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Novagali completes enrollment for phase 3 study of topical cyclosporine drug

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EVRY, France — Novagali Pharma SA has completed targeted patient enrollment for a multi-center phase 3 study of Nova22007, a topical formulation of cyclosporine A for the treatment of vernal keratoconjunctivitis, the company announced.

The study will be lead by David Ben-Ezra, MD, PhD, of Hadassah Hebrew University in Jerusalem. Dr. Ben-Ezra was the first surgeon to report on the efficacy of cyclosporine A for vernal keratoconjunctivitis, according to the press release.

The study follows Nova22007's receipt of orphan drug designation from the European Medicines Agency in March. Novagali hopes to complete the phase 3 study and apply for European marketing approval in mid 2007. It also plans to initiate phase 3 dry eye trials of Nova22007 in the United States and Europe, according to the release.