What regulatory approvals and potential antitrust challenges could affect the completion of the merger and its timing?

Regulatory landscape and antitrust risk

The STA — Alcon combination will have to clear the usual suite of merger filings in the United States, Europe and any other jurisdictions where the two companies have material sales. In the U.S. the transaction will be subject to review by the Federal Trade Commission (FTC) under the Hart‑Scott‑Rodino Act, and the DOJ’s Antitrust Division could intervene if the merged entity is judged to give it a dominant share of the global market for phakic intra‑ocular lenses (ICLs) and related ophthalmic surgical devices. In Europe the European Commission’s Competition Directorate‑General will conduct a “Phase I” assessment, and, given the relatively high concentration in the premium ICL segment, a “Phase II” deep‑dive is possible. Parallel reviews are likely in Japan (JFTC) and China (SAMR), where both Alcon and STAAR have growing commercial footprints.

Because the merger pairs the world‑leader in EVO ICLs with Alcon’s broader ophthalmic platform, antitrust concerns centre on: (1) the combined share of the premium ICL market (potentially > 50 % globally); (2) the ability to bundle ICLs with Alcon’s surgical consumables, which could foreclose rivals; and (3) cross‑border “vertical” effects in the supply chain for ophthalmic devices. If the regulators deem the deal “potentially anti‑competitive,” they could require divestitures of specific product lines (e.g., Alcon’s own ICL portfolio) or impose behavioural remedies that would lengthen the closing timeline. Historically, similar ophthalmic mergers have taken 6‑9 months from filing to clearance, and a “Phase II” probe can add another 3‑4 months. Consequently, investors should price in a material‑event risk window extending into late 2025 or early 2026; a delay or conditional divestiture could compress the 51 %‑59 % premium that STAAR shareholders are currently being offered.