WALTHAM, Mass., November 5, 2015 — 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 interim data on the effects of iontophoretic delivery of their EGP-437 ophthalmic solution on Macular Edema patients.
“Overall, the interim data from this pilot trial suggests that iontophoresis can non-invasively deliver EGP-437 to the back of the eye. The non-invasive delivery of EGP-437 has demonstrated a positive response in some patients with macular edema. We believe that this data is encouraging, and warrants an extension to the trial to continue to work on the ideal dose and dosing regimen for the iontophoretic delivery of EGP-437,” said Dr. Jeffrey Heier, M.D., Director of Vitreoretinal Service and Retina Research at Ophthalmic Consultants of Boston and the principal investigator of the trial.
The ongoing Phase 1b / 2a clinical trial is a multi-center, open-label trial. To date, the trial has enrolled 19 patients with macular edema associated with Retinal Vein Occlusion, Diabetic Retinopathy or Post-Surgical (cystoid) Macular Edema. The primary objective of this trial was to evaluate the safety and efficacy of iontophoretic EGP-437 in patients suffering from Macular Edema. Three treatments at 14.0 mA-min (3.5mA) were administered on day 0, day 4 and day 9. Primary outcome of the trial measured reduction in mean central subfield thickness on day 4, day, 9 and day 14. Ozurdex® was administered as control to patients that did not respond to the investigational therapy at day 14 and were re-evaluated at day 28.
A positive response was observed in some of the patients, with pseudophakic eyes (an eye implanted with an intraocular lens) responding better than phakic eyes (an eye with a natural lens). Additionally, the investigational therapy showed no serious treatment emergent adverse effects including no increase in ocular pressure even at three times the iontophoretic dose that was used for the Company’s Phase 3 non-infectious anterior uveitis trial.
“The interim results of the trial are highly promising and suggest the ability of the EyeGate® II Delivery System to deliver drug to the posterior segment of the eye, which could present important new opportunities for our iontophoretic technology and drug formulations in additional disease indications. We look forward to additional data from the extension of this trial, which we expect in mid-2016,” said Stephen From, President and Chief Executive Officer of EyeGate.
The extension stage of the trial will recruit an additional 15 patients with a modified dosing regimen, 3 consecutive days at the same iontophoretic dosage. It was observed that the edema returns when drug has cleared from the tissues. Thus the new dosing regimen may help to overcome this issue by providing a cumulative effect. The extension of the trial will also evaluate the efficacy of iontophoretic EGP-437 in phakic versus pseudophakic eyes to collect additional data on the differences in the responses of both types of eyes. This data may be interesting from a physiological standpoint and will be helpful in designing further clinical trials. The extension of the trial is expected to begin by the end of 2015.
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 and only 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. 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 EGP-437, 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 our Annual Report on Form 10-K filed with the SEC on March 31, 2015, or described in our other public filings. Our results may also be affected by factors of which we are 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.
Lee Roth / Joseph Green
The Ruth Group for Eyegate Pharmaceuticals
646-536-7012 / 7013
firstname.lastname@example.org / email@example.com