Medical Device Network

Bausch + Lomb wins FDA nod for enVista Envy range of intraocular lenses

The approval comes amidst rumours of a potential private equity buyout of the Canadian company, whose parent company has accrued billions in debt.

Eye health firm Bausch + Lomb has received marketing approval for its full range of enVista Envy vision intraocular lenses (IOL) from the US Food and Drug Administration (FDA).

Following the approval, the Canadian company is planning a limited commercial launch in the US in the coming weeks, with a broader launch expected in 2025. The company also reiterated their plan to seek approval for the product in other countries, whilst enVista Envy IOL range received clearance from Health Canada in May.

There have been rumours about the potential private equity buyout of Bausch + Lomb. Financial Times has reported a potential joint bid by private equity groups TPG and Blackstone. Adding that the potential bid to consider the company’s enterprise value of $11.2bn, including debt.

Bausch + Lomb was formed into an independent, publicly traded company as a spinoff from Bausch Health Companies, with the plans being first announced in 2020, with the Bausch + Lomb starting trading in May of 2022. Bausch Health owns a majority (88%) stake in Bausch + Lomb, and has faced significant backlash for the spin-off.

A class action lawsuit against Bausch Health alleges that the company made “false and/or misleading statements and/or failed to disclose” significant facts about the Bausch + Lomb spin-off. Specifically, the spinoff would not result in two strong separate companies and that without Bausch + Lomb, Bausch Health was left overly leveraged.

The total debt incurred by Bauch Heath is estimated to be about $21bn, with $10bn of it coming due before the end of 2027, according to the Financial Times. The lawsuit also goes on to allege that “the spinoff was not intended to benefit Bausch Health shareholders but instead designed to subvert the securities fraud litigation plaintiffs' lawsuit against Bausch Health”.

The FDA approval was based on the positive results from a multicentre, randomised and controlled clinical trial. The study enrolled 332 participants, 86% of these noted little to no issues with glare, halo, or starbursts. In a Canadian trial which enrolled 110 patients, 94% of patients reported little to no difficulty viewing close objects, and 93% were complete to moderately satisfied with their vision post-surgery.

GlobalData estimates the IOL market to grow to $5.2bn by 2030 mostly driven by increased rates of cataract surgeries. IOLs are a high-grossing product for Bausch + Lomb. The reported $4.1bn in revenue last year, with the vision care segment accounting for $2.5bn.