Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company, has announced that the U.S. Food and Drug Administration (FDA) has approved the enVista® Envy™ intraocular lens (IOL), which provides a continuous range of vision with excellent tolerance for dysphotopsia, building on the established enVista IOL platform.
“We are confident that U.S. surgeons will echo the positive feedback we’ve received from their Canadian counterparts: enVista Envy offers exceptional outcomes that meet the high expectations of cataract patients,” said Anthony Wallace, vice president and general manager of U.S. Surgical at Bausch + Lomb.
A multicenter, randomized controlled trial involving 332 participants demonstrated strong long-term results for the enVista Envy IOL in the U.S. On average, 86% of patients reported minimal bothersomeness from dysphotopsia (such as glare and halos), showcasing an impressive tolerance profile. In a separate Canadian study of 110 subjects, 94% reported little to no difficulty with near vision, and 93% were satisfied with their vision post-surgery.
The enVista Envy IOL features ActivSync Optic technology, optimizing vision across various lighting conditions. Additionally, it allows surgeons to treat a broader range of astigmatic patients with enhanced precision, utilizing 0.5D steps (or less) throughout the cylinder range.
“I have always trusted the enVista platform for excellent cataract outcomes,” said Dr. Alice Epitropoulos, principal investigator in the Phase 3 U.S. clinical trial. “With the addition of a lens offering a full range of vision and minimal visual disturbances, along with a toric option for precise astigmatism correction, I can better achieve optimal results for my patients.”
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 approvals for the lens in additional markets.
Indications and Important Safety Information
The enVista Envy hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients to correct aphakia with ≤1.0 D preoperative corneal astigmatism following cataract removal. It aims to mitigate presbyopia effects by improving intermediate and near visual acuity while maintaining distance vision comparable to an aspheric monofocal IOL.
The enVista Envy toric hydrophobic acrylic IOL is similarly indicated for primary implantation to correct aphakia and corneal astigmatism, offering improved intermediate and near vision while preserving distance acuity.
