Despite demonstrating a higher rate of success compared with vehicle at all time points, EGP-437 for pain and inflammation in cataract surgery patients did not meet its co-primary endpoints in a phase 2b study.
Neither the proportion of patients with an anterior chamber cell count of zero at day 7 or the proportion of patients with a pain score of zero at day 1 showed statistical significance in the double-masked, randomized, vehicle-controlled trial of EGP-437 (iontophoretically delivered dexamethasone), according to a press release from EyeGate Pharmaceuticals.
“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,” Randall Olson, MD, EyeGate’s strategic advisor, said in the release.
The product candidate showed numerically better clinical efficacy throughout the study, especially at and beyond day 14, and a greater number of subjects who were administered EGP-427 achieved a pain score of zero, the release said.
“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,” Barbara Wirostko, MD, EyeGate’s chief medical officer, said in the release.