FDA approves customized monovision LASIK

August 1, 2007

Santa Ana, CA-The FDA approval of the first wavefront-guided laser vision-correction procedure (Advanced CustomVue Monovision, Advanced Medical Optics [AMO]/VISX) for patients who have myopia and presbyopia with or without astigmatism will open a new window to the world of age-related vision correction.

Santa Ana, CA-The FDA approval of the first wavefront-guided laser vision-correction procedure (Advanced CustomVue Monovision, Advanced Medical Optics [AMO]/VISX) for patients who have myopia and presbyopia with or without astigmatism will open a new window to the world of age-related vision correction.

The treatment uses AMO’s Advanced CustomVue LASIK technologies, including the Star S4 IR excimer laser and the WaveScan Wavefront and Iris Registration technologies, first to map and then custom-correct myopia in the dominant eye, and partially correct myopia in the other eye.

AMO officials predict that surgeons-“without question”-will be switching from standard monovision ablation to the customized monovision procedure.“This is the first approval within the United States for a laser procedure with presbyopia attached to it,” said Ron Bache, AMO’s global vice president of marketing, corneal refractive surgery group, in an interview with Ophthalmology Times.

“[The procedure] offers a great solution for patients as well as a great tool for [ophthalmologists] to help address patients who are not only myopic but presbyopic,” Bache continued.

About 90 million people in the United States have presbyopia, and about one-third could benefit from customized monovision LASIK, according to the company.

“We think we’ll see a definite increase in the percentage of monovision [procedures] that will occur,” Bache added. He declined to specify the number of customized monovision LASIK procedures that are performed versus traditional LASIK but said most are customized monovision LASIK.

In a multicenter clinical trial of 160 patients for up to 2 years, at 6 months after undergoing the procedure, vision of 20/40 or better was achieved in 100% of patients at both distance and near, and more than 96% of patients decreased their use of corrective lenses.

At 12 months, more than 98% of patients said they would have the procedure again, and 20/20 or better uncorrected intermediate vision was achieved in more than 88% of patients.

“With the aging population, the number of patients requiring age-related vision correction will only grow,” said James V. Mazzo, AMO chairman, president, and chief executive officer, in a statement. “AMO is making LASIK a viable option for the presbyopic generation.”The company said it hopes to make the procedure available to LASIK patients in the United States by the end of 2007.

Because it is a first-in-class technology, the FDA has asked AMO to conduct a post-approval surveillance study of 500 patients for 6 months after surgery to determine quality-of-vision and quality-of-life issues associated with permanent LASIK monovision correction. The study will estimate the percentage of monovision LASIK patients who experience visual disturbances that are severe enough to limit activities or adversely affect a patient’s quality of life.

“The approval … expands permanent vision correction options for nearsighted adults who also have trouble focusing on objects close-up,” said Daniel Schultz, MD, director of FDA’s Center for Devices and Radiological Health, in a statement. “Unlike traditional LASIK, monovision LASIK may reduce the need for reading glasses in some people over 40.”OT