EyeGate Pharma to Proceed with PE Pivotal Study
WALTHAM, MA / ACCESSWIRE / July 14, 2020 / 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 based on feedback from a meeting with the U.S. Food and Drug Administration ("FDA"), EyeGate can move forward with the filing of an IDE for a punctate epitheliopathies ("PE") pivotal study.
This pivotal study follows the successful completion of EyeGate's pilot study in early 2020. The pivotal study will evaluate the effectiveness and safety of EyeGate's Ocular Bandage Gel eye drop in reducing PEs in a dry eye patient population to be further defined in the IDE. Prior to filing the IDE application for the pivotal study, the Company must perform additional testing for the new packaging, a multi-dose preservative-free bottle, as previously discussed with the FDA. The Company anticipates completing this testing by the end 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. The objective of OBG is to protect the ocular surface in order for the body to re-epithelialize the cornea and improve ocular surface integrity. The product is applied as a clear topical gel, to the damaged ocular surface and possesses unique properties that help hydrate and protect the ocular surface to allow for wound healing. EyeGate is in clinical evaluation for two different patient populations: (1) patients undergoing photorefractive keratectomy ("PRK") surgery to demonstrate corneal wound repair after refractive surgery; and (2) patients with punctate epitheliopathies ("PE") as a result of dry eye to promote reduction of PEs.
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 clearance/approval efforts pertaining to EyeGate's products, including EyeGate's OBG product, as well as the success thereof, with such clearances/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 4, 2020 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/Laine Yonker
Edison Group for EyeGate Pharmaceuticals
email@example.com / firstname.lastname@example.org
SOURCE: EyeGate Pharmaceuticals, Inc.
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Released July 14, 2020