OnPoint Vision Inc has initiated enrollment for its phase 1 pivotal clinical trial of the AccuraSee Intraocular Pseudophakic Capsular Lens (IOPCL) Magnifier (MAG).
Let’s start with a company refresh.
Founded in 2019 and based in Aliso Viejo, California, OnPoint Vision is a privately-held ophthalmic medical device company focused on developing and manufacturing specialty intraocular lenses (IOLs) for refractive and low vision applications.
What can you tell me about this IOPCL MAG?
The AccuraSee IOPCL was initially developed as an idea by Kevin J. Cady, OnPoint founder and CEO. The goal: For the IOPCL to be utilized as a solution for delivering a minimally-invasive surgical treatment for pseudophakic patient refractive outcomes—all without the risk of affecting vision quality.
To note, this technology is currently limited to investigational use only in the U.S.
Explain what it is.
The device is a neutral spherical optic fabricated from a biocompatible tested silicon (Biosil). It’s designed to share the space, auto-center, and securely pair with any pre-existing IOL located within the capsular bag.
The purpose: For the AccuraSee to minimize potential risks 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.
What makes it unique for patients?
Quite simply, it’s customizable features.
The lens technology—initially intended for adjusting the refractive error of a pseudophakic eye; however—features a fully reversible platform for both refractive power adjustment and multifocal reversibility.
Plus, it can be personalized for:
- Astigmatic correction
- Cornea symmetry
- Multifocality
- Low vision
How does MAG come into play?
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, according to OnPoint.
To quality, however, patients must have stable age-related macular degeneration (AMD) at least 6 months following cataract surgery.
Any clinical data on it yet?
Back in March 2022, Harvard Eye Associates in Laguna Hills, California, reported implanting the first worldwide AccuraSee to improve near vision in patients with macular degeneration as part of a first-in-human (FIH)investigational device exemption (IDE) study.
And at the moment, a U.S.-based FIH trial is being conducted as part of an early feasibility study (EFS), with patient enrollment completed and follow-up in the process.
Prior to this, however, an EFS 2 study reported that participants, on average, gained 5 lines of near-vision with no changes in distance acuity. No adverse events were reported as well, according to OnPoint.
Gotcha. Now talk about this phase 1 study.
This phase 1 pivotal trial was permitted following the FDA’s approval of OnPoint’s investigational device exemption (IDE) application in November 2023 (see our coverage here).
The study will be evaluating the use of the AccuraSee for secondary implantation within the capsular bag with a pre-existing 6 mm acrylic posterior chamber IOL.
What’s the patient criteria?
Per the company, a total of 50 patients will be enrolled across five locations. Participant criteria includes the following:
- AMD in both eyes
- Aged 55+
- Have had previous cataract surgery at least 6 months prior in both eyes
- Do not have
- Cognitive impairment that may interfere with the ability to make an informed decision
- Glaucoma
- Acute chronic or systemic health issues (such as diabetes)
- Drive at night
Gotcha. So what are the expected outcomes?
The company anticipates 75% of implanted eyes to achieve 10 letters or more at 14 cm compared to baseline best-corrected visual acuity (BCVA) at 30 cm wearing the appropriate distance correction at 24 months.
And the timeframe?
No word yet on this … stay tuned!