Industry

OnPoint Vision Expands Clinical Trial for Investigational Lens Targeting AMD Patients

Eyewire+9h ago2 min read

Key Takeaways OnPoint Vision has advanced its AccuraSee IOPCL MAG into phase 2 clinical trials following completion of a successful early feasibility study in the US The investigational lens is designed to improve near vision in pseudophakic patients with inactive AMD by providing targeted magnification through a specialized central optical zone Originally developed for post-cataract refractive correction, the IOPCL platform is evolving into a broader solution for vision enhancement OnPoint Vision has announced the expansion of its approved Investigational Device Exemption (IDE) study to initiate phase 2 of its pivotal clinical trial evaluating the AccuraSee Intraocular Pseudophakic Capsular Lens (IOPCL) Magnifier (MAG). The study will assess the safety and effectiveness of the IOPCL MAG when used as a secondary implant in the capsular bag of patients who already have a 6mm acrylic posterior chamber IOL. The device is specifically designed for pseudophakic patients with low vision due to inactive age-related macular degeneration (AMD), at least 6 months following cataract surgery. The AccuraSee IOPCL MAG features a neutral optic (plano power) design with a central +10.0 diopter, 1.8mm optical zone. This configuration is intended to provide magnification of near images when implanted unilaterally, potentially improving functional vision in patients with limited treatment options. The advancement to phase 2 follows the successful completion of a First-in-Human (FIH) study conducted in the United States under a separate Early Feasibility Study (EFS) IDE. According to the company, enrollment and patient follow-up for the EFS study have been completed, and the study has been officially closed. “This milestone reflects our continued commitment to addressing unmet needs in patients with vision loss due to AMD,” said Kevin J. Cady, CEO and President of OnPoint Vision. “We are encouraged by the progress to date and look forward to advancing clinical validation of this novel approach.” Founded in 2019, OnPoint Vision's IOPCL platform was originally designed to correct residual refractive errors following cataract surgery but has since evolved into a versatile system with broader applications in pseudophakic vision correction.

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AI Summary

Quick Take

OnPoint Vision has initiated a Phase 2 pivotal trial for its AccuraSee IOPCL MAG, a secondary intraocular lens designed to restore near vision in pseudophakic patients with inactive AMD. The device features a +10.0 D central optical zone on a plano carrier and is implanted unilaterally into the capsular bag alongside an existing 6mm acrylic IOL.

Why It Matters

Managing low vision in AMD patients who have already undergone cataract surgery remains a significant clinical challenge with limited surgical interventions. This 'piggyback' approach is notable because it utilizes the existing capsular bag to provide high-powered magnification without requiring a complex IOL exchange or reliance on external low-vision aids. If successful, it offers a permanent, intraocular solution for functional near-vision enhancement in a population that often struggles with standard magnification tools.

Key Details

The AccuraSee IOPCL MAG is designed as a secondary implant to be placed in the capsular bag with an existing 6mm acrylic posterior chamber IOL.
The lens features a 1.8mm central optical zone providing +10.0 diopters of add power, while the surrounding optic remains plano (neutral).
The device is intended for unilateral implantation to provide targeted magnification for near tasks while maintaining the existing distance correction.
The platform was originally developed for post-cataract refractive correction before being adapted for AMD-related low vision applications.
The transition to Phase 2 follows the successful completion and closure of a First-in-Human Early Feasibility Study (EFS) in the United States.

Study Snapshot

Design

Phase 2 Pivotal Clinical Trial (IDE expansion)

Population

Pseudophakic patients with low vision due to inactive AMD, at least 6 months post-cataract surgery

Practice Implications

Clinicians should monitor this technology as a potential 'interventional low vision' option for stable AMD patients who are dissatisfied with their near-vision performance post-cataract surgery. This approach moves optical magnification from the spectacle plane to the intraocular plane, potentially offering a more consistent and convenient solution for patients with central vision loss.

Who's Affected

Cataract SurgeonsRetina SpecialistsLow Vision SpecialistsOptometrists

What's Next

OnPoint Vision will proceed with enrollment for the Phase 2 pivotal trial to further validate the safety and effectiveness of the lens, which will be critical for future regulatory submissions and potential commercialization.

Evidence StrengthPreliminary

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