AcuFocus Receives IDE Approval from the FDA to Begin Clinical Study of the IC-8 Lens

AcuFocus announced that it has received approval for an investigational device exemption (IDE) from the FDA to conduct a pivotal study of the company’s IC-8 small aperture IOL for patients with cataracts.

The AcuFocus IC-8 IOL is a clear monofocal lens with an embedded mini-ring or pinhole in the center. This novel lens is designed to increase a patient’s natural range of vision by extending thefocus of light rays that enter the eye.

“Studies performed outside the United States have shown that the IC-8 lens delivers reliable extended depth of focus with high levels of patient satisfaction,” Al Waterhouse, AcuFocus Chief Executive Officer, said in a company news release. “Achieving IDE approval was the next critical milestone for the company as we seek premarket approval in the United States.”

The goal of this prospective, multicenter, parallel-group study is to demonstrate the extended depth of focus achieved with the IC-8 IOL when compared with traditional monofocal IOLs. The study will enroll approximately 475 patients with bilateral cataracts. Participants will be followed for 12 months and evaluated for improvement in their vision at all distances.