WALTHAM, Mass., May 30, 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 the filing of an Investigational Device Exemption (IDE) supplement for Punctate Epitheliopathy (PE), using the Company’s Ocular Bandage Gel (OBG) product. EyeGate OBG 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) and punctate epitheliopathies.
PE represents an unmet medical need and is an opportunity for EyeGate’s OBG platform to expand to additional indications. There are over 76 million patients with corneal epitheliopathies in the United States. Current treatment approaches are limited, and may include artificial tears, increasing humidity, usage of lubricants/ointments and, in severe cases, the utilization of bandage contact lenses, antibiotics and/or anti-inflammatory/immunomodulatory agents. EyeGate believes there is a sentiment among physicians and optometrists supporting the need for additional or more effective treatments to be in place for PE, as well as other conditions such as dry eye and wound management.
Stephen From, President and Chief Executive Officer of EyeGate, said, “The filing of this IDE supplement represents the next step for our OBG platform, and shows EyeGate’s continued progress.” Mr. From continued, “We are hopeful that we will receive a positive response to this IDE supplement, and will be able to move into the clinic in the second half of 2018.”
Clinical trials for PE are subject to an approval of both this IDE and to a positive resolution of the four outstanding items cited by the FDA in EyeGate’s IDE for PRK. Currently, three of the four items in the IDE for PRK have been addressed while the fourth is expected to be addressed by the end of the Second Quarter of 2018.
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.
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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