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IOLs

Premarket approval for IC-8 IOL submitted to FDA

Posted on March 2, 2021

A Premarket Approval application has been submitted to the U.S. Food and Drug Administration for IC-8 small aperture IOL (AcuFocus, Inc), according to a press release.

The safety and efficacy of IC-8 IOL was investigated in a prospective, multicenter, open-label, parallel-group, nonrandomized, examiner-masked, one-year clinical study. In the study, 343 patients had an IC-8 IOL implanted in one eye and a control (monofocal or monofocal toric) IOL implanted in their fellow eye while 110 participants in the control group were bilaterally implanted with monofocal or monofocal toric IOLs.

“The IC-8 IOL is a first-of-its-kind presbyopia-correcting lens that is designed to deliver seamless visual acuity from near to far without the ‘blurry zones’ found in traditional lens designs,” said Magda Michna, PhD, Chief Global Clinical, Medical & Regulatory Affairs Officer, AcuFocus in a press release. “We are incredibly grateful to our investigators, their teams and the patients who participated in the study. Their commitment to the study integrity and follow-up timelines, especially during a global pandemic, helped us to achieve this critical milestone. We look forward to working with the FDA as they review our submission and results.”

Read the full press release here.

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