Company Plans to Initiate Randomized, Double-masked, Placebo-Controlled Study in First Half of 2017
WALTHAM, Mass., Dec. 05, 2016 — EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a specialty pharmaceutical company that focuses on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye, today announced promising data from the third stage of its Phase 1b/2a trial assessing lead product candidate, iontophoretic EGP-437, for the treatment of ocular inflammation and pain in post-surgical cataract patients.
Stage three of this multi-center, open-label clinical trial enrolled 30 subjects who have undergone cataract surgery with implantation of a posterior chamber intraocular lens (“IOL”). Patients were divided into three cohorts wherein they received iontophoretic doses of EGP-437 at either 4.5 mA-min or 14.0 mA-min, or a placebo at 14.0 mA-min. Subjects in the EGP-437 14.0 mA-min cohort were administered treatments on day 0 (pre-operative), day 1 and day 4. The other two cohorts were administered treatments on day 0 (post-operative), day 1 and day 4. The potential for an additional treatment on Day 7 at the physician’s discretion was allowed in all three cohorts.
A positive response, determined by a reduction in Anterior Chamber Cell (“ACC”) count, was observed in patients in both of the EGP-437 treatment arms. Those who were administered 4.5 mA-min dosing (3.0 mA for 1.5 minutes) realized the greatest benefit, with 30% and 80% of patients at day 14 and day 28 respectively, achieving complete reduction or an ACC count of zero. The placebo cohort required 80% of patients to be rescued prior to day 14 and only 10% had an ACC count of zero on day 28. Consistent with the first two stages of the trial, the procedure was very well tolerated in all subjects. Patients receiving EGP-437 at both dosing levels experienced reduced pain at all time points, with 70% of patients having a pain score of zero as early as day 1 versus the placebo cohort where only 10% achieved a pain score of zero 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 M.D., Chief Medical Officer of EyeGate. “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.”
“EyeGate is developing iontophoretic EGP-437 to potentially eliminate the need for daily corticosteroid eye drops currently used to manage post-surgery pain and inflammation, which could lead to improved outcomes for roughly 3 million patients who undergo cataract surgery in the U.S. each year. The results of this study demonstrate the promise of EGP-437, and we look forward to further demonstrating its ability to improve care for this significant patient population in the upcoming randomized controlled trial,” added Stephen From, Chief Executive Officer of EyeGate.
EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye. EGP-437, the Company’s first product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate® II Delivery System. In addition, EyeGate is developing, through its wholly-owned Jade subsidiary, products using cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form of the natural polymer hyaluronic acid (“HA”), which possesses unique physical and chemical properties such as viscoelasticity and water retention. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface make it well-suited for treating various ocular surface injuries. For more information, please visit www.EyeGatePharma.com.
Safe Harbor Statement
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate’s EGP-437 combination product, and the EyeGate Ocular Bandage Gel, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in EyeGate’s Annual Report on Form 10-K filed with the SEC on March 30, 2016, EyeGate’s Quarterly Report on Form 10-Q filed with the SEC on May 13, 2016, or described in EyeGate’s other public filings. EyeGate’s results may also be affected by factors of which EyeGate is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.