Bausch + Lomb Corporation (NYSE/TSX: BLCO), a global leader in eye health, has announced that the U.S. Food and Drug Administration has approved the enVista® Envy™ intraocular lens (IOL). This new lens offers a full range of vision with superior tolerance to dysphotopsia (visual disturbances such as glare, halos, and starbursts) and is built on the popular enVista IOL platform.
“We believe U.S. surgeons will find that enVista Envy meets cataract patients’ high expectations, as our Canadian colleagues have already reported,” said Anthony Wallace, vice president and general manager of U.S. Surgical at Bausch + Lomb.
Clinical trials conducted in the U.S. with 332 participants showed excellent long-term results for the enVista Envy IOL. Approximately 86% of patients reported minimal to no issues with dysphotopsia.1 In Canada, a study with 110 participants found that 94% of patients had little to no difficulty seeing close objects, and 93% were satisfied with their vision after surgery.2
The Envy lens performs well in various lighting conditions due to its ActivSync Optic technology, which intelligently distributes energy to optimize vision. Additionally, it allows surgeons to treat a broader range of astigmatic patients with greater accuracy, using smaller increments (0.5D or less) in the cylinder range.
“I’ve relied on the enVista platform to deliver great outcomes for my cataract patients,” said Dr. Alice Epitropoulos, an ophthalmologist at Ophthalmic Surgeons & Consultants of Ohio and the principal investigator in the Phase 3 U.S. trial. “The addition of a lens that provides a full range of vision with minimal visual disturbances, plus a toric option for astigmatism correction, will significantly enhance patient outcomes.”
The enVista Envy IOLs will be available on a limited basis in the U.S. in the coming weeks, with broader availability expected in 2025. Bausch + Lomb is also pursuing regulatory approval for the lens in other markets.
Indications and Safety Information
The enVista Envy hydrophobic acrylic IOL is designed for primary implantation in adult patients’ capsular bags to correct aphakia (absence of the eye’s natural lens) after cataract removal. It is suitable for patients with up to 1.0 D of preoperative corneal astigmatism and aims to improve intermediate and near vision while maintaining distance vision comparable to a monofocal IOL.
The enVista Envy toric IOL is indicated for adult patients with aphakia and corneal astigmatism following cataract surgery, providing similar visual benefits.
