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FDA Clearance of Lensar’s ALLY Adaptive Cataract Treatment System

In the last week, LENSAR, Inc. have announced their FDA clearance for ALLY Adaptive Cataract Treatment System. This is the first FDA-cleared platform to enable cataract surgeons to complete femtosecond-laser assisted cataract surgery procedure in a single environment. ALLY is the first cataract surgery platform to provide ‘Adaptive Intelligence’ to determine cataract density, optimise fragmentation patterns as well as energy settings.

"ALLY is really going to be unique in many, many ways. The system is a fraction of the size of current femtosecond lasers. In fact, it’s just slightly larger than phacoemulsification systems are today in most of the facilities." Nick Curtis, CEO of Lensar. Phacoemulsification is the most commonly performed cataract technique, it is hoped femtosecond-laser assisted cataract surgery will overtake this.

The FDA clearance is for system’s femtosecond laser capabilities. It is in the first stage of its commercial release, first to a controlled targeted audience of surgeons in the third quarter of 2022. In 2023, Lensar intend to make ALLY widely available to cataract surgeons.

Myopia Drug Licencing Agreement Entered

Vyuma and Laboratories Théa have entered a licencing agreement for the registration and commercialisation of childhood myopia drug NVK002 in Canada, Mexico and some South American countries, expanding the previous agreement for Europe and other select countries.

NVK002 is an investigational, preservative-free eye drop to use nightly and intended for slowing the progression of myopia in children ages 3 to 17. It is currently under late-stage clinical evaluation in the Childhood Atropine for Myopia Progression study being carried out in the US and Europe.

“Théa has been an acknowledged pioneer in preservative-free eye care treatments, and by expanding the scope of the agreement signed in 2021, more patients will now have access to this important new therapeutic.” Raul Trillo, MD, MBA and CCO Vyluma.
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