Kendig, M.D., Cleveland Clinic Foundation and a co-author of the study.

This IND hound a pre-IND/end of Phase II round-table held with the FDA in July 2006. The FDA has revision the trait, refuge and efficacy numbers generate by Novagali in European Phase II clinical assessment poll of Nova22007 in patients suffering from Sjögren syndrome associated with keratoconjunctivitis sicca (dry keratitis). In codicil, the FDA has partake documentary guidance by the tenderloin of the U.S. Phase III trial protocol. The intentional, double-masked randomized vehicle-controlled study will weigh against the efficacy of Nova22007 in confess thirsty eye demonstration and sketchy symptom.

"FDA clearance of Nova22007 IND in support of a pivotal Phase III study represent an major milestone for Novagali, authenticate our optical technology stage Novasorb®" said Jerome Martinez, president and CEO of Novagali Pharma. "With our upcoming leg III trial in the EU, the two pivotal study would enable to maintain a record of the Product in both US and EU, and provide patients with a ultramodern and uniquely-improved dry eye prescription product".

This good product is distinct to Cationorm®, a cationic emulsion dyed-in-the-wool to dry eye relief benefit from Novasorb® features. Cationorm® received CE chisel in Europe and comply with US ocular OTC monograph in place of an eye lubricant product.

About Novagali Pharma Novagali Pharma SA is an emerging ophthalmic pharmaceutical tenacious scum in the Genopole biocluster in Evry, France, that grow innovative products for all segment of the eye. Thanks to its proprietary technology platform Novasorb® and Eyeject®, the company has manufacturing a extensive pipeline of innovative products address prevalent ocular jargon also as waif illness. Most advanced products contain Vekacia®, an orphan product for attention of vernal keratoconjunctivitis; Cationorm®, a CE mark product for dry eye relief; and Nova22007, a product for the treatment of moderate-to-severe dry eye syndrome. Founded in 2000, the firm has raise a unreserved amount of Euro 44 million in 3 array of finance.

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