WALTHAM, MA / ACCESSWIRE / November 22, 2019 / EyeGate Pharmaceuticals, Inc. (EYEG) (“EyeGate” or “the Company”), a clinical-stage company focused on developing products for treating disorders of the eye, announced today that it has received select topline data, specifically the primary endpoint, demonstrating superiority over standard-of-care in its corneal wound repair pivotal study using the Ocular Bandage Gel (“OBG”) eye drop.
The results of this critical study demonstrated that EyeGate’s OBG eye drop provided a greater improvement in corneal re-epithelialization than those treated with the standard-of-care, a bandage contact lens. The statistical significance measurement was based on the number of subjects in each arm that achieved complete corneal defect closure three days post refractive surgery. At day 3, 80.2% of eyes receiving the OBG treatment regimen were completely healed compared with 67.0% for standard-of-care. This resulted in a p-value of 0.0203 in favor of OBG. In accordance with FDA standards, a p-value of 0.05 or less demonstrates superiority. As previously disclosed, the study randomized a total of 234 subjects receiving a large 9 mm corneal epithelial wound required for photorefractive keratectomy (“PRK”) surgery. The primary endpoint was masked using a reading center to determine the outcome.
The Company expects to receive additional topline data next week, followed by the full data package in mid-December.
“The proven effectiveness and well tolerated safety profile of EyeGate’s OBG eye drop is a major step for the corneal wound repair market,” stated Vance Thompson M.D., of Vance Thompson Vision in Sioux Falls, SD. “I believe that the OBG eye drop will not only benefit patients with large corneal defects, but also patients with moderate to small corneal abrasions and epitheliopathies.”
“We are thrilled with the results of this pivotal study,” said Stephen From, EyeGate’s CEO. “This allows us to submit a de novo application for commercialization, which we plan to do in the first half of 2020. OBG, if approved, will be the first product indicated to repair corneal defects, as well as the first prescription Hyaluronic Acid (“HA”) eye drop in the U.S., providing a huge opportunity for 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 the treatment of 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 receives FDA approval following successful completion of the PRK pivotal study, 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 trials for patients with PE are 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.
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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 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.
Edison Advisors for EyeGate Pharmaceuticals
SOURCE: EyeGate Pharmaceuticals, Inc.
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