FREMONT, Calif., Oct. 22, 2004 (PRIMEZONE) -- NIDEK, Inc. today announced, 9-month clinical data from its US FDA Hyperopia Clinical Study for the treatment of hyperopia and hyperopic astigmatism. This marks an important milestone in the study protocol, as a total of 248 eyes have been treated, with a total number approved in the study at 300 eyes. Over the last 12 months, NIDEK has worked closely with the FDA on the design, data-collection and evaluation of the clinical study.
"We are extremely excited and very pleased with these results and the 9-month follow-up data that we are getting from our 7 clinical sites for the new hyperopia software for the US EC-5000 platform. The results we have generated to date all exceed and surpass FDA criteria for hyperopia approval and we look forward to collecting all the 9-month data and thereafter working with the FDA to evaluate our submission process. With the expanded study, we look forward to completing the actual treatments in short order and doing the follow-ups necessary for submission and approval with the FDA," commented George Waring, III, MD, Medical Monitor for the NIDEK US Hyperopia Study and Chairman of NIDEK's Medical Advisory Group.
Below is the completed data set for all treated eyes in the US clinical trial. A total of 248 eyes have been treated out of 300 approved eyes for the study protocol.
UCVA - All
Treated Eyes 1-Month 3-Month 6-Month 9-Month
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N 200 122 69 52
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N/n % N/n % N/n % N/n %
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UCVA 20/20
or better 124 62.0 66 54.1 42 60.9 29 55.8
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UCVA 20/25
or better 169 84.5 105 86.1 60 87.0 42 80.8
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UCVA 20/32
or better 189 94.5 118 96.7 65 94.2 51 98.1
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UCVA 20/40
or better 197 98.5 118 96.7 69 100.0 51 98.1
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FDA criteria for hyperopia approval
MRSE within +/- 0.5 D 50%
MRSE within +/- 1.00 D 75%
UCVA 20/40 or better 85%
Loss of 2 or more lines BCVA 5%
Ted Shimomura, Executive Vice President and General Manager of NIDEK, Inc. stated, "These are excellent and outstanding results and we look forward to expediting collection and review over the coming months and thereafter submitting our data to the FDA for approval in short order. NIDEK is truly dedicated to providing the highest quality solutions and treatment therapies for quality patient care and surgical outcomes in refractive surgery. The NIDEK 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. Shimomura.
NIDEK plans to begin custom ablation clinical trials in the United States in the next few months, using its proprietary CATz (Customized Aspheric Treatment Zone) software algorithm and advanced laser hardware. The company has been in detailed discussions with the FDA for the initiation of additional studies to evaluate hardware and software for the NIDEK EC-5000 Excimer Laser System. Additionally, NIDEK and the FDA will review and perform analysis of international clinical experiences with new technologies, including CATz, OATz and OPDCAT software algorithms.
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 -14.00 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 LASIK (Laser in-situ Keratomileusis) or PRK (Photorefractive Keratectomy).
With worldwide operations headquartered in Gamagori, Japan, NIDEK develops, manufactures, and sells laser systems and diagnostic equipment for ophthalmology, optometry, general surgery, gynecology, and cosmetic dermatological surgery. The Company's ophthalmic and optometric products are specifically designed for diagnosing and treating retinal diseases, glaucoma, refractive therapies, retinopathy of prematurity, and pre- and post-operative cataract surgery therapy. Its surgical products are designed to treat patients in the growing applications of cosmetic laser surgery and laser skin resurfacing. NIDEK distributes its products through a network of distribution partners and a direct sales force.
The Nidek Inc. logo is available at http://www.primezone.com/newsroom/prs/?pkgid=1006