The U.S. Food and Drug Administration has expanded the approved age range for STAAR Surgical’s EVO ICL (Implantable Collamer Lens), allowing the vision correction device to be used in patients as young as 21, according to regulatory filings reviewed by SourceRated. The decision follows a supplemental clinical data submission from the California-based ophthalmic device manufacturer.
The EVO ICL, a surgically implanted lens that corrects myopia and astigmatism, previously carried FDA approval for patients aged 21-45. The new indication removes the upper age limit while maintaining the 21-year minimum. “This expansion reflects our confidence in the long-term safety profile,” noted an FDA official speaking on background about the March 22 decision.
Analysts suggest the move could increase STAAR’s addressable market by approximately 15 million U.S. adults. The company reported $90.2 million in Q4 2023 ICL sales, representing 28% year-over-year growth. “Demographic trends favor refractive surgery adoption as younger generations prioritize discretionary health spending,” said a medical devices analyst at Piper Sandler.
Ophthalmologists caution that patient selection remains critical. “While the technology is proven, not all corneas are suitable for this permanent implantation,” advised Dr. Sarah Chen, a refractive surgeon at Johns Hopkins Wilmer Eye Institute. The FDA maintains its requirement for comprehensive pre-operative testing.
Industry observers anticipate increased competition in the premium refractive surgery segment, with Alcon and Johnson & Johnson expected to accelerate competing product development timelines.