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FDA approves clinical study of STAAR’s myopia, astigmatism lenses

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The FDA has approved a human clinical study of STAAR Surgical’s EVO/EVO+ Visian ICL for myopia and the EVO/EVO+ Visian toric ICL for myopia with astigmatism, the company announced in a press release.

Study design modifications, recommended by the FDA in a letter dated Aug. 23, will be incorporated into the investigational plan in a revised submission. The current study plan includes 300 subjects with a primary endpoint at 6 months’ follow-up, the release said.

“STAAR looks forward to working with FDA to incorporate the recommended protocol modifications in order for the study design to support a marketing approval submission,” Caren Mason, STAAR president and CEO, said in the release.