EyeGate Files FDA Submission to Initiate PE Pilot Study

WALTHAM, MA / ACCESSWIRE / July 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 it has filed a protocol with the FDA for a follow-on pilot study using the Ocular Bandage Gel (“OBG”) eye drop to treat punctate epitheliopathies (“PE”) which can be associated with dry eye. The FDA review process takes 30 days, at which point the FDA will allow the Company to initiate enrollment or will provide comments to be addressed.

The objective of this study is to evaluate several different exploratory performance endpoints in PE patients. Following data from this study, which is expected by year end 2019, EyeGate plans to meet with the FDA to discuss the results and confirm the most ideal endpoint to use in the pivotal study.

OBG is based on a modified form of the natural polymer hyaluronic acid (“HA”), which is an eye drop that possesses unique properties providing hydration and healing when applied to the ocular surface. As recently announced, EyeGate has enrolled the first patient for the corneal wound repair pivotal study. The Company plans to have two clinical studies open and enrolling, expanding the uses for OBG, with both studies anticipated to have data by year end 2019.

Stephen From, CEO of EyeGate, said “This is potentially a large opportunity, as OBG would be the only eye drop treatment available for the millions of patients in the U.S. with PE and tear film instability. We continue to explore new uses for our HA polymer and believe that its unique crosslinked capabilities will better serve patients who suffer from ocular surface pathologies and corneal injuries.“

About EyeGate

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.

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 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.

CONTACT:

Joseph Green / Laine Yonker
Edison Advisors for EyeGate Pharmaceuticals
646-653-7030 / 7035
jgreen@edisongroup.com / lyonker@edisongroup.com

SOURCE: EyeGate Pharmaceuticals

View source version on accesswire.com:
https://www.accesswire.com/551138/EyeGate-Files-FDA-Submission-to-Initiate-PE-Pilot-Study