EyeGate Pharmaceuticals announced topline results from a phase 2b study of EGP-437 combination product for pain and inflammation in patients having undergone cataract surgery. Although, EGP-437 demonstrated a higher rate of success compared to vehicle at all time points, the coprimary endpoints of proportion of subjects with an anterior chamber cell (ACC) count of zero at day 7 and the proportion of subjects with a pain score of zero at day 1 did not show statistical significance.
“The efficacy results for the absence of inflammatory cells in the EGP-437 treatment group met our expectations, but the vehicle group response was better than anticipated. The magnitude of reduction for EGP-437 compares favorably with the historical data from studies of other anti-inflammatory products, which we believe is an encouraging sign,” Randall Olson MD, strategic advisor to EyeGate, said in a company news release.
The double-masked, randomized, vehicle-controlled phase 2b study enrolled 106 subjects at seven U.S. clinical sites. The trial evaluated the safety and efficacy of trans-scleral iontophoretically-delivered EGP-437, dexamethasone, through the company’s EyeGate II Delivery System in patients that have previously undergone cataract surgery with implantation of a monofocal posterior chamber IOL, starting immediately after surgery.
EGP-437 showed numerically better clinical efficacy, defined as an ACC count of zero, throughout the study, especially at day 14 and beyond. At a majority of timepoints, a greater number of subjects in the EGP-437 arm achieved a pain score of zero compared to control. For the secondary endpoints, based on change in mean cell count and change in mean pain score, EGP-437 showed statistically significant improvements in both ACC count and pain score, on day 7 and day 1 respectively. In addition, the EGP-437 arm demonstrated a favorable safety profile with no serious adverse events reported.
“We will continue to review the data to determine next steps and to continue evaluating EGP-437 for the reduction of pain and inflammation following ocular surgery,” said Barbara Wirostko MD, Chief Medical Officer of EyeGate.