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news.French biopharm company Novagali Pharma has successfully completed a phase II clinical study of its formulation of cyclosporine A, a treatment indicated for dry eye syndrome, demonstrating the product's safety.
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The results of the investigation demonstrate the safety and potential efficacy of Novagali’s treatment, called Nova22007, in patients suffering from Sjogren syndrome. This syndrome is a type of auto-immune disorder associated with keratoconjunctivitis sicca, an alteration in the eye surface brought about by dry eye syndrome.
“These results confirm the safety of our formulation in patients suffering from moderate-to-severe keratitis,” Dr Florence Binlich, Novagali’s medical director. “Confirmation of the efficacy trends during future phase III trials would establish Nova22007 as a truly significant therapeutic advance for dry eye patients”.
Novagali plans to start phase III studies in 2006.
Nova22007 is a proprietary cationic emulsion enabling an optimal penetration of cyclosporine A in tissues of the eye surface. Cyclosporine was originally sold by Novartis under the brand name Sandimmune. Generic versions have also been produced by companies such as Sangstat, Abbott Laboratories and Gengraf.
Cyclosporine A is the reference molecule for treatment of keratoconjunctivitis sicca with immune and inflammatory etiologies. According to Novagali, its sales are predicted to reach $300 million in 2008 in the US alone.