Shares of Eyegate Pharmaceuticals Inc (NASDAQ:EYEG) dropped by as much as 47% in early trading Monday. The reason? The stock’s double-digit nosedive was sparked by disappointing top-line results from a phase 2b trial of the company’s EGP-437 combination product for pain and inflammation in patients having undergone cataract surgery.
Eyegate reported that the 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 did not show statistical significance. However, the trial did demonstrate a higher rate of success compared to vehicle at all time points.
“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,” said Randall Olson MD, strategic advisor to EyeGate.
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.
On the ratings front, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on EYEG, with a price target of $5.00, in a report issued on December 19. The current price target implies an upside of 747% from current levels. According to TipRanks.com, Selvaraju has a yearly average loss of 11.1%, a 32% success rate, and is ranked #4702 out of 4745 analysts.
EyeGate Pharma is a clinical stage specialty pharmaceutical company, which engages in the development and commercialization of products for treating diseases and disorders of the eye. Its products include EGP-437 and EyeGate II Delivery System. EGP-437 treat non-infectious anterior uveitis, a debilitating form of intraocular inflammation of the anterior portion of the uvea, such as the iris or ciliary body. The EyeGate II Delivery System delivers drugs non-invasively and quickly into the ocular tissues through the use of iontophoresis, which can accelerate the onset of action, dramatically reduce treatment frequency versus eye drops and sustain therapeutic effect.