The FDA clearly saw the truth in the regulatory application for Johnson & Johnson Vision’s new surgical system for improving cataract operations. The aptly named Veritas Vision System has now received both a 510(k) clearance and a CE mark in Europe, putting it on track for a global commercial rollout before the end of the year.
The system comprises several new technologies and features to give surgeons more stability and control throughout the entire phacoemulsification process, the most common form of cataract surgery.
In phacoemulsification, the surgeon inserts an ultrasonic probe into the membrane around the eye’s lens. The vibrating probe breaks up accumulated proteins clouding the lens, then suctions out the remaining pieces of lens material. Once the cataract is removed, a new intraocular lens is implanted in its place.
The Veritas system offers improvements in the ergonomics of the probe for better handling. It also updates the probe’s functioning to reduce the potential for surge, in which the probe gets clogged while aspirating the cataract, then overcompensates with a burst of vacuum-like suction that can cause the anterior chamber of the eye, between the cornea and iris, to collapse.
“While the phacoemulsification technique has been used successfully for decades, ease of use continues to be the unmet need with cataract surgeons," Rajesh Rajpal, J&J Vision’s chief medical officer and global head of clinical and medical affairs, said in a statement.
The company's system has been redesigned for improvements in ergonomics, user experience and fluid flow, Rajpal added.
The Veritas system’s FDA clearance and CE mark come hot on the heels of a busy first quarter for J&J Vision. Earlier this year, the company received FDA approval for two of its intraocular lens implants used in cataract surgery.
And in March, the Acuvue Theravision contact lens, which is infused with the antihistamine ketoifen to fight allergy-related itchiness, netted regulatory approval from the Japanese Ministry of Health, Labour and Welfare. The daily, disposable lens is the first to receive any health authority’s OK for contacts treating both allergies and vision correction.
As a result of these approvals and other new rollouts, Johnson & Johnson reported an uptick in sales across its entire eye-related portfolio in the first quarter of 2021. During that time, the vision business’ worldwide sales clocked in at $1.145 billion, representing an increase of more than 7% from the same period last year. J&J Vision’s surgical business alone saw year-over-year sales growth of nearly 14%.