FDA Approves Bausch + Lomb's enVista Envy Full Range of Vision IOL
Bausch + Lomb announced that the FDA has approved the enVista Envy full range of vision IOL. The new lens is built on the enVista IOL platform and is designed to offer patients a continuous range of vision while providing excellent tolerance for dysphotopsia.
“We’re confident that US 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,” Anthony Wallace, vice president and general manager of U.S. Surgical at Bausch + Lomb, said in a company news release.
A US-based multicenter, randomized, and controlled clinical trial involving 332 subjects demonstrated excellent long-term results with the enVista Envy IOL[1]. The trial revealed that 86% of patients experienced little to no bothersome dysphotopsia, such as glare, halos, or starbursts. A separate Canadian study involving 110 subjects showed that 94% of patients had minimal difficulty viewing close objects, and 93% expressed moderate to complete satisfaction with their vision post-surgery[2].
According to B+L, the enVista Envy IOL delivers outstanding performance across various lighting conditions, thanks to its ActivSync Optic intelligent energy distribution technology. This feature optimizes vision in multiple lighting scenarios. Additionally, the IOL allows surgeons to treat a broader range of astigmatic patients with enhanced accuracy, offering adjustments in 0.5D steps or smaller throughout the cylinder range.
The enVista Envy IOL will be available in the US on a limited basis in the coming weeks, with a broader rollout planned for 2025. Bausch + Lomb is also actively seeking regulatory approvals for the lens in additional markets worldwide.
References
- Data on file. enVista Envy U.S. Clinical Study.
- Data on file. enVista Envy Canadian Clinical Study.