AUS
NZ
UK
CA
USA
IND
Highlights
- New enVista Envy IOL offers a continuous range of vision and improved patient satisfaction.
- Clinical trials demonstrate excellent outcomes with high tolerance for visual disturbances.
- Limited availability in the U.S. soon, with broader launch planned for 2025.
Bausch + Lomb Corporation, a global leader in eye health, has announced a significant milestone with the U.S. Food and Drug Administration's approval of the enVista® Envy™ intraocular lens (IOL). This innovative lens is designed to provide a continuous range of vision while ensuring excellent tolerance for dysphotopsia, marking a promising advancement in cataract surgery.
The enVista Envy lens builds upon the widely accepted enVista IOL platform, which has already garnered a reputation for delivering outstanding patient outcomes. Anthony Wallace, vice president and general manager of U.S. Surgical at Bausch + Lomb, expressed confidence in the lens's potential impact, stating, “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.”
Clinical trials validating the enVista Envy lens involved a multicenter, randomized, controlled study with 332 participants. The results were promising, with an impressive 86% of patients reporting little to no bothersomeness related to dysphotopsia, including issues like glare and halos. Further trials conducted in Canada revealed even more encouraging outcomes, with 94% of patients indicating little difficulty in viewing close objects post-surgery and 93% expressing satisfaction with their vision.
A key feature of the enVista Envy IOL is its ActivSync Optic technology, which intelligently distributes energy to optimize vision across various lighting conditions. This innovation allows surgeons to treat a broader range of astigmatic patients with enhanced accuracy, providing 0.5D steps or less throughout the cylinder range. Dr. Alice Epitropoulos, an ophthalmologist and principal investigator in the Phase 3 U.S. clinical trial, highlighted the lens’s potential benefits, saying, “I expect that having a lens on the same platform that offers a full range of vision with minimal visual disturbances will significantly enhance my ability to achieve that goal.”
The enVista Envy IOLs are expected to be available in the U.S. on a limited basis in the coming weeks, with a broader rollout planned for 2025. Bausch + Lomb is actively pursuing regulatory approvals for the lens in additional markets, signaling its commitment to expanding access to this groundbreaking technology.
Indications for the enVista Envy IOL include primary implantation in the capsular bag for adult patients to correct aphakia and mitigate presbyopia effects, ultimately improving both intermediate and near visual acuity while maintaining distance vision comparable to traditional aspheric monofocal IOLs.
