September 30, 2002
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‘Unique’ timolol formulation submitted to FDA
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IRVINE, Calif. — A formulation of timolol designed to be administered topically once daily for the treatment of glaucoma has been submitted to the Food and Drug Administration, the drug’s U.S. marketer announced.
Ista Pharmaceuticals holds the U.S. marketing rights to Senju Pharmaceutical’s “unique formulation of timolol.” Ista noted clinical trials have shown the new formulation to have comparable efficacy and safety to timolol maleate, commonly applied twice daily for the treatment of glaucoma.
The New Drug Application for Istalol is based on preclinical studies conducted in Japan. Those data have combined with data from a phase 1 trial in the United States and a multi-center phase 3 study recently completed in the United States.