On track to report topline data in 2Q18 and file NDA within 2018
WALTHAM, Mass., Dec. 18, 2017 — EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage, specialty pharmaceutical company with two platform technologies for treating diseases and disorders of the eye, reported that the Phase 3 pivotal trial of EGP-437 for treatment of non-infectious anterior uveitis has reached 75% patient enrollment. Topline data is expected to be released in the second quarter of 2018.
“This is a critical step toward EyeGate’s goal of commercializing an alternative treatment option for anterior uveitis, a condition characterized by inflammation of the anterior chamber of the eye,” commented Barbara Wirostko, M.D., Chief Medical Officer of EyeGate. “We have made tremendous progress with this study and believe we remain on-track to report topline data from this trial in the second quarter of 2018, with an expected NDA filing for EGP-437 in anterior uveitis next year.”
The Phase 3 trial is a double-masked, randomized, positive-controlled trial enrolling 250 subjects in the U.S. It is designed to assess the safety and efficacy of iontophoretically-delivered EGP-437, a novel formulation of dexamethasone phosphate ophthalmic solution, through the company’s unique EyeGate® II Delivery System, in patients with non-infectious anterior segment uveitis. The value of the EyeGate® II Delivery System, is the ability to potentially eliminate the need for frequently administered topical steroids over multiple weeks. The primary efficacy endpoint is the proportion of subjects with an anterior chamber (AC) cell count of zero at day 14.
By achieving 75% enrollment in the study, EyeGate has earned a milestone payment under its licensing agreement with a subsidiary of Valeant Pharmaceuticals International (NYSE:VRX and TSX:VRX). In 2015, Eyegate and Valeant entered into an exclusive, worldwide licensing agreement, through which EyeGate granted Valeant exclusive, worldwide commercial and manufacturing rights to its EyeGate® II Delivery System and EGP-437 combination product in the field of uveitis, as well as a right of last negotiation to license such product for other indications. Valeant also has exclusive, worldwide rights to commercial and manufacture this combination product for the treatment of post-operative ocular inflammation and pain in ocular surgery patients, pursuant to a license agreement executed in February 2017.
EyeGate is a clinical-stage specialty pharmaceutical company focused on developing and commercializing products using its two proprietary platform technologies for treating diseases and disorders of the eye.
EyeGate’s CMHA-S platform is based on cross-linking thiolated carboxymethyl hyaluronic acid, a modified form of the natural polymer hyaluronic acid (“HA”). This is a gel that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries.
EGP-437, EyeGate’s other 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. www.EyeGatePharma.com.
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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 those of Jade Therapeutics, Inc., a wholly owned subsidiary of EyeGate, 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 February 23, 2017 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.