Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb has received 510(k) clearance from the US Food and Drug Administration (FDA) for the VICTUS Femtosecond Laser Platform for laser-assisted lens fragmentation during cataract surgery.

The fragmentation procedure, which follows a capsulotomy, uses the femtosecond laser to split the cataractous lens into sections. This is followed by phacoemulsification for cataract removal.  The VICTUS platform offers a number of different lens fragmentation patterns depending on the cataract grade and user preference.  

“Valeant is committed to innovation in healthcare and continues to fund important R&D programmes that will bring benefits to physicians and the patients they serve,” stated J Michael Pearson, chairman and chief executive officer, Valeant Pharmaceuticals International, Inc.  “We will continue to invest in important advancements that will broaden our eye health product offerings and further enhance the strength of the Bausch + Lomb brand.”

“Academic research has shown that cataracts pre-treated with lens fragmentation can require less phacoemulsification energy for removal,” said Y. Ralph Chu, M.D., founder and director of the Chu Vision Institute, Bloomington, MN. “In lower grade cataracts, we have seen up to a 50 per cent reduction in the phaco energy required to remove the lens following lens fragmentation with the laser, compared with standard phaco.”

Bausch + Lomb has been installing VICTUS platforms in leading surgery centers globally since it received CE mark in November 2011 and the FDA clearances in July 2012. It is now one of the only femtosecond lasers in the US with clearance for the creation of a corneal flap in patients undergoing LASIK surgery, anterior capsulotomy during cataract surgery, penetrating arcuate cuts/incisions in the cornea and laser-assisted lens fragmentation during cataract surgery. The VICTUS platform has received additional CE marks for the following, which include: INTRACOR treatment used for flapless intrastromal correction, corneal incisions, penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.  

“The VICTUS femtosecond laser platform delivers major advancements in cataract and refractive surgery, with a combination of precision and simplification for several of the key procedures,” said Dr. Chu. “Laser-assisted capsulotomies and fragmentation may improve the consistency and precision of cataract procedures and will contribute to our ability to provide excellent post-surgical outcomes."

“Bausch + Lomb has made great progress building out a comprehensive and competitive product portfolio for ophthalmic surgeons, and today’s lens fragmentation clearance on the VICTUS platform further strengthens our offerings,” said Calvin Roberts, M.D., chief medical officer, Bausch + Lomb. “For cataract, refractive or retinal surgery, the more you look at Bausch + Lomb, the more you’ll see that we have the platforms, intraocular lenses, instruments, packs, and distribution partnerships that together are helping improve patients’ vision and eye health.”

Femtosecond lasers emit optical pulses of extremely short duration in the domain of femtoseconds, as short as one-quadrillionth of a second. These ultra-short pulses do not transfer heat or shock to the material being cut and can make surgical incisions with extreme precision. The technology was developed in the early 1990s at the University of Michigan Engineering Center. The first commercial platform was introduced in 2002 and the original approval was for flap creation during LASIK surgery.

Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology and branded generics.  

Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight.