Responses to three of the four outstanding action items submitted; Response to Fourth action item Expected in the Second Quarter of 2018 with Potential to start clinical study in the Third Quarter of 2018
WALTHAM, Mass., May 22, 2018 — EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) (“EyeGate” or the “Company”), a clinical-stage, specialty pharmaceutical company with two proprietary platform technologies for treating diseases and disorders of the eye, today announced that it has addressed three of the four outstanding items in a Second Amendment in response to the U.S. Food and Drug Administration’s (FDA) review of its first amendment. EyeGate has demonstrated continued progress towards achieving the Investigational Device Exemption (IDE) for a second pilot study of the Company’s Ocular Bandage Gel (OBG) product, a cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform being developed for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK).
In the IDE amendment response letter, the FDA identified four insufficiencies in the Company’s submission and requested additional information on the manufacturing processes associated with the EyeGate OBG product. These comments related to a request for clarification to the previously submitted data, modifications to the manufacturing process documents and validation of a filter used in the sterilization process. The clarification of questions on the data and documentation changes have been addressed in this most recent submission, while work continues on the filter validation requirement.
Stephen From, President and Chief Executive Officer of EyeGate, said, “We are pleased to have completed and submitted responses to three of the four outstanding parts of the first IDE amendment, which had previously addressed the majority of the thirteen issues raised in the FDA’s initial response. The feedback originally provided by the FDA gave EyeGate clarity on the direction and path to approvability of the application.” Mr. From continued, “With this next step forward, we are now even closer to the initiation of the next stage of clinical studies. We anticipate addressing the fourth and final concern by the end of the second quarter of 2018 which would allow us to enter the clinic in the third quarter of 2018.”
The second amendment to the IDE submission is subject to review by the Center for Devices and Radiological Health (CDRH) of the FDA. Once submitted, the FDA will have 30 days to review the second amendment and either request additional data or approve the responses.
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 a cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S), a modified form of the natural polymer hyaluronic acid (HA), which 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. 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 EGP-437 combination product and the EyeGate OBG 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 2, 2018 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.
Joseph Green / Andrew Gibson
Edison Advisors for EyeGate Pharmaceuticals
646-653-7030 / 7019
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