EyeGate Pharma Receives Positive Feedback from FDA Regarding Ocular Bandage Gel Packaging
WALTHAM, MA / ACCESSWIRE / June 11, 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 it has received positive feedback from the U.S. Food and Drug Administration ("FDA") regarding the requested packaging for EyeGate's Ocular Bandage Gel ("OBG") eye drop.
OBG is being developed for corneal wound repair post photorefractive keratectomy ("PRK") surgery and for dry eye patients with punctate epitheliopathies ("PE"). OBG does not include a preservative, which can be irritating and exacerbate these ocular surface indications. EyeGate is seeking to use a multi-dose preservative-free ("MDPF") bottle that is more cost effective and less wasteful compared to the standard mono-dose bottle or individual units typically used for preservative-free topical ophthalmics. The FDA has provided EyeGate with a path forward for using the MDPF bottle, requesting that EyeGate complete some additional tests prior to fully approving the bottle for use. These tests are expected to be completed in the second half of 2020 and are not expected to have an impact on EyeGate's cash runway.
"We are very pleased with this positive feedback from the FDA. With their comments, there is a clear path forward for using the multi-dose preservative-free bottle in future clinical studies and ultimately in commercialization," stated Stephen From, EyeGate's Chief Executive Officer. "We believe that using this packaging will dramatically reduce our cost of goods sold, providing us with more financial flexibility as we continue the development of OBG."
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 product is applied as a clear topical gel, to the damaged ocular surface and possesses unique properties that help hydrate, protect, and heal the ocular surface. EyeGate is in the clinic for two different patient populations: (1) photorefractive keratectomy ("PRK") surgery to demonstrate corneal wound repair after refractive surgery; and (2) punctate epitheliopathies ("PE"), specifically in patients with 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 because 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 ("HA") 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 HA eye drop in the U.S. approved for the treatment of Dry Eye.
For more information, please visit www.EyeGatePharma.com.
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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, 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 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
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SOURCE: EyeGate Pharmaceuticals, Inc.
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Released June 11, 2020