1 week ago
The U.S. Food and Drug Administration (FDA) on Tuesday approved an expanded age indication for Staar Surgical Company’s (NASDAQ:STAA) EVO/EVO+ Visian Implantable Collamer Lenses (ICL). The stock is trading higher in the premarket.
The EVO ICL was previously approved for U.S. patients 21 to 45 years old.
The FDA has approved an expanded age indication for the EVO ICL, allowing its use for patients aged 21 to 60 years old, which could potentially add nearly 8 million refractive patients to the market.
The approval follows the release of three-year clinical trial safety data, reinforcing the long-term safety profile of the EVO ICL.
Patient Preference
In the U.S., the EVO ICL has become the leading procedure for patients with -8.0 diopters and above, as laser-based procedures are declining significantly.
Recent studies indicate that over half of U.S. vision correction consumers are now interested in alternatives to LASIK, reflecting a shift in patient preferences towards lens-based solutions.
Long-Term Safety
In the FDA clinical trial, 629 eyes were followed for three years, demonstrating a strong safety ...
