UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On May 28, 2024, Outlook Therapeutics, Inc. (“Outlook”) announced that the European Commission has granted Marketing Authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) in the European Union (EU). LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU.
The application for European Commission Marketing Authorization of LYTENAVA™ (bevacizumab gamma) is a mixed application grounded on Article 8.3 of Directive 2001/83/EC and is based on the results from Outlook’s wet AMD clinical program, which consists of three completed registration clinical trials – NORSE ONE, NORSE TWO and NORSE THREE – as well as studies and peer reviewed literature substituting or supporting certain tests and studies. This decision applies automatically in all 27 EU Member States and, within 30 days, also to Iceland, Norway and Liechtenstein. Additionally, the Marketing Authorization grants Outlook an initial ten years of market exclusivity in the EU for LYTENAVA™ (bevacizumab gamma).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Outlook Therapeutics, Inc. | ||
| Date: May 28, 2024 | By: | /s/ Lawrence A. Kenyon |
| Lawrence A. Kenyon | ||
| Chief Financial Officer | ||