IC-8 IOL submitted for premarket approval
AcuFocus has submitted a premarket approval application to the FDA for its IC-8 small aperture IOL.
The aspheric monofocal lens has an embedded filter with a central aperture. The lens is designed to minimize visual effects stemming from unfocused peripheral light, allowing central light rays to focus on the retina to deliver continuous extended depth of focus, according to a press release.
“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,” Magda Michna, PhD, chief global clinical, medical and regulatory affairs officer at AcuFocus, said in the release.
Safety and effectiveness of the IC-8 were evaluated in a prospective, multicenter, open-label, parallel-group, nonrandomized, examiner-masked, 1-year clinical study.
The trial enrolled 343 study patients and 110 control subjects who were monitored for 12 months. Patients in the study arm received an IC-8 in one eye and a monofocal or monofocal toric IOL in their fellow eye, while those in the control group received monofocal or monofocal toric IOLs in both eyes, the release said.