New Eye Laser Gets Green Light From FDA Panel
Jan. 20, 2000 (Washington) -- Sunrise Technologies of Freemont, Calif., is proving that if at first you don't succeed, it may, indeed, pay off to try and try again.
After receiving a unanimous rejection from an FDA expert panel of its laser LTK System to treat hyperopia (farsightedness) last July, the maker of ophthalmic devices returned before the same FDA panel recently with an amended application that finally passed. However, the amended application was approved with severely limiting conditions despite the company's attempts to address the panel's earlier concerns.
The application initially was rejected due to a lack of long-term data. Sunrise attempted to address this by offering additional data on patients tracked over two years, as well as carefully crafted explanations as to why patients treated with this laser may have experienced regression of the surgical correction over time. But, despite giving its recommendation for approval by the FDA as a whole, the agency's expert panel still insisted that the proposed indication for the device be further amended to clarify that the treatment's effect was, at best, "temporary."
"If approved, I hope this product does not set a standard for the approval of other products," says Walter Stark, MD, a professor of ophthalmology at John Hopkins University in Baltimore and the FDA panel's lead reviewer.
Nonetheless, the Sunrise LTK system is now well on its way to winning final FDA approval for the correction of mild hyperopia. The Sunrise procedure involves directing laser beams at the cornea. This causes the cornea to change shape, although no corneal tissue is cut or removed, thus correcting the patient's farsightedness. This procedure is somewhat different from the other commonly performed types of laser surgery being done today.
The process used in this type of laser was developed by Bruce Sand, MD. The "Sand Process" is now used in a number of European and Latin American nations for the correction of hyperopia and presbyopia (loss of reading vision due to natural aging), as well as the overcorrection of myopia (nearsightedness) as a result of PRK and LASIK treatments.
PRK, which involves removing a slender layer of the cornea, used to be the most common laser vision correction procedure. However, that process has since been largely replaced by LASIK laser treatments because of LASIK's ability to correct more severe vision problems with shorter recovery time and a decreased risk of infection, haze, and scarring.
The Sunrise LTK System, though, demonstrated even fewer side effects than LASIK in its clinical trials when it came to the treatment of hyperopia.
"The panel in its deliberations really emphasized the negatives," Doyle Stulting, MD, founder of the Vision Correction Group in Atlanta, and a spokesperson for the medical device maker, tells WebMD. He hopes, however, that when the company improves the treatment's stability, Sunrise will be rewarded by the FDA with a more favorable label than the one suggested by the FDA panel.