The FDA has approved OnPoint Vision Inc’s investigational device exemption (IDE) application to launch its phase 1 pivotal clinical trial of the AccuraSee Intraocular Pseudophakic Capsular Lens (IOPCL) Magnifier (MAG).
Refresh me on OnPoint Vision.
Based in Aliso Viejo, California, OnPoint Vision was founded in 2019 as a privately-held ophthalmic medical device company focused on developing and manufacturing specialty intraocular lenses (IOLs) for refractive and low vision applications.
And this AccuraSee IOPCL?
OnePoint Vision’s Founder and CEO Kevin J. Cady developed the idea for the AccuraSee IOPCL as a solution for delivering a minimally-invasive surgical treatment—without potentially affecting vision quality—for refractive outcomes of a pseudophakic patient, according to the company.
To note, this technology is currently limited to investigational use only in the U.S.
So what is it, exactly?
As a neutral spherical optic fabricated from a biocompatible tested silicon (Biosil), the AccuraSee is designed to share the space, auto-center, and securely pair with any pre-existing IOL located within the capsular bag.
This purpose of the device is to minimize “inherent risk associated with sulcus placed lens platforms,” according to the company, such as recurrent iridocyclitis, cystoid macular edema (CME), vitreous hemorrhage, and uveitis-glaucoma-hyphema (UGH) syndrome.
Is it customizable?
Per OnPoint Vision, yes.
While the lens technology was initially intended for adjusting the refractive error of a pseudophakic eye, the platform is fully reversible (for both refractive power adjustment and multifocal reversibility) and can be personalized to enable the following:
- Astigmatic correction
- Cornea symmetry
- Multifocality
- Low vision
Explain the MAG portion of this.
Per the company, the AccuraSee IOPCL MAG is a neutral optic (plano power) with a central +10.0D 1.8mm zone designed to magnify near images when unilaterally implanted in low-vision pseudophakic patients.
To note, these patients must also have stable age-related macular degeneration (AMD) at least 6 months following cataract surgery.
Has it been clinically tested yet?
That’s ongoing, actually.
A first-in-human (FIH) trial is currently ongoing in the U.S. as part of an early feasibility study (EFS)—a limited clinical investigation of a device early in development—in which the IOPCL MAG was implanted.
Update on that: patient enrollment is complete and patient follow-up is ongoing (so stay tuned!).
Wait… what’s the difference between an FIH trial and EFS?
Good question! Information gathered during an EFS can aid in determining any device modifications. Further, an EFS doesn’t necessarily mean it’s the first clinical use of a device.
Comparatively, a FIH study includes the evaluation of a device for the very first time in human participants, according to the FDA.
Now what about this new phase 1 trial?
As part of this new IDE acceptance, the company will assess the AccuraSee IOPCL MAG for secondary implantation within the capsular bag with a pre-existing 6 mm acrylic posterior chamber IOL.
Gotcha. Any other updates to know about?
Just one more! OnPoint Vision also received FDA approval for its third refractive EFS IDE in order to assess the safety and efficacy of the AccuraSee IOPCL (monofocal) for secondary implantation in the capsular bag.
The goal: to improve near and/or intermediate vision via inducing myopia (monovision) when implanted in the non-dominant eye in as many as 10 pseudophakic subjects following at least 6 months after previous cataract surgery,
To note, this is the second EFS for the IOPCL (monofocal). A previous FIH was conducted in low-vision patients.