drugset / Press release

EyeGate Files Supplement to Investigational Device Exemption to Commence Study in Punctate Epitheliopathy using the EyeGate Ocular Bandage Gel

2018-05-30 · Kiora Pharmaceuticals, Inc. · original kiorapharma.com ↗

Continued Expansion of the EyeGate OBG Franchise 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. About EyeGate 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. 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 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. Contact Joseph Green / Andrew Gibson Edison Advisors for EyeGate Pharmaceuticals 646-653-7030 / 7019 [email protected] / [email protected] Source: EyeGate Pharmaceuticals, Inc. Released May 30, 2018 email Email Alerts location_city Company Profile contact_page Contacts rss_feed RSS News Feed account_tree Sitemap © 2026 Kiora Pharmaceuticals, Inc. All Rights Reserved. Privacy Policy Disclaimer Sitemap Accessibility Statement We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent. Cookie Settings Accept All Manage consent Close Privacy Overview This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience. Necessary Necessary Always Enabled Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously. Cookie Duration Description cookielawinfo-checkbox-analytics 11 months This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics". cookielawinfo-checkbox-functional 11 months The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". cookielawinfo-checkbox-necessary 11 months This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary". cookielawinfo-checkbox-others 11 months This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. cookielawinfo-checkbox-performance 11 months This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance". viewed_cookie_policy 11 months The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data. Functional Functional Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. Performance Performance Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. Analytics Analytics Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. Advertisement Advertisement Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads. Others Others Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. SAVE & ACCEPT

The release as fetched from its publisher. kiorapharma.com ↗