PRESS RELEASE
ALISO VIEJO, Calif., May 12, 2023, OnPoint Vision Inc, a privately held ophthalmic medical device company, announced the filing of their Investigational Device Exemption (IDE) application to begin their pivotal clinical trial of the Intraocular Pseudophakic Capsular Lens (IOPCL) Magnifier (MAG) aka “CADY” study for secondary implantation in the capsular bag with a pre-existing posterior chamber intraocular lens (IOL). The IOPCL MAG is neutral optic (Plano power) with a central +10.0D 1.8mm zone designed to magnify near images when unilaterally implanted in low vision (BCDVA 20/63 to 20/160) pseudophakic subjects with stable Age-Related Macular Degeneration (AMD) at least after cataract surgery. The IOPCL MAG was originally implanted in First in Human (FIH) study in the US under a separate Early Feasibility Study (EFS) IDE.
OnPoint Vision also announced the FDA conditional approval of a refractive EFS IDE to evaluate the initial safety and effectiveness of the monofocal IOPCL for secondary implantation in the capsular bag to improve near and/or intermediate vision by inducing myopia (monovision) when implanted in the non-dominant eye in up to ten (10) pseudophakic subjects following at least 6 months after previous cataract surgery. This will be the second EFS study of the IOPCL, where the FIH study of the monofocal IOPCL was conducted in low vision subjects. This study was completed and closed under a separate EFS IDE.
About the Technology
OnPoint was founded in 2019, the founder and inventor of this technology, Kevin J. Cady, CEO and President has been involved in innovative ophthalmic products for the past 30-years. The IOPCL (Intraocular Pseudophakic Capsular Lens), was originally designed to correct post-cataract residual refractive errors. However, it quickly became apparent that this lens platform could be used for a variety of pseudophakic refractive applications.