-Fremont, California, September 30, 2002-
NIDEK, Inc. announced today that it has submitted its Hyperopia PMA Clinical Module to the FDA for review and approval for hyperopia, hyperopic astigmatism and mixed astigmatism indication on the NIDEK EC-5000 Excimer Laser System. This marks the final step in gaining commercialization approval by the FDA to market and treat indications of hyperopia with the NIDEK EC-5000 Laser System. This also marks the start of the 180-day approval processing timeline with the FDA.
Hiroshi Okada, Vice President and General Manager of NIDEK, Inc. stated, "We are very happy with the clinical results we have generated and look forward to receiving approval from the FDA on hyperopia within the next few months. We have complied with the FDA regulations in submitting the necessary clinical data they were looking for and are confident that the data we have provided will enable the FDA to approve the EC-5000 for hyperopia indications. With this additional submission for the NIDEK EC-5000, we are continuing our long-standing commitment to providing the refractive surgeon with expanded applications for the laser system. With the anticipated granting of approval from the FDA, doctors will be able to treat patients that are both nearsighted and farsighted in their practices. The laser vision correction market is rapidly growing and NIDEK is continuing to offer its state-of-the-art product to the surgeon community. We have a compelling technology and we will continue to deliver it to the surgeon community to better and further the field of ophthalmology."
NIDEK's EC-5000 Excimer Laser System is currently approved for the reduction and elimination of myopia in the low, moderate and high ranges from -0.75 to -13.00 diopters (D) and moderate myopia with astigmatism ranging in severity from -1.00 to -8.00 D, with a refractive astigmatism from -0.50 to -4.00 D cylinder by manifest refraction, using both LASIK (Laser in-situ Keratomileusis) and PRK (Photorefractive Keratectomy).
"NIDEK is dedicated to providing the highest quality solutions and treatment therapies for quality patient care and surgical outcomes," states Mr. Okada. "The EC-5000 provides expanded treatment options, parameters and an innovative, technologically advanced platform for Refractive Surgery. The NIDEK EC-5000 platform is designed for surgeons' present use as well as future needs, as the field of Refractive Surgery continues to advance and grow. NIDEK is actively working on developing and launching its own custom ablation and wavefront technology platform with the NIDEK EC-5000 Excimer Laser System. Currently this technology is available internationally and will soon be introduced in the U.S. once clinical studies and regulatory processes are done," stated Mr. Okada.