Staar Surgical Gains Key FDA Approval to Broaden Patient Eligibility

Staar Surgical has secured a significant regulatory victory in its core U.S. market. The Food and Drug Administration (FDA) has granted a substantial expansion of the approved age range for the company's EVO and EVO+ implantable collamer lenses (ICLs). This move dramatically increases the size of the addressable patient population. The development arrives as the broader refractive surgery sector undergoes a notable shift in treatment preferences.

The FDA's updated authorization represents a pivotal change. Previously, Staar Surgical's EVO/EVO+ Visian ICLs were indicated for U.S. patients aged 21 to 45 years. The new clearance now extends eligibility to individuals up to 60 years old. This decision was supported by three years of clinical study data demonstrating the long-term safety profile of the implants.

By widening the age indication, the company aims to capture a much larger segment of the U.S. population seeking vision correction. This step aligns with a global corporate strategy focused on increasing the adoption of its proprietary lens technology as an alternative to established procedures.

Shifting Dynamics in Vision Correction

This regulatory milestone coincides with a transformative period for the refractive surgery market in the United States. Demand for traditional laser-based procedures, which reshape the cornea by removing tissue, has contracted sharply. Over the past three years, these treatments have seen a decline of nearly 40%, reaching a multi-year low.

In contrast, implantation rates for Staar Surgical's EVO ICL models have shown recent growth. The company's procedure offers a distinct advantage: it does not require the removal of corneal tissue or the eye's natural lens. The latest FDA endorsement strengthens Staar's competitive positioning within this expanding niche against weakening laser surgery alternatives.

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Leadership in a Period of Transition

Alongside this operational progress, Staar Surgical is navigating an internal leadership change. Since February 1, Warren Foust and Deborah Andrews have been serving as interim Co-CEOs. This management shift followed the termination of a proposed merger with Alcon in January 2026, which did not proceed due to a lack of necessary shareholder approval.

Upcoming quarterly financial reports will provide the first indicators of how effectively the new executive team can leverage the broader FDA approval to drive concrete revenue growth. A key focus for observers will be whether rising acceptance of ICL technology can sustainably offset the broader downward trend in the vision correction sector.

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