This article was originally published in The Gray Sheet
Expansion of Implantable Contact Lens (ICL) clinical trials for hyperopia is approved by FDA May 26, the company reports, allowing Monrovia, California-based Staar to begin Phase III trials for the device. Approval of the protocol will allow the firm to expand the study to include patients with as little as 1.5 diopters of hyperopia and reduce the waiting time for patients to receive an ICL in the second eye from six months to 45 days. Additionally, the firm will be allowed to implant an additional 278 ICLs and expand from 14 to 18 sites nationwide
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