VAUGHAN, Ontario - Bausch + Lomb Corporation (NYSE/TSX: BLCO), a prominent eye health company, has received approval from the U.S. Food and Drug Administration for its enVista® Envy™ intraocular lens (IOL), designed to provide a full range of vision while minimizing common visual disturbances. The enVista Envy IOL is built on the company's established enVista platform.
Clinical trials in the United States involving 332 subjects demonstrated that the enVista Envy IOL yielded positive long-term results. Reports indicate that 86% of participants experienced minimal issues with dysphotopsia, which includes glare and halos. Similarly, a Canadian study with 110 subjects found that 94% had little to no difficulty with close-up vision, and 93% were satisfied with their vision after surgery.
The enVista Envy IOL incorporates ActivSync Optic technology, which is intended to optimize vision across various lighting conditions. Additionally, the lens offers a toric option to correct astigmatism with increased precision, available in 0.5D steps or smaller throughout the cylinder range.
Alice Epitropoulos, MD, a principal investigator in the Phase 3 U.S. clinical trial, expressed confidence in the enVista platform's ability to deliver superior outcomes for cataract patients. The new lens is expected to further enhance surgical results by offering a broader range of vision and minimal visual disturbances.
Bausch + Lomb plans to make the enVista Envy IOL available in the U.S. on a limited basis soon, with a broader release anticipated in 2025. The company is also seeking regulatory approvals in other markets.
The enVista Envy IOL is indicated for the visual correction of aphakia and less than or equal to 1.0 D preoperative corneal astigmatism following cataract removal. The toric version is also indicated for correcting corneal astigmatism in similar cases. Both lenses aim to provide improved intermediate and near visual acuity while maintaining comparable distance visual acuity to an aspheric monofocal IOL.
The company cautions that some patients may experience visual disturbances, which could be significant enough to request an IOL explant. Surgeons are advised to aim for emmetropia to achieve optimal visual performance and to counsel patients on potential outcomes, including the possibility of spectacle dependence or the need for further surgery.
This announcement is based on a press release statement from Bausch + Lomb.
In other recent news, Bausch & Lomb has been in the spotlight following a robust 20% constant currency revenue growth in the second quarter of 2024, across all segments and regions. This growth has been attributed to strategic product launches such as the enVista NV intraocular lens, Blink NutriTears, and Bausch + Lomb INFUSE contact lenses. As a result, the company has raised its full-year revenue forecast to between $4.7 billion and $4.8 billion, and adjusted its EBITDA guidance to a range of $850 million to $900 million.
Stifel has responded to these developments by raising Bausch & Lomb's price target to $19.00 from the previous $16.00 while maintaining a Hold rating on the stock. The firm's analysis underscored several positive trends observed in Bausch & Lomb's business operations, including growth in the high-margin Consumer business and the Vision Care sector.
On the other hand, Jefferies has maintained its Buy rating on Bausch & Lomb, acknowledging the value present in the company, which is expected to increase after the completion of the Bausch Health (TSX:BHC) Companies (NYSE:BHC) spinoff. The firm also conducted a leveraged buyout analysis to evaluate the potential acquisition price for Bausch & Lomb, in collaboration with Glen Santangelo, who is bullish on Bausch Health Companies.
Finally, Bausch & Lomb is launching a Direct-to-Consumer platform, Opel, and a tool called Glimpse, and is awaiting U.S. approval for their trifocal lens while studying EDOF lenses for a 2026 launch.
InvestingPro Insights
As Bausch + Lomb Corporation (NYSE/TSX: BLCO) celebrates the FDA approval of its innovative enVista® Envy™ intraocular lens, investors may be interested in the company's financial health and market performance. According to InvestingPro data, BLCO has shown strong momentum, with a 25.21% price return over the last month and a 36.73% return over the past six months. This positive trend aligns with the company's recent product approval, which could potentially drive future growth.
InvestingPro Tips highlight that BLCO's net income is expected to grow this year, and analysts predict the company will be profitable. This outlook is particularly relevant given the anticipated limited release of the enVista Envy IOL in the U.S. and broader release in 2025, which could contribute to improved financial performance.
However, it's worth noting that BLCO currently operates with a significant debt burden and has not been profitable over the last twelve months. The company's revenue for the last twelve months as of Q2 2023 stood at $4,495 million, with a revenue growth of 15.14% during the same period. This growth trajectory could be further supported by the new product launch.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights. Currently, there are 10 more InvestingPro Tips available for BLCO, providing a deeper understanding of the company's financial position and market outlook.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.