FDA Approves Bausch + Lomb’s enVista Envy Intraocular Lens

Bausch + Lomb Corporation, a leading global eye health company, received approval from the U.S. Food and Drug Administration for its enVista Envy full range of vision intraocular lens (IOL), offering a continuous range of vision with excellent dysphotopsia tolerance on the widely used enVista IOL platform.
 
Envy performs in all lighting conditions thanks to ActivSync Optic intelligent energy distribution, which optimizes vision in many lighting conditions. Envy also enables surgeons to treat a wider range of astigmatic patients with more accuracy and precision with 0.5D steps (or less) throughout the cylinder range.
 
“We’re confident that U.S. surgeons will agree with what their Canadian colleagues have already told us: enVista Envy delivers exceptional outcomes and meets cataract patients’ high expectations, as well as their own,” said Anthony Wallace, vice president and general manager, U.S. Surgical, Bausch + Lomb.
 
Bausch + Lomb conducted a randomized and controlled clinical trial evaluating 332 subjects, which demonstrated excellent long-term outcomes with the enVista Envy IOL in the U.S. On average, 86% of patients reported little to no bothersomeness for dysphotopsia (glare, halo, starbursts), showing an impressive tolerance profile overall.¹ 
 
In a Canadian clinical study evaluating 110 subjects, 94% of patients reported little to no difficulty viewing close objects, and 93% were completely to moderately satisfied with their vision post-surgery.²
 
“I’ve long trusted the enVista platform to deliver excellent outcomes for my cataract patients,” said Alice Epitropoulos, MD, Ophthalmic Surgeons & Consultants of Ohio and principal investigator in the Phase 3 U.S. clinical trial. “I expect that having a lens on the same platform that offers a full range of vision with minimal visual disturbances, as well as a toric option for precision astigmatism correction, will significantly enhance my ability to achieve that goal.”
 
The enVista Envy hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia with less than or equal to 1.0 D preoperative corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.
 
The enVista Envy toric hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.
 
enVista Envy IOLs will be commercially available in the U.S. on a limited basis in the coming weeks and more openly available in 2025. Bausch + Lomb is also in the process of seeking regulatory approvals for the lens in additional markets.
 

References: