AcuFocus Receives Approvable Letter From FDA for IC-8 Small Aperture IOL

AcuFocus Receives Approvable Letter From FDA for IC-8 Small Aperture IOL

December 08, 2021

AcuFocus announced that it has received an Approvable Letter from the FDA for its IC-8 small aperture IOL, which is designed for cataract patients.

The letter means that the FDA has completed its review of the IC-8 IOL premarket approval (PMA) application and determined that the PMA substantially meets the requirements of the Food Drug and Cosmetic Act.

According to the letter, the FDA believes it can approve the application following successful completion of pre-approval inspections at the company's manufacturing facilities in the United States and internationally.

In March of 2020, the FDA announced foreign facility inspections would be postponed due to the COVID-19 pandemic. Therefore, AcuFocus anticipated a delay in its overseas manufacturing facility's preapproval production inspections.

“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 CEO for AcuFocus, said in a company news release.

“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.”

Commercialization of the IC-8 IOL in the U.S will begin after successful completion of production facility inspections and receipt of an official FDA approval order, which is expected in Q2 2022, the company said.

The IC-8 IOL is a revolutionary lens that is designed to extend depth of focus providing a clear range of vision at all distances.

The new lens combines a high-quality hydrophobic acrylic aspheric monofocal IOL and wavefront-filtering small aperture technology for cataract patients. Small aperture technologies fill a significant gap in cataract treatment options providing a range of vision across various distances.

The IC-8 IOL lens is approved for use in Europe, Argentina, Singapore, Australia and New Zealand.