Phase III study to investigate dry eye therapy

Waltham, MA-EyeGate Pharma has begun enrolling patients in the ALLUVION (EvALuation of Dexamethasone Phosphate DeLivered by OcUlar Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse EnVIrONment [CAE] Model) pivotal phase III study of EGP-437 for the treatment of dry eye syndrome.

EGP-437 is a dexamethasone-derived corticosteroid custom formulated for delivery using a proprietary system (EyeGate II).

As announced in June 2009, an exploratory phase II study demonstrated significant improvements in the signs and symptoms of dry eye during and after CAE exposure. The CAE exacerbates the signs and symptoms of dry eye in a controlled setting.

The company submitted to the FDA information from the completed phase II study of patients with dry eye as part of an end-of-phase II meeting. Under an investigational new drug application, EyeGate is the first company to complete phase II studies using iontophoresis technology to deliver an active compound into the eye, according to the company.

“Based on clinical data, we recognize the potential value that EGP-437 may offer patients. Thus, we are excited to initiate this important pivotal study, which moves the company one step closer to submitting a new drug application,” said Stephen From, president and chief executive officer of EyeGate Pharma. “Demonstrating that iontophoretically delivered drugs offer ophthalmologists new treatment options for patients is an important milestone for the company.”