Bausch + Lomb Receives Health Canada Approval for enVista® Envy™* Full Visual Range Intraocular Lens

Rhea-AI Summary

Bausch + Lomb (NYSE/TSX: BLCO) has received Health Canada approval for its new enVista® Envy™ intraocular lens (IOL), marking the first global regulatory approval of this product. The enVista Envy IOL offers a full visual range with high tolerance to dysphotopsia. Clinical trials in Canada showed excellent long-term outcomes, with 93% of patients reporting minimal visual disturbances and 94% experiencing little to no difficulty viewing close objects while achieving excellent distance vision without glasses. The lens features ActivSync Optic Intelligent Energy Distribution and ClearPath technology, enhancing vision in varying lighting conditions and reducing light scattering. Commercial availability in Canada is set for mid-June, with plans for additional regulatory approvals in the U.S. and Europe.

Positive

• Health Canada approval for enVista Envy IOL, the first global regulatory approval.
• Clinical trials indicate 93% of patients experienced minimal visual disturbances.
• 94% of patients reported little to no difficulty viewing close objects post-surgery.
• Lens offers 4 diopters of continuous visual range, aiding both near and distance vision.
• Utilizes ActivSync Optic Intelligent Energy Distribution for optimized vision in any lighting.
• ClearPath technology helps reduce light scattering, enhancing overall visual quality.
• Low-Cyl toric technology treats presbyopia and low astigmatism with precision.
• Commercial launch in Canada expected by mid-June.
• Plans for regulatory approvals in the U.S. and Europe.

Negative

• Requires additional regulatory approvals in the U.S. and Europe, not currently approved in these markets.
• Potential delays in market expansion depending on regulatory outcomes.
• Pending FDA approval, not yet available for sale or distribution in the U.S. or its territories.

Medical Research Analyst

The approval by Health Canada for the enVista® Envy™ intraocular lens (IOL) by Bausch + Lomb is a noteworthy achievement. This new lens offers a full range of vision with excellent tolerance to dysphotopsia, which includes visual disturbances like glare and halos. The clinical trial results indicate a high level of patient satisfaction, with 93 of patients reporting minimal issues related to dysphotopsia and 94 expressing satisfaction with their ability to see close objects clearly. The lens incorporates innovative technologies such as ActivSync Optic Intelligent Energy Distribution and ClearPath, which optimize vision in various lighting conditions and reduce light scattering. This IOL also addresses presbyopia and low amounts of astigmatism, making it a versatile option for cataract patients. This product's approval could enhance the quality of life for many patients, reducing the need for glasses and contact lenses.

Financial Analyst

The Health Canada approval for Bausch + Lomb’s enVista® Envy™ IOL represents a significant milestone for the company. This approval could potentially drive revenue growth by expanding the company's product portfolio with a premium offering. The company is likely to see increased market share in the ophthalmic sector, especially in Canada, where the product is now approved. The product’s high patient satisfaction rate, coupled with its innovative features, suggests strong market potential. Furthermore, the pending regulatory approvals in the U.S. and Europe could further amplify the revenue streams if granted. Investors should, however, be aware of the potential risks and the competitive landscape in the ophthalmic industry, which is known for rapid innovation and stringent regulatory requirements.

Market Research Analyst

The introduction of the enVista® Envy™ IOL by Bausch + Lomb could have substantial market implications. This lens fills a niche for patients seeking comprehensive vision correction with minimal visual disturbances post-surgery. The technology embedded in the lens, such as ActivSync Optic and ClearPath, positions it as a competitive product in the premium IOL market. Given the aging population and the increasing prevalence of cataracts, the demand for advanced intraocular lenses is expected to grow. Moreover, patients’ increasing preference for high-quality vision correction solutions underscores the market potential for this product. Bausch + Lomb’s strategy to seek approvals in other major markets like the U.S. and Europe could position the company as a leader in the global eye health market.

VAUGHAN, Ontario--(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 Health Canada has approved the enVista^® Envy™* full visual range intraocular lens (IOL). This is the first global regulatory approval of the new lens, which offers a full range of vision with excellent dysphotopsia tolerance on the widely used enVista IOL platform.

“enVista Envy is the next step in the dramatic 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 well-known 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.¹ 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, optimizing 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.

“Today’s cataract patients live vibrant, active lives and have high expectations for vision following surgery,” said Adam Muzychuk, MD, 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 will be commercially available in Canada mid-June. Bausch + Lomb is also in the process of seeking regulatory approvals for the lens in additional markets, including the U.S. and Europe.

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

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.

Forward-looking Statements

This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “will,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

References

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

© 2024 Bausch + Lomb.
VEEVA CODE EVE.0027.USA.24

View source version on businesswire.com: https://www.businesswire.com/news/home/20240528268272/en/

Media Contact:

Caryn Marshall

caryn.marshall@bausch.com

(908) 493-1381



Investor Contact:

George Gadkowski

george.gadkowski@bausch.com

(877) 354-3705 (toll free)

(908) 927-0735

Source: Bausch + Lomb Corporation

FAQ

What recent approval has Bausch + Lomb received for the enVista Envy IOL?

Bausch + Lomb received Health Canada approval for the enVista Envy intraocular lens.

When will the enVista Envy IOL be available in Canada?

The enVista Envy IOL is expected to be commercially available in Canada by mid-June.

What is the stock symbol for Bausch + Lomb?

The stock symbol for Bausch + Lomb is BLCO.

What are the clinical trial results for enVista Envy IOL in Canada?

Clinical trials showed that 93% of patients reported minimal visual disturbances and 94% had little to no difficulty viewing close objects post-surgery.

What features does the enVista Envy IOL have?

The enVista Envy IOL features ActivSync Optic Intelligent Energy Distribution and ClearPath technology, which optimize vision in varying lighting conditions and reduce light scattering.

Is the enVista Envy IOL approved for sale in the United States?

No, the enVista Envy IOL is pending FDA approval and is not yet approved for sale in the United States.