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Once-daily timolol receives ‘approvable’ letter from FDA

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A once-daily liquid formulation of timolol was called “approvable” for the treatment of glaucoma by U.S. regulators.

The Food and Drug Administration issued an “approvable” letter regarding Istalol, the timolol formulation, to Ista Pharmaceuticals, the drug’s U.S. marketer. The FDA cited issues relating to manufacturing methods and controls, but did not request additional information from clinical trials, according to a statement from Ista.

“The issues cited by the FDA in the approvable letter are readily addressable,” said Vincent Anido Jr., PhD, president and chief executive officer of Ista. “We are seeking to qualify an alternate manufacturing site. Based on this, we believe that the product remains on track for approval and launch in early 2004.”

Istalol was developed by Japan’s Senju Pharmaceuticals to be applied topically, once daily. Ista noted in its press release that clinical trials of Istalol show comparable efficacy and safety to twice-daily timolol maleate ophthalmic solution.