EGP-437 phase III study begins

Waltham, MA-EyeGate Pharma has enrolled the first patient in a milestone phase III pivotal study of its lead product EGP-437 (a late-stage asset with multiple indications for inflammatory ocular indications) for the treatment of anterior uveitis. The company, a private specialty pharmaceutical company developing therapeutics designed to address patient compliance and patient throughput, enrolled the patient at Tauber Eye Center in Kansas City, MO.

The randomized, double-masked, positive-controlled, non-inferiority study will enroll up to 200 patients at more than 20 U.S. sites to assess the effectiveness of EGP-437 in comparison with topically applied prednisolone acetate eye drops. EGP-437 will be administered using EyeGate’s non-invasive iontophoretic drug delivery technology (EyeGate II Drug Delivery System).

Study investigator Joseph Tauber, MD, said this approach seeks to address patient compliance by giving the doctor direct control of dosing.

“The phase II data suggest that EGP-437, when delivered using the EyeGate II Ocular Drug Delivery System, could lead to a more predictable clinical response and has the potential to improve the way anterior uveitis is treated,” he said.

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