Medical Device Daily
LASIK has come along way since its initial roll-out in 1990 as a relatively crude "flap and zap" procedure.
Though now a mature technology, new advancements in LASIK keep coming.
And AMO/VISX (Santa Clara, California) is giving LASIK patients still another, much more sophisticated, way of looking at things with its CustomVue Monovision LASIK procedure.
The company reported receiving FDA approval for marketing the first-ever LASIK device for treating one eye to see far away objects and the other eye for close-up vision.
"This is the first company to receive FDA approval for a monovision LASIK procedure," Kris Mejia, a spokeswoman for the FDA told Medical Device Daily.
The CustomVue procedure uses the previously approved Wavefront-guided treatments – an eye mapping system that guides the laser — for myopia ad astigmatism.
The FDA said in a statement that the procedure is designed "to correct nearsightedness in the patient's dominant eye and only part of the nearsightedness in the non-dominant eye. This allows the patient to use the fully corrected eye for distance vision and the under-corrected eye for seeing close up. After a period of time, the brain adjusts to the difference in perception between the two eyes."
It advised that people considering the procedure should first wear monovision contact lenses for at least a week to determine if they can tolerate having one eye under-corrected. "Following monovision surgery, the two eyes may not work together as well as they did before in some patients, especially in dim light or when performing tasks requiring very sharp vision or fine depth perception. Patients may need to wear glasses or contact lenses for some activities such as night driving or reading small type."
The FDA based its approval on the review of a clinical study of safety and effectiveness outcomes.
"We're looking to release this procedure to the public later this year," Ron Bache global VP of AMO/VISX, told Medical Device Daily. "It will be sometime definitely before the end of the year."
"The difference [between LASIK and Mono LASIK surgery] lies in the degree of correction in both eyes," Mejia, told MDD.
Referring to the need for adjustment, post-procedure, Mejia said, "Most of the literature [regarding the procedure] offers about six weeks for the brain to make the adjustment. But this differs in each individual."
The FDA also noted some potential side effects.
Following the surgery the two eyes might not work as well with each other as they did before in some patients, especially in dim light or when performing tasks requiring very sharp vision or fine depth perception. Patients could still need to wear glasses or contact lenses for some activities such as night driving or reading small type.
Other side effects may include glare from bright lights, rings around lights (halos), light sensitivity, night driving glare, ghost images, double vision and visual fluctuation.
"As with any laser vision correction there are risk and benefits to be considered," Mejia said.
AMO/VISX is slated to conduct a post-approval study following 500 patients for six months after surgery to characterize quality of vision and quality of life issues associated with permanent LASIK monovision correction. The objective of the study will be to estimate the proportion of monovision LASIK patients who experience visual disturbances severe enough to limit activities or adversely affect quality of life.
"Oftentimes the FDA will see a post-approval study done by a company offering a new product," Mejia said.
She declined to comment on any other companies that have asked for FDA approval for the procedure.
AMO/VISX, the company involved in the procedure, has been garnering attention lately.
Earlier this week AMO surprised many with its llth hour $4.3 billion offer for larger eye care rival Bausch & Lomb (Rochester, New York)(MDD, July 9, 2007).
And last week AMO told analysts that it forecast a loss as high as $1.15 a share on sales of $1.05 billion to $1.07 billion this year because of the recall, a marked decrease from the previous forecast of earnings up to $1.55 a share on sales as high as $1.18 billion.
While the $75-a-share offer trumps Warburg Pincus' $3.67 billion offer which values the shares at $65, there are key differences in the two offerings that make comparison difficult.
The offer was surprising, given that the company just had a costly voluntary global recall of its complete moisture plus multi-purpose solution the company said it would shift focus to "rub" formulations of lens cleaners and hydrogen peroxide products, (MDD, June 6, 2006).
The company's problems with its contact lens solution have not resulted in a lack of interest in the new LASIK procedure, with the company saying that interest in the procedure has been overwhelming.
"The emails that we've been receiving are very positive, people are thanking us for continuing to push forward with this procedure," Bache said. "We believe this procedure fills a niche that once went unfilled."