Novagali Pharma Announces Positive Data on Topical Cyclosporine

Novagali Pharma has announced positive results from the Phase III clinical study of Vekacia in children suffering from vernal keratoconjunctivitis (VKC). The study showed that that both the symptoms and signs of disease improved in patients receiving Vekacia. Furthermore, the tolerability to Vekacia was excellent, the company said.

VKC is a severe form of chronic allergic conjunctivitis characterized by ocular discomfort, pain, itching and intense photophobia, which severely debilitates the patients.

Vekacia is a topical cyclosporine A cationic emulsion enabling an efficient and unmatched level of drug absorption in tissues of the eye leading to optimal therapeutic efficacy. In March 2006, Novagali received European Medicines Agency (EMEA) orphan drug designation for Vekacia in the treatment of VKC.

"We achieved a major corporate milestone completing our first Phase III clinical trial" Jerome Martinez, president and CEO of Novagali, said. "I am very enthusiastic about the confirmation of the high potential of Novasorb cationic emulsion technology through the development of Vekacia and its successful use in VKC."

Based on the results of the study, the company said it plans to file for European marketing authorization by mid-2007.