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STAAR Surgical and Regeneron Pharmaceuticals-in collaboration with Bayer Healthcare-are making strides in Japan.
Monrovia, CA and Terrytown NY-STAAR Surgical and Regeneron Pharmaceuticals-in collaboration with Bayer Healthcare-are making strides in Japan.
STAAR Surgical announced that its Visian implantable collamer lens with CentraFLOW technology-which is driven by the KS-AquaPORT-has been approved by the Japanese Ministry of Health, Labor, and Welfare (MHLW).
With the approval, the range of treatment has been expanded for the lens to include not only the CentraFLOW technology, but also the expanding treatment of myopic down to -3 D, as compared with the current range, which starts at -5 D.
"It is great to see we have . . . approval to use the (lens) technology in Japan," said Kimiya Shimizu, MD, a developer of the product. “Our objective was to improve safety and eliminate the need for the extra procedure of an iridotomy, which can be time consuming and uncomfortable for the patient.
“After 7 years of follow up, the results have been excellent with no IOPincrease, cataract formation, or visual side effects,” continued Dr. Shimizu, also professor and chairman, Department of Ophthalmology at Kitasato University, Tokyo.
"On behalf of STAAR and all the patients who will enjoy premium visual results with the (lens technology), I would like to thank Dr. Shimizu for his pioneering work on this technology," said Barry G. Caldwell, president and chief executive officer of STAAR Surgical.
Additionally, Regeneron announced that Bayer HealthCare’s Japanese subsidiary, Bayer Yakuhin, has submitted an application for marketing authorization for aflibercept (Eylea) injection for the treatment of patients with diabetic macular edema (DME) to the MHLW.
“We are pleased with this regulatory submission and hope that if approved, (aflibercept) will provide a new option for the treatment of DME in Japan,” said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories.
The submission of the treatment for DME in Japan is based on data from the VISTA-DME, VIVID-DME, and VIVID-Japan studies.
The treatment was approved in the United States for the treatment of neovascular (wet) age-related macular degeneration (AMD) in Nov. 2011 and for macular edema following central retinal vein occlusion (CRVO) in Sept. 2012.
The treatment has also been approved in the European Union (EU) and other countries for use in wet AMD and macular edema following CRVO. Regulatory submissions have also been made in the United States and the EU for the treatment of DME.
A regulatory submission has been made in the United States for the treatment of macular edema following branch retinal vein occlusion.
Bayer HealthCare and Regeneron are collaborating on the global development of the drug.
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