Bausch & Lomb is close to launching the first surgically implanted lens of its kind in the U.S. An FDA advisory panel has thrown its weight behind the Trulign Toric device, designed to replace the native lens in patients who have undergone cataract removal surgery, and so emphatic were its votes that approval looks likely.
The device is the first intraocular lens to correct astigmatism, as well as allowing patients to vary their focus – a property called accommodation – according to the FDA. The drive to get the lens approved is further evidence of Bausch & Lomb’s commitment to medical devices and, by extension, a diversified product offering. In a company believed to have been angling for a buyout this would perhaps be risky, although the latest plan seems to be to float a minority stake in Bausch & Lomb (Bausch & Lomb rumoured to be eyeing up buyers, December 13, 2012).
The FDA’s ophthalmic devices panel voted 10-0 with 2 abstentions that Trulign Toric is safe, with the votes on its effectiveness and whether its benefits outweigh its risks both going 10-1 with one abstention. Though not unanimous, the votes were positive enough to point to the lens’s ability to be approved.
That said, the enthusiasm of the panel members is in contrast to that of the FDA’s in-house reviewers, who earlier pinpointed deviations from the protocol of Trulign Toric’s pivotal study.
FDA reviewers said there had been 28 instances where deviations from the study’s protocol had affected data analysis. These included enrollment outside of eligibility criteria, non-compliance with the surgical protocol, and the implantation of incorrect models of the lens. These could cast doubt on the study's ability to demonstrate that the benefit from the lens outweighed the risk, the agency contended.
Its expert panel disagreed, though some members said that post-market studies should be performed to determine the degree of accommodation achievable with the lens.
The sole accommodating intraocular lens platform currently available in the U.S. is Bausch & Lomb’s own Crystalens product line, but Crystalens is not toric, meaning it cannot treat astigmatism. Alternatively, STAAR Surgical (STAA) and Novartis's (NVS) Alcon subsidiary have implantable lenses that correct astigmatism after cataract surgeries, but do not permit the focal variation seen with Trulign Toric.
Around 22 million people in the U.S. aged 40 and older have cataracts, and around 1.5 million cataract surgeries are performed in the U.S. each year. Since around a third of these patients have some degree of astigmatism, Trulign Toric could enable Bausch & Lomb to corner a sizable market.
Bausch & Lomb’s owner, the private equity firm Warburg Pincus, submitted a filing to the U.S. Securities and Exchange Commission in March, seeking to raise $100m in an IPO that would value Bausch & Lomb at about $9-10bn. It is not known whether Warburg is still considering selling the company, although floating a minority stake and allowing the market to set a valuation might be a way of flushing out potential buyers.
A successful launch of Trulign Toric will of course be what the company hopes for – but in drawing attention to its devices it could render Bausch & Lomb a harder sell. Warburg’s IPO filing is likely an admission that it has already had difficulty finding a buyer, and anything that makes that harder will not be welcome.