VAUGHAN, Ontario—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 full range of vision intraocular lens (IOL), which offers what the company describes as a continuous range of vision with excellent dysphotopsia tolerance on the widely used enVista IOL platform. “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.

A multicenter, randomized and controlled clinical trial evaluating 332 subjects demonstrated excellent long-term outcomes with the enVista Envy IOL in the U.S, the company reported. On average, 86 percent of patients reported little to no bothersomeness for dysphotopsia (glare, halo, starbursts), showing an impressive tolerance profile overall., Bausch + Lomb  said. In a Canadian clinical study evaluating 110 subjects, 94 percent  of patients reported little to no difficulty viewing close objects, and 93 percent were completely to moderately satisfied with their vision post-surgery, the company noted.

According to the announcement, Envy delivers outstanding performance in all lighting conditions due 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.

“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 company said that enVista Envy IOLs will be commercially available in the U.S. on a limited basis in the coming weeks and more broadly in 2025. Bausch + Lomb said it is also in the process of seeking regulatory approvals for the lens in additional markets.