Updated with comments from Carl Zeiss Meditec
The FDA today granted premarket approval to Carl Zeiss Meditec (ETR:AFX) for its VisuMax femtosecond Laser, with indications for small incision lenticule extraction procedures to reduce or eliminate nearsightedness in patients 22 or older.
The newly cleared laser is designed to incise the cornea to create a disc-shaped piece of tissue that’s surgically removed to shape the cornea and correct nearsightedness, according to the FDA.
“This approval expands the surgical treatment options available to patients for correcting nearsightedness,” Dr. Malvina Eydelman, director of the FDA’s Center for Devices & Radiological Health’s ophthalmic and ear, nose & throat division, said in prepared remarks.
The PMA was backed by data from a 328-patient clinical study showing stable vision correction at 6 months, with all but 1 subject reporting visual acuity of 20/40 or better and 88% reporting visual acuity of 20/20 or better.
Complications during surgery included difficulty removing the corneal tissue and loss of suction to keep the laser aligned with the eye. Post-surgery complications included debris at the site of tissue removal, dry eye, moderate to severe glare and moderate to sever halos.
In July, Carl Zeiss Meditec said it tapped James Mazzo as the global president of its ophthalmology business as well as managing the entire company’s U.S. sales and service center.
Mazzo comes from a 3-year run as president and CEO at AcuFocus, where he led the the company to FDA approval for its Kamra inlay. AcuFocus tapped Alan Waterhouse to operate as Prez & COO and Dr. William Link as board chair as Mazzo steps away.
“We are thrilled that this exciting new technology is available for surgeons and patients in the U.S.. I was very impressed with the excellent refractive outcomes in our clinical study, especially in those patients who were most dependent on their spectacles for daily life. Smile will become an important addition to our offerings for patients, and a new and appealing option for those who have concerns about existing choices for surgical vision correction,” study U.S. medical monitor Dr. Jon Dishler of Denver’s Dishler Laser Institute said in a press release.
“I thank the surgeons and clinics who have paved the way for Zeiss to be able to bring this new innovative technology to refractive practices throughout the U.S. For the last 5 years, the popularity of Smile with surgeons and patients outside of the U.S. has continued to grow. With the FDA approval of the VisuMax Smile procedure, U.S. surgeons now have a new premium laser eye surgery option for their practice and can offer the benefits of Smile to their patients. The VisuMax Smile procedure from Zeiss – a major evolution in refractive surgery – has the potential to revitalize and grow the entire U.S. refractive surgery market,” Zeiss U.S. prez & CEO Jim Mazzo said in a prepared statement.
“Zeiss is honored to work with such an esteemed team of clinical investigators to bring this exciting new technology to the U.S.. Launching Smile in the U.S. marks the beginning of a new era in ophthalmology for Zeiss and underscores Zeiss’ commitment to bring innovations to market in support of doctors in advancing their patient care and growing their practice,” prez & CEO Dr. Ludwin Monz said in a prepared release.
