FDA Approves Bausch + Lomb's enVista Envy IOL for Full Range Vision Correction
Key Insights
The FDA has approved Bausch + Lomb (search)'s enVista Envy (search) IOL, offering a continuous range of vision and excellent dysphotopsia tolerance for cataract (search) patients.
Clinical trials showed 86% of patients reported minimal issues with dysphotopsia, such as glare and halos, after receiving the enVista Envy (search) IOL.
A Canadian study revealed that 94% of patients experienced little difficulty viewing close objects, with 93% satisfied with their vision post-surgery.
The U.S. Food and Drug Administration (FDA) has approved Bausch + Lomb (search)'s enVista Envy (search) full range of vision intraocular lens (IOL), marking a significant advancement in cataract (search) surgery options. The enVista Envy IOL is designed to provide patients with a continuous range of vision while minimizing dysphotopsia, unwanted visual disturbances such as glare, halos, and starbursts.
Clinical Trial Outcomes
A multicenter, randomized, and controlled clinical trial involving 332 subjects demonstrated excellent long-term outcomes with the enVista Envy (search) IOL in the U.S. The results showed that, on average, 86% of patients reported little to no bothersomeness from dysphotopsia. These findings highlight the lens's impressive tolerance profile and potential to improve patient satisfaction post-cataract (search) surgery.
In a Canadian clinical study, 94% of patients reported little to no difficulty viewing close objects, and 93% were completely to moderately satisfied with their vision following the procedure. These outcomes underscore the lens's ability to deliver on patient expectations for improved vision quality across various distances.
ActivSync Optic Technology
The enVista Envy (search) IOL incorporates ActivSync Optic intelligent energy distribution, optimizing vision in diverse lighting conditions. This technology ensures outstanding performance, enabling surgeons to treat a broader range of astigmatic patients with greater accuracy and precision using 0.5D steps or less throughout the cylinder range.
Surgeon's Perspective
Alice Epitropoulos, MD, Ophthalmic Surgeons & Consultants of Ohio and principal investigator in the Phase 3 U.S. clinical trial, stated, "I’ve long trusted the enVista platform to deliver excellent outcomes for my cataract (search) patients. 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 (search) correction, will significantly enhance my ability to achieve that goal."
Availability
enVista Envy (search) IOLs will be commercially available in the U.S. on a limited basis in the coming weeks and more broadly in 2025. Bausch + Lomb (search) is also pursuing regulatory approvals for the lens in additional markets, expanding its potential reach to more patients worldwide.
Indications and Safety Information
The enVista Envy (search) 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 (search) following removal of a cataractous lens to mitigate the effects of presbyopia (search) by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.
The enVista Envy (search) 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 (search) following removal of a cataractous lens to mitigate the effects of presbyopia (search) by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.
Physicians should carefully weigh the potential risks and benefits before implanting the enVista Envy (search) lens, considering the circumstances and conditions outlined in the Instructions for Use labeling. Patients may experience some visual disturbances due to the superposition of focused and unfocused multiple images, including halos, starbursts, glare, double vision, haziness, and blurred vision. A reduction in contrast sensitivity compared to a monofocal IOL may also occur. As with other trifocal IOLs, there is a possibility that visual disturbances may be significant enough that the patient will request explant of the IOL.