EyeGate Pharmaceuticals announced completion of patient enrollment for the pivotal phase 3 clinical study of its EGP-437 combination product for the treatment of noninfectious anterior uveitis.
The double-masked, randomized, positive-controlled trial enrolled 250 patients in the United States. The trial was designed to assess the safety and efficacy of iontophoretically-delivered EGP-437 in patients with unilateral or bilateral noninfectious anterior segment uveitis.
The primary efficacy endpoint of the trial was the proportion of subjects with an anterior chamber (AC) cell count of zero at day 14. Subjects were provided three treatments of either EGP-437 iontophoresis treatment or a placebo iontophoresis treatment. Patients enrolled in the EGP-437 arm were provided placebo eye drops, while patients receiving placebo iontophoresis treatment are given prednisolone acetate (1%) drops. Eye drops for both arms were administered for a period of up to 28 days and for up to 8 drops per day.
“Completion of patient enrollment in this confirmatory phase 3 clinical trial evaluating our unique EGP-437 combination product represents a major milestone for the company,” Stephen From, President and Chief Executive Officer of EyeGate, said in a company news release. “Congratulations to our committed team of trial investigators and coordinators on this critical milestone. We expect top line data in the third quarter and, assuming positive data from this trial, we plan to submit a new drug application to the FDA in the first half of 2019."
In 2015, EyeGate and a subsidiary of Valeant Pharmaceuticals International entered into an exclusive, worldwide licensing agreement, through which EyeGate granted Valeant worldwide commercial and manufacturing rights, as part of its Bausch + Lomb business, to its EyeGate II Delivery System and EGP-437 combination product in the field of uveitis. Completion of patient enrollment has triggered a milestone payment from Valeant under this licensing agreement.