Bausch + Lomb Gets Green Light from FDA: New Intraocular Lenses on the Rise

The eye care company Bausch + Lomb has received approval from the U.S. Food and Drug Administration (FDA) for its entire line of enVista Envy intraocular lenses (IOL). This decision paves the way for an upcoming market launch in the United States, which will initially be limited and is expected to expand more comprehensively by 2025. The Canadian company also plans to seek approval in additional countries, while Health Canada already cleared the enVista Envy IOL series in May. In the financial world, rumors are currently circulating about a possible takeover of Bausch + Lomb by private equity firms. According to the Financial Times, a joint bid by investment groups TPG and Blackstone might be considered, based on a corporate value of $11.2 billion, including debt. These developments follow the spin-off of Bausch + Lomb from Bausch Health Companies in 2022, which was first announced in 2020. A class-action lawsuit against Bausch Health accuses the company of making false or misleading statements regarding the spin-off. The lawsuit claims that the separation was not in the interest of Bausch Health shareholders and was instead aimed at averting a securities fraud lawsuit against the company. Bausch Health bears a financial burden with an estimated $21 billion in debt, of which $10 billion is due by 2027. The FDA approval of the enVista Envy IOLs is based on the positive results of a multicenter, randomized, and controlled clinical study. Of 332 participants, 86% reported experiencing little to no issues with glare, halos, or starbursts. A Canadian study showed that 94% of the 110 participants had little to no problems viewing nearby objects, and 93% were completely to moderately satisfied with their vision after surgery. According to GlobalData, the market for intraocular lenses is expected to grow to $5.2 billion by 2030, driven by an increase in cataract surgeries. These products are a significant revenue contributor for Bausch + Lomb, which reported $4.1 billion in revenue last year, with the vision care sector accounting for $2.5 billion.