Fovea reports positive results from allergic conjunctivitis trial

Fovea Pharmaceuticals, a French biopharmaceutical company, has reported positive results from its clinical proof-of-concept trial to assess the therapeutic effect of Prednisporin in patients with persistent allergic conjunctivitis.

According to Fovea, Prednisporin had the same efficacy and a better safety profile than PredForte, a prescription drug with a 10 fold higher dose of prednisolone acetate, in patients treated for the signs and symptoms of persistent ocular allergic inflammation. A one-week pre-treatment with Pataday had negligible effect on these parameters in this patient population.

The prospective, multicenter, randomized, double masked, bilateral comparison study with 150 patients was conducted by Ora in the US utilizing Ora’s Enviro-CAC clinical technology. The combination therapy of low doses cyclosporine A and prednisolone acetate was compared to PredForte alone or vehicle alone during a two-week dosing period.

Fovea is now preparing pivotal trials for Prednisporin both in the US and in Europe with the goal of filing new drug applications late 2010.

Bernard Gilly, chairman and CEO of Fovea, said: We are extremely pleased with these results, and they are totally in line with our expectations. We believe that Prednisporin has the potential to provide safe and effective therapy to millions of patients suffering from chronic inflammatory conjunctivitis, a complex indication, that is not addressed by existing treatments.