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Home » Eyegate sees top-line corneal wound win as unlocking path to U.S. de novo filing
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Eyegate sees top-line corneal wound win as unlocking path to U.S. de novo filing

Nov. 22, 2019
By Michael Fitzhugh
Shares of Eyegate Pharmaceuticals Inc. (NASDAQ:EYEG) rose 54.8% to $7.09 Friday on news that its ocular bandage gel (OBG) proved superior to standard of care in healing corneal wounds following photorefractive keratectomy (PRK) surgery. The pivotal top-line data will allow the Waltham, Mass.-based company to submit a de novo application to the FDA for commercialization in the first half of 2020, said CEO Stephen From. If approved, the OBG eye drop would be the first product indicated to repair corneal epithelial defects, as well as the first prescription hyaluronic acid (HA) eye drop in the U.S., creating new competition for widely used bandage contact lenses (BCL).
BioWorld MedTech Regulatory Ocular De novo

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