The company will begin commercialization of the IC-8 small aperture IOL, used for cataract patients, upon successful completion of the manufacturing facility inspections and receipt of an official approval order from the FDA, which the company estimates in Q2 2022.
AcuFocus Inc. announced today it has received an Approvable Letter from the FDA for its IC-8 small aperture IOL for cataract patients.
The letter indicates the FDA has completed its IOL Premarket Approval (PMA) Application and determined that the PMA substantially meets the requirements of the Food Drug and Cosmetic Act, and the FDA believes it can approve the application following successful completion of the pre-approval inspections at the company’s manufacturing facilities in the U.S. and internationally.
In March of 2020, the FDA announced foreign facility inspections would be postponed due to the COVID-19 pandemic.1 As a result of the current environment, AcuFocus anticipated a delay in the pre-approval manufacturing inspections of its international manufacturing facility.
“We are thrilled to receive the approvable letter from the FDA ahead of our MDUFA date and we look forward to working with the FDA to successfully complete these customary pre-approval inspections,” Al Waterhouse, president and chief executive officer for AcuFocus, said in a statement. “The AcuFocus team and our global partners have worked diligently to build a robust, quality management system to ensure that both the integrity of our supply chain and the quality of our devices are maintained.”
The IC-8 IOL is an aspheric monofocal lens that features an embedded filter with a small central aperture. Using wavefront-filtering, small aperture optics, the lens is designed to mitigate the harmful visual effects of unfocused peripheral light, allowing only central light rays to focus on the retina, and deliver continuous extended depth of focus.
Commercialization of the IC-8 IOL in the U.S. will begin upon successful completion of the manufacturing facility inspections and receipt of an official approval order from the FDA, which the company estimates in Q2 2022.