A week after the company revealed sales of its Proclear contact lens have advanced strongly this year, Biocompatibles has announced the lens will undergo clinical trials in Japan.
The company said this week that a clinical and regulatory programme designed to secure Ministry of Health, Labour and Welfare approval in Japan for the lens which uses phosphorylcholine technology, a chemical copy of part of the outer layer of human cell membrane.
The regulatory programme is being managed by BiocompatiblesÕ Japanese marketing partner, Rainbow Optical Laboratories. Candidates for the first clinical trial sites have been enrolled at Juntendo University School of Medicine and Kyoto Prefectual University of Medicine.
ÔJapan is an important new market for our eye care products,Õ said Biocompatibles chief executive Crispin Simon, Ôand we are encouraged by the progress that Rainbow has already made with the regulatory programme.Õ
Submission for regulatory approval is expected next year.
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