EyeGate Pharmaceuticals announced positive results for their phase 1b/2a trial assessing EGP-437, a dexamethasone phosphate formulation administered through transscleral iontophoresis, which the company expects to offer as an alternative to eye drops for pain and inflammation after cataract surgery.
EGP-437 is administered with the EyeGate II Delivery System, which uses a gentle applied electrical field to drive the ionized glucocorticosteroid through the sclera in substantially higher ocular drug concentrations than traditional topical applications, and without the inherent patient compliance issues with eye drops.
This study arm enrolled 30 patients who had undergone cataract surgery with implantation of a posterior chamber IOL. Patients were randomized to receive EGP-437 at either 4.5 mA-min or 14.0 mA-min, or a placebo at 14.0 mA-min. The 14.0 mA-min cohort received treatments on day 0 (pre-operative), and days 1 and 4. The other two cohorts received treatments on day 0 (post-operative), and days 1 and 4. Additional treatment on Day 7 at the physician’s discretion was allowed in all three cohorts.
A positive response, measured by reduction in anterior chamber cell (ACC) counts, was seen in both EGP-437 groups. According to EyeGate, patients in the 4.5 mA-min dosing (3.0 mA for 1.5 minutes) group showed the greatest benefit, with 30% achieving a 0 ACC count by day 14, and 80% by day 28. In comparison, only 10% of placebo patients achieved a 0 ACC count by day 28, and 80% required rescue therapy prior to day 14. The treatment also displayed a significant pain-reduction effect, as patients receiving either EGP-437 dosing experienced reduced pain at all time points compared to placebo, and 70% had a pain score of by day 1. In the placebo cohort, only 10% reported to be pain free at day 1.
“We are highly encouraged by the results of this third stage of the Phase 1b/2a study of iontophoretic EGP-437, which reinforce our belief that this product merits further evaluation as a potential treatment for pain and inflammation following cataract surgery,” said Barbara Wirostko MD, EyeGate’s chief medical officer. “We are particularly excited by the outcomes in the 4.5 mA-min treatment arm, which compare favorably to both the placebo arm of this trial and historical data for the current standard of care on reduction in ACC count and improvement in pain score. The data from all stages of this study will form the basis for a randomized, double-masked, placebo controlled trial of iontophoretic EGP-437 in cataract surgery patients, which we expect to initiate in the first half of 2017.”
In line with a previous stage of the trial, the treatment was very well tolerated and no steroid-related increase in IOP was found.