R-Tech Ueno Receives FDA IND Approval for RU-101 (r-HSA) to Treat Severe Dry Eye
4/26/2013 10:10:16 AM
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TOKYO--(BUSINESS WIRE)--R-Tech Ueno (JASDAQ: 4573): This is to announce that we have submitted IND(Note1) application to US Food and Drug Administration (FDA(Note2)) for clinical trials of recombinant human serum albumin-containing ophthalmic solution (development code: RU-101(Note3)) which is being developed in our company, and we received an approval by FDA. This allows us to initiate Phase I/II clinical trials for RU-101 ophthalmic solution which is being developed for treatment of severe dry eye. We are currently developing RU-101 ophthalmic solution to treat severe dry eye for which no effective treatment has been established, and planning to perform Phase I/II clinical trials in United States for treatment of severe dry eye.
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