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FDA grants approval for trial for artificial iris

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BOCA RATON, Fla. — The Food and Drug Administration has granted approval for a clinical trial to study an iris reconstruction IOL designed to treat visual problems caused by damaged or congenitally imperfect irides.

Francis Price, MD, of Indianapolis, will be the medical monitor for the study. The multicenter trial plans to enroll patients at 10 centers nationwide.

Ophtec USA, based here, developed the lens.