NIDEK Hyperopia Clinical Study Update & Future FDA Studies
-Fremont, CA USA, May 4th, 2004-
NIDEK, Inc. announced today that it has completed and submitted 3-month clinical data for its new hyperopia study to the FDA. This marks an important milestone in the study process, as additional treatment eyes will be initiated in the study protocol effective immediately. NIDEK also received approval from the FDA to expand the clinical study to 300 eyes under the current treatment protocol. The expansion will include 150 eyes each for spherical hyperopia and hyperopic astigmatism. NIDEK has worked closely with the FDA on the design, initiation and evaluation of the clinical study.
“We are excited and very pleased with these initial results of the new hyperopia software for the US EC-5000 platform. The study expansion approval to 300 eyes marks an important milestone for the hyperopia trial. We look forward to evaluating the 6-month follow-up data in short order, as this initial data sample is an excellent step in getting the new hyperopia approved for the US Market”, commented George Waring, III, MD, Medical Monitor for the NIDEK US Hyperopia Study and Chairman of NIDEK’s Medical Advisory Group.
Below are the 3-Month data generated with 46 eyes treated with the new hyperopia algorithm. A total of 70 eyes have been completed as part of this clinical trial.
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3-Month Results
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3-Month
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Total 46 Eyes
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n/N
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%
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MRSE within +/- 0.5 D
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35
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76.1
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MRSE within +/- 1.00 D
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42
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91.3
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UCVA 20/40 or better
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45
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97.8
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Loss of 2 or more lines BCVA
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0
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0.0
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FDA criteria for hyperopia approval
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MRSE within +/- 0.5 D
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50%
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MRSE within +/- 1.00 D
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75%
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UCVA 20/40 or better
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85%
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Loss of 2 or more lines BCVA
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5%
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Ted Shimomura, Executive Vice President and General Manager of NIDEK, Inc. stated, "We are very happy with the initial clinical trial results and we look forward to expediting collection and review over the coming months. NIDEK is dedicated to providing the highest quality solutions and treatment therapies for quality patient care and surgical outcomes”. "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. Shimomura.
NIDEK has begun 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 experiences with new technologies. 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).
For further information, contact:
Mr. Mitsutoshi Amano
Title: Manager, Corporate Planning
Phone: +81-533-67-6753
Fax: +81-533-67-6610
Email: mitsutoshi_amano@nidek.co.jp
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