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istalol |
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istalol Generic Name: timolol maleate ophthalmic solution 0.5% Date of Approval: June 4, 2004 Company: ISTA Pharmaceuticals, Inc. Treatment for: Glaucoma The U.S istalol. Food & Drug Administration (FDA) has approved Istalol, a once- a-dayliquid formulation of timolol, for the treatment of glaucoma. Istalol is a once-daily, topical solution of timolol, a beta-blocking agent forthe treatment of glaucoma istalol. ISTA holds exclusive marketing rights to Istalol inthe United States under an agreement with Senju Pharmaceutical Co., Ltd., whichdeveloped the product in Japan istalol. Senju Pharmaceutical Co., Ltd, is a leading Japaneseophthalmic pharmaceutical company with a pipeline of innovative drugs istalol. In September 2002, Senju submitted the NDA for Istalol to the FDA based ondata from a Phase I clinical study and a multi-center Phase III clinical trialcompleted in the United States istalol. In the clinical trials, once- daily Istalolshowed efficacy and safety comparable to twice-daily timolol maleate ophthalmicsolution, which is the leading beta-blocker to treat glaucoma in the U.S istalol. Advantagesof Istalol include enhanced corneal penetration, as demonstrated in animal studies,and once-daily administration istalol. Other formulations of timolol currently on themarket are commonly prescribed as twice-daily solutions or gel formulations istalol. Gel formulations, in particular, have been shown to cause blurring of patients'vision. Istalol is a branded, patent-protected product istalol. ISTA believes that Istalolmay be eligible to receive certain FDA statutory exclusivity rights and therefore,if granted by FDA, Istalol will not be immediately substitutable by any of thegeneric timolol products currently on the market. |
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Copyright 2005 D-S LTD. |
