OEM News, Regulatory

Canadian Regulators Approve Bausch + Lomb’s enVista Envy Intraocular Lens

The enVista Envy features ActivSync Optic Intelligent Energy Distribution, which helps optimize vision in every lighting condition.

By: Michael Barbella

Managing Editor

Bausch + Lomb Corporation has gained its first global regulatory approval for the enVista Envy* full visual range intraocular lens (IOL). Health Canada recently okayed the new lens, which offers a full range of vision with excellent dysphotopsia tolerance on the enVista IOL platform.

“enVista Envy is the next step in the transformation of our IOL portfolio,” said Luc Bonnefoy, president, Global Surgical, Bausch + Lomb. “This first premium IOL on the enVista platform follows the U.S. launch of enVista Aspire late last year. The company plans to launch complementary designs to round out the enVista portfolio in the coming months to better address all patient needs.”

A multicenter, randomized, and controlled clinical trial demonstrated excellent long-term outcomes with the enVista Envy IOL in Canada.On average, 93% of patients reported little to no bothersomeness for dysphotopsia (glare, halo, starbursts), touting an impressive tolerance profile overall.1 Additionally, 94% of patients reported little to no difficulty viewing close objects, while delivering excellent distance vision spectacle-free post-surgery with 4 diopters of continuous visual range.1

The enVista Envy features ActivSync Optic Intelligent Energy Distribution, helping to optimize vision in every lighting condition, and ClearPath technology, which helps reduce light scattering. Low-Cyl toric technology allows the enVista Envy toric lens to simultaneously treat presbyopia and low amounts of astigmatism (0.9D IOL Plane – Canada), while offering more precision with 0.5D steps (or less) throughout the cylinder range, according to the company.

“Today’s cataract patients live vibrant, active lives and have high expectations for vision following surgery,” said Adam Muzychuk, M.D., of the University of Calgary. “The attributes of enVista Envy, particularly its full range of vision, with very low rates of visual disturbances, position it as an exciting option for patients hoping to live life with greater freedom from glasses and contact lenses. I look forward to offering it in my practice.”

enVista Envy IOLs is now commercially available in Canada. Bausch + Lomb is also in the process of seeking regulatory approvals for the lens in additional markets, including the United States and Europe.

Bausch + Lomb’s portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products, and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, N.J. 

References
1 Data on File. enVista Envy Canadian Clinical Study.

*The enVista Envy IOL is pending FDA approval and is not approved for sale or distribution in the United States or its territories.

 

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