Company: STAA
Filing Date: 2025-05-16
Form Type: 8-K
Source: 0000950170-25-073099
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Company: STAAR SURGICAL CO
Filing Date: 2025-05-16
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Events.

Share Repurchase Authorization

On May 16, 2025, STAAR Surgical Company (the “ Company”) issued a press release announcing that its Board of Directors had authorized a share repurchase program under which the Company may repurchase up to $30 million of its outstanding common stock. Under the program, the Company may repurchase shares in the open market, through privately negotiated transactions, by entering into structured repurchase agreements with third parties, by making block purchases, and/or pursuant to Rule 10b5-1 trading plans. The timing, manner, price, and amount of any repurchases under the program will be determined by the Company in its discretion, subject to market conditions, legal requirements, and other considerations. The Company is not obligated to repurchase any specific number of shares, and the program may be modified, suspended, or discontinued at any time, without prior notice. The share repurchase program is expected to continue over the next six months, unless extended or shortened by the Board of Directors. A copy of the press release announcing the share repurchase program is attached hereto as Exhibit 99.1.

China Regulatory Approval

On May 14, 2025, the National Medical Products Administration (NMPA) in China approved the Company’s EVO+ Toric Implantable Collamer Lens (EVO+ TICL) for marketing and sale in China. The EVO+ TICL is indicated for use in phakic eye treatment in patients 21-45 years of age for the correction and reduction of myopia in patients ranging from -0.5D to -18.0D with less than or equal to 6.0D of astigmatism. The Company has been marketing and selling its EVO ICL (toric and spheric) in China since 2014. The EVO+ ICL, which has a larger optical zone than the EVO ICL, was approved by the U. S. FDA in March 2022. The Company has also submitted an application with the NMPA for its EVO+ spheric ICL, which remains pending. As previously disclosed, the Company has been working to ready its Switzerland manufacturing facility for production of EVO and EVO+ ICLs for marketing and sale in China. The Company’s ability to produce ICLs in Switzerland for China remains subject to manufacturing validations and receipt of all required approvals.

The information furnished herewith pursuant to Item 8.