AMO receives FDA approval for customized monovision LASIK

Santa Ana, CA-Advanced Medical Optics Inc. (AMO) has received FDA approval to market the first wavefront-guided laser vision-correction procedure (Advanced CustomVue Monovision) for patients who have myopia and presbyopia with or without astigmatism. The company expects the treatment to be widely available in the United States later this year and estimates that almost one-third of the approximately 90 million people in the United States with presbyopia could benefit from it.

“With the aging population, the number of patients requiring age-related vision correction will only grow,” said James V. Mazzo, AMO president and chief executive officer. “AMO is making LASIK a viable option for the presbyopic generation.”

“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 the FDA’s Center for Devices and Radiological Health. “Unlike traditional LASIK, [this procedure] may reduce the need for reading glasses in some people over 40.”

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

The FDA based its approval on clinical data from a multicenter clinical trial of 160 patients who were followed up to 2 years. Researchers found that, 6 months after being treated with the procedure, distance and near visual acuity (VA) of at least 20/40 was achieved in all patients, binocular uncorrected distance and near VA of at least 20/40 was achieved in all patients, and more than 96% of patients were able to decrease their use of corrective lenses. After 12 months, more than 98% of patients said they would undergo the procedure again. Also, uncorrected intermediate VA of at least 20/32 was achieved in all patients, and uncorrected intermediate VA of at least 20/20 was achieved in more than 88% of patients.

Side effects, according to the FDA, may include glare associated with bright lights and night driving, halo, light sensitivity, ghost images, double vision, and visual fluctuation. Patients still may require reading glasses or contact lenses to drive at night or read small type.

At the FDA’s request, AMO will conduct a post-approval study following 500 patients for 6 months after surgery to characterize quality-of-vision and quality-of-life issues associated with permanent LASIK monovision correction. The objective of the study is to estimate the proportion of monovision LASIK patients who experience visual disturbances that are severe enough to limit activities or adversely affect their quality of life.