OnPoint Vision Inc. announced in a press release that the FDA has approved phase 2 study expansion of its pivotal Investigational Device Exemption (IDE) study of the AccuraSee intraocular pseudophakic capsular lens (IOPCL) magnifier (MAG) for secondary implantation in the capsular bag with a pre-existing 6 mm acrylic posterior-chamber intraocular lens. 

According to the company, the IOPCL MAG is neutral optic (plano power) with a central +10.0 D 1.8 mm zone and is designed to magnify near images when unilaterally implanted in low-vision pseudophakic subjects with inactive age-related macular degeneration at least 6 months after cataract surgery.

The IOPCL MAG was originally implanted in a first-in-human study in the United States under a separate Early Feasibility Study (EFS) IDE where enrollment and patient follow-up is complete. This EFS IDE study is officially closed, the company said in the press release.