FDA approves Bausch + Lomb’s enVista Envy range of IOLs

(Image credit: Adobe Stock/Olivier de Moal)

Bausch + Lomb Corp announced the FDA has granted approval the enVista Envy full range of vision IOLs, which offers a continuous range of vision with 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,” Anthony Wallace, vice president and general manager, U.S. Surgical, Bausch + Lomb, said in a news release.¹

According to the company, a multicenter, randomly assigned and controlled clinical trial evaluating 332 subjects conducted in the United States demonstrated excellent long-term outcomes with the enVista Envy IOL. On average, 86% of patients included in the study reported little to no problem with glare, halo or starbursts.

Earlier this year, A Canadian study evaluated 110 subjects, and 94% of patients reported little to no difficulty viewing close objects, and 93% were completely to moderately satisfied with their vision post-surgery.²

The enVista Envy features ActivSync Optic Intelligent Energy Distribution, which optimizes vision in every lighting condition, and ClearPath technology, which helps reduce light scattering, according to Bausch + Lomb.

“I’ve long trusted the enVista platform to deliver excellent outcomes for my cataract patients,” Alice Epitropoulos, MD, Ophthalmic Surgeons & Consultants of Ohio and principal investigator in the Phase 3 U.S. clinical trial, said in a statement. “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.”

According to Bausch + Lomb, 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 is also in the process of seeking regulatory approvals for the lens in additional markets.

The company noted the enVista Envy 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 following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.¹

Moreover, the company noted its enVista Envy 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 following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.¹

References

1. Bausch + Lomb Receives FDA Approval for enVista® Envy Full Range of Vision Intraocular Lens. Bausch + Lomb. Pulbished October 14, 2024. Accessed October 14, 2024. https://www.bausch.com/news/?id=231

2. Martin David Harp. enVista Envy by Bausch + Lomb approved by Health Canada. Ophthalmology Times. Published May 28, 2024. Accessed October 14, 2024. https://www.ophthalmologytimes.com/view/envista-envy-by-bausch-lomb-approved-by-health-canada

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