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EyeGate Pharma Confirms Path Forward with FDA To Develop Combination Product

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EyeGate Pharmaceuticals (NASDAQ:EYEG) announced positive feedback from its pre-IND meeting with the FDA regarding the development of MoxiGel, a combination treatment for bacterial conjunctivitis. This product will merge EyeGate's Ocular Bandage Gel with an approved antibiotic. The company aims to complete pre-clinical work and submit an IND by the first half of 2021.

EyeGate's lead product, OBG, is designed to aid ocular surface healing, enhancing treatment for related conditions.

Positive
  • Received positive FDA feedback on MoxiGel development
  • Pathway established for FDA submission of IND for MoxiGel
  • Plans to combine OBG with an approved antibiotic for enhanced treatment
Negative
  • None.

WALTHAM, MA / ACCESSWIRE / August 12, 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 following its pre-IND meeting with the U.S. Food and Drug Administration ("FDA") and has been provided a path forward for the development of MoxiGel, a combination product for the treatment of bacterial conjunctivitis.

The new product will combine EyeGate's Ocular Bandage Gel ("OBG") with an antibiotic that is currently approved for the treatment of bacterial conjunctivitis. EyeGate plans to complete its ongoing pre-clinical work and file an IND for the combination product in the first half of 2021.

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. 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.

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, 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.

Contact

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

SOURCE: EyeGate Pharmaceuticals, Inc.



View source version on accesswire.com:
https://www.accesswire.com/601268/EyeGate-Pharma-Confirms-Path-Forward-with-FDA-To-Develop-Combination-Product

FAQ

What is MoxiGel from EyeGate Pharmaceuticals?

MoxiGel is a combination product being developed by EyeGate Pharmaceuticals for the treatment of bacterial conjunctivitis, combining Ocular Bandage Gel with an approved antibiotic.

When does EyeGate Pharmaceuticals plan to file an IND for MoxiGel?

EyeGate Pharmaceuticals intends to complete its pre-clinical work and file an IND for MoxiGel in the first half of 2021.

What feedback did EyeGate receive from the FDA?

EyeGate received positive feedback from the FDA following its pre-IND meeting, confirming a path forward for MoxiGel development.

What is the significance of the FDA's response to EyeGate?

The FDA's positive response is a crucial step for EyeGate, facilitating the regulatory process necessary to advance MoxiGel toward commercialization.

What is the stock symbol for EyeGate Pharmaceuticals?

The stock symbol for EyeGate Pharmaceuticals is EYEG.

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