EyeGate’s EGP-437 for Post-Cataract Pain, Inflammation Produces Mixed Results in Phase IIb Trial

February 9, 2018: By Jon Swedien

EyeGate Pharmaceuticals’ EGP-437 outperformed the vehicle in its Phase IIb study, but the product candidate for post-cataract pain and inflammation failed to meet the study’s co-primary endpoints.

The vehicle group’s response was better than anticipated, EyeGate said.

The double-masked, randomized, vehicle-controlled Phase IIb study enrolled 106 subjects at seven US clinical sites and evaluated the safety and efficacy of transscleral iontophoretically delivered EGP-437, dexamethasone, through the company’s EyeGate II Delivery System.

Patients in the study had undergone cataract surgery and been implanted with a monofocal posterior chamber IOL. They received treatment beginning immediately after surgery.

The study’s primary endpoints were:

–Proportion of subjects with an anterior chamber cell count of zero at day seven;

–Proportion of subjects with a pain score of zero at day one.

EGP-437 demonstrated a higher rate of success compared with vehicle at all time points, but the difference between its scores and the placebo’s scores did not demonstrate statistical significance, EyeGate said.

EyeGate will continue evaluating EGP-437 for post-ocular surgery pain and inflammation, said Barbara Wirostko, MD, the company’s chief medical officer.

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