VAUGHAN, Ontario, October 14, 2024--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that the U.S. Food and Drug Administration has approved the enVista? Envy? full range of vision intraocular lens (IOL), which offers a continuous range of vision with excellent 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," said Anthony Wallace, vice president and general manager, U.S. Surgical, Bausch + Lomb.
A multicenter, randomized and controlled clinical trial evaluating 332 subjects demonstrated excellent long-term outcomes with the enVista Envy IOL in the U.S.1 On average, 86% of patients reported little to no bothersomeness for dysphotopsia (glare, halo, starbursts), showing an impressive tolerance profile overall.1 In a Canadian clinical study evaluating 110 subjects, 94% of patients reported little to no difficulty viewing close objects, and 93% were completely to moderately satisfied with their vision post-surgery.2
Envy delivers outstanding performance in all lighting conditions thanks to ActivSync Optic intelligent energy distribution, which optimizes vision in many lighting conditions. Envy also enables surgeons to treat a wider range of astigmatic patients with more accuracy and precision with 0.5D steps (or less) throughout the cylinder range.
"I’ve long trusted the enVista platform to deliver excellent outcomes for my cataract patients," said Alice Epitropoulos, MD, Ophthalmic Surgeons & Consultants of Ohio and principal investigator in the Phase 3 U.S. clinical trial. "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."
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.
enVista Envy toric and non-toric IOL Indications and Important Safety Information
Indications 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.
The 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.
Warnings/Precautions Physicians should weigh the potential risk/benefit ratio before implanting the enVista Envy lens under any of the circumstances or conditions outlined in the Instructions for Use labeling. Some visual disturbances may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or radial lines around point sources of light (starbursts) under nighttime conditions, glare, double vision, haziness and blurred vision. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions such as nighttime driving. 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. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients, therefore, patients implanted with trifocal IOLs should exercise caution when driving at night or in low light or poor visibility conditions. Care should be taken to achieve IOL centration as IOL decentration may result in patients experiencing visual disturbances or suboptimal vision under certain lighting conditions. The surgeon must target emmetropia to achieve optimal visual performance. Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention (e.g., intraocular lens replacement or repositioning). Please provide a copy of the Patient Information Brochure, which can be found at www.bausch.com/IFU. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs earlier in its progression than patients with monofocal IOLs. This may be due to the reduced contrast sensitivity observed with multifocal IOLs.
Additional Precautions for Toric IOLs: The enVista Envy Toric IOL has not been evaluated in a clinical study. In general, astigmatism that is corrected with a higher cylinder power IOL can result in clinically significant residual astigmatism. The effect of residual astigmatism at distance, intermediate, and near was evaluated in a clinical study of patients who had been implanted with non-toric enVista Envy IOLs and were induced with cylinder power to simulate various levels of residual astigmatism. If a secondary surgical intervention is necessary to reposition the IOL, explantation should be considered as some patients may have recurrent or persistent issues related to rotational instability and misalignment.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
ATTENTION: See the Directions for Use for a complete listing of indications and important safety information.
About Bausch + Lomb Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive 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, New Jersey. For more information, visit www.bausch.com and connect with us on X, LinkedIn, Facebook and Instagram.
References
Data on file. enVista Envy U.S. Clinical Study.
Data on file. enVista Envy Canadian Clinical Study.
