Responses to the last of four outstanding action items submitted; Potential to start clinical study in the Third Quarter of 2018
WALTHAM, Mass., June 22, 2018 (GLOBE NEWSWIRE) -- 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 the final action item in the U.S. Food and Drug Administration’s (FDA) review of its Investigational Device Exemption (IDE) for a second pilot study of the Company’s Ocular Bandage Gel (OBG). EyeGate’s product is 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 original 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. This amendment addresses the final FDA concern regarding the validation of a filter used in the sterilization process. The previous FDA action items were addressed in an amendment, filed on May 22, 2018, and were cleared by the FDA on June 18, 2018.
Stephen From, President and Chief Executive Officer of EyeGate, said, “We are pleased to have completed our response to the FDA’s final comment.” Mr. From continued, “With this final comment addressed, and the previous action items cleared, we believe we have a pathway to approval to initiate of the next stage of clinical studies. We anticipate entering the clinic in the third quarter of 2018.”
The 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 has 30 days to review the amendment and either request additional data or approve the responses.
About EyeGate
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.
EyeGate Social Media
EyeGate uses its website (www.EyeGatePharma.com), Facebook page (https://www.facebook.com/ EyeGatePharma/), corporate Twitter account (https://twitter.com/EyeGatePharma), and LinkedIn page (https://www.linkedin.com/company/135892/) as channels of distribution of information about EyeGate and its product candidates. Such information may be deemed material information, and EyeGate may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor EyeGate’s website and its social media accounts in addition to following its press releases, SEC filings, public conference calls, and webcasts. The social media channels that EyeGate intends to use as a means of disclosing the information described above may be updated from time to time as listed on EyeGate’s investor relations website.
Forward-looking Statements
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.
Contact
Joseph Green / Andrew Gibson
Edison Advisors for EyeGate Pharmaceuticals
646-653-7030 / 7019
jgreen@edisongroup.com / agibson@edisongroup.com