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Subsequent Events
6 Months Ended
Jun. 30, 2024
Subsequent Events [Abstract]  
Subsequent Events
15.
Subsequent Events

FDA Warning Letter

On July 12, 2024, the Company received a warning letter from the FDA (Warning Letter) pertaining to YUTIQ® manufacturing, citing alleged violations of cGMP requirements in connection with an FDA inspection at the Company’s Watertown facility in February 2024. The Warning Letter does not represent a final FDA determination of compliance. The Warning Letter requires the Company to implement improvements to the process by which the Company investigates unexplained discrepancies, the implementation of additional written procedures for production and process control, and the adoption of additional control procedures to monitor the output and to validate the performance of manufacturing processes. The Company timely responded to the FDA on August 1, 2024 and is addressing the FDA's observations. Based on current information, the Company believes that the supply of YUTIQ® to patients should not be materially interrupted and that the Company’s other products in development, including DURAVYU, are not impacted by this regulatory action.

Nancy S. Lurker Separation Agreement

On July 10, 2024, Nancy S. Lurker’s term as Executive Vice Chair of the Company expired in accordance with the terms of her Employment Letter Agreement, dated September 16, 2016 and amended on January 3, 2023 and July 10, 2023. Ms. Lurker continues to serve as a member and Vice Chair of the Board of Directors of the Company. On August 6, 2024, Ms. Lurker and the Company entered into a severance agreement and general release (the “Separation Agreement”). Pursuant to the Separation Agreement, subject to Ms. Lurker agreeing to a release of claims and complying with certain other continuing obligations contained therein, the Company will pay Ms. Lurker a lump sum cash payment equal to $0.3 million, less applicable taxes and withholdings.