FDA approves enVista Envy IOL from Bausch + Lomb
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Key takeaways:
- Two clinical trials have demonstrated positive results for the full range of vision IOL.
- Bausch + Lomb anticipates wider availability of the lens in the U.S. in 2025.
The FDA approved the enVista Envy full range of vision IOL from Bausch + Lomb, according to a press release.
“Patient expectations of premium IOLs are higher than ever, and they should receive the outcomes that they expect and deserve,” Anthony Wallace, vice president and general manager, U.S. Surgical, Bausch + Lomb, told Healio. “As lifestyles and technology use change, so do our visual needs. Using a variety of digital devices requires excellent near and intermediate vision. enVista Envy creates an opportunity to provide the best of both worlds — a full range of vision and minimal visual disturbances.”
In a multicenter, randomized, controlled clinical trial of 332 participants, the IOL demonstrated “excellent long-term outcomes,” the release said, with 86% of patients reporting little to no issues with dysphotopsia. In addition, a clinical study performed in Canada with 110 participants found that 94% of patients reported little to no difficulty viewing close objects, and 93% were “completely to moderately satisfied” with their vision after surgery.
The enVista Envy IOL is designed to provide effective treatment for patients with a wide range of astigmatism and utilizes the company’s ActivSync Optic intelligent energy distribution to optimize vision in different lighting conditions.
As Healio previously reported, the IOL was approved in Canada in May.
“With more than 6 million implants worldwide, the enVista platform continues to grow,” Wallace said. “It’s made on a material that has demonstrated time and time again optic clarity and a design language that boasts excellent rotational stability and optic recovery after placement. We are working to see where the enVista platform can improve upon or fill gaps in the market for both surgeons and patients.”
Bausch + Lomb anticipates limited commercial availability of the IOL in the U.S. in the coming weeks followed by wider availability in 2025.
Editor’s note: This article was updated on Oct. 14, 2024, to add comments from Anthony Wallace.
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