WALTHAM, MA / ACCESSWIRE / October 9, 2019 / EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) ('EyeGate' or 'the Company'), a clinical-stage company focused on developing products for treating disorders of the eye, announced today that it has completed randomization for its corneal wound repair pivotal study using the Ocular Bandage Gel ('OBG') eye drop.
The study enrolled a total of 250 patients requiring corneal wound repair following photorefractive keratectomy ('PRK') surgery. The enrollment process included a formal screening to determine suitability for the procedure, followed by surgery and subsequent randomization into either the OBG or standard-of-care group. Of the enrolled and screened patients, 234 qualified for surgery and randomization into the study.
'We are pleased with the efficiency of our team and sites for getting this study enrolled and keeping us on track for receiving topline data by year end 2019', said Stephen From, CEO of EyeGate. He continued, 'This pivotal study potentially puts us in a position to submit the de novo application for commercialization in the first half of 2020.'
EyeGate is a clinical-stage specialty pharmaceutical company focused on developing and commercializing products for treating diseases and disorders of the eye.
EyeGate's lead product, Ocular Bandage Gel ('OBG'), is based on a modified form of the natural polymer hyaluronic acid, which is a gel that possesses unique properties providing hydration and healing when applied to the ocular surface. EyeGate is in the clinic for two different patient populations: photorefractive keratectomy ('PRK') surgery to demonstrate corneal wound repair and punctate epitheliopathies ('PE'), which includes dry eye.
The objective of OBG is to re-epithelialize the cornea, reduce the risk of infection, improve symptoms, and improve ocular surface integrity. Often current treatments fall short as they are ineffective in protecting and enabling corneal re-epithelialization.
If EyeGate achieves successful completion of the PRK pivotal study and subsequent FDA approval, EyeGate believes OBG will be the only prescription hyaluronic acid eye drop in the U.S. and the only eye drop in the U.S. approved for the healing of corneal epithelial defects. Additionally, if the clinical trial for patients with PE is successful, EyeGate believes OBG will be the only eye drop in the U.S. approved for the treatment of PE.
EGP-437, EyeGate's other product, 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.
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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 OBG product, its EGP-437 Combination Product, 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 1, 2019 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.
Edison Advisors for EyeGate Pharmaceuticals
SOURCE: EyeGate Pharmaceuticals, Inc.
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