ClarVista Medical, Inc., a privately-held ophthalmic device company developing the HARMONI Modular IOL System — a novel intraocular lens (IOL) used to restore vision after cataract surgery — recently announced several feasibility trials for the IOL have been fully enrolled with promising follow-up results.
According to ClarVista, a series of feasibility trials with more than 175 patients have now been fully enrolled with promising results from preliminary analyses. With the feasibility trial enrollment completed, the company's body of evidence now reportedly consists of more than 250 patients, some with up to three years of follow-up.
Longer-term results from these feasibility trials will reportedly be analyzed as the HARMONI Modular IOL moves towards a U.S. pivotal trial. The company reportedly plans to submit an investigational device exemption (IDE) in pursuit of U.S. FDA approval in the second quarter of 2017.
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Source: ClarVista Medical, Inc.