Bausch + Lomb receives FDA approval for enVista Envy
Bausch + Lomb Corporation, 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 high 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.