EyeGate Pharmaceuticals today acknowledged that its combination treatment EGP-437 (Delivered by Iontophoresis System), envisioned as an alternative to eye drops and injections, has failed a Phase IIb trial in patients with pain and inflammation after undergoing cataract surgery.
EGP-437 missed its co-primary 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.
While the combination treatment showed a higher rate of success compared with vehicle at all timepoints of the study, that difference was not statistically significant, EyeGate said.
According to the company, 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.
“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, M.D., strategic advisor to EyeGate, said in a statement.
Dr. Olson added: “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.”
Stock Falls 39%
Investors apparently disagreed, as news of the failure touched off a stock selloff that sent EyeGate shares falling 39% in early trading, from Friday’s closing price of $1.03 per share down to 63 cents per share as of 10:10 a.m.
EGP-437 incorporates a reformulated topically active corticosteroid, dexamethasone phosphate, that is delivered into the ocular tissues through EyeGate’s proprietary drug delivery system, the EyeGate® II Delivery System.
Based on technology originating at the Bascom Palmer Eye Institute at the University of Miami, EyeGate II uses transscleral iontophoresis to deliver optimal therapeutic levels of drug directly into the targeted ocular tissue. EyeGate says EGP-437 offers an alternative to eye drops and ocular injections—and has been used in over 2000 clinical treatments to-date, including more than 1300 treatments delivering EGP-437.
The Phase IIb trial was designed to assess the safety and efficacy of transscleral iontophoretically delivered EGP-437, dexamethasone, via the company’s EyeGate II Delivery System in patients that have previously undergone cataract surgery with implantation of a monofocal posterior chamber intraocular lens (IOL), starting immediately after surgery.
The double-masked, randomized, vehicle-controlled study enrolled 106 subjects at seven U.S. clinical sites.
For the secondary endpoints, EyeGate added, EGP-437 showed statistically significant improvements in both ACC count and pain score on day 7 and day 1, respectively, based on change in mean cell count and change in mean pain score. The EGP-437 arm also demonstrated a favorable safety profile with no serious adverse events reported, the company 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,” EyeGate CMO Barbara Wirostko, M.D., added.