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Executive Summary

Alcon's Betoptic (betaxolol) is viewed by FDA as representing "moderate therapeutic advance over existing therapy" for the treatment of glaucoma. The agency approved the beta blocker on Aug. 30 with a 1-B therapeutic rating. Alcon will be challenging Merck's Timoptic (timolol) in the glaucoma beta blocker class. Timoptic has been on the U.S. market since 1978; the Merck product holds an estimated 75% of the glaucoma treatment market. Both products carry b.i.d. dosing. An Alcon press release announcing the approval claims that Betoptic offers advantages in both safety and price. The Nestle subsidiary said that its betaxolol HCI solution is currently in distribution channels. The price to whlsrs. for the product is $7.40 for a 5 ml bottle and $10.60 for a 10 ml bottle. "The introduction of Betoptic adds the powerful benefit of safety to an extremely effective drug," the Alcon press release asserts. Alcon maintained that Betoptic has "unique properties that set it apart" from Timoptic and allow the drug to "exert little or no effect on lung tissue." Although the Alcon press release does not name the Merck competitor, Alcon states that "a beta blocker drug applied twice a day in eyedrop form. . .has a hidden risk associated with it: when absorbed by the body it can have the effect of slowing heart rate and reducing cardiac output." Alcon further indicated that Timoptic "may reduce the lung's ability to respond to increased demands for oxygen even in such simple situations as climbing stairs." Discussing Betoptic's efficacy, the Alcon release stated that "clinical studies in nearly one thousand patients. . . consistently proved that Betoptic lowers the elevated pressure inside the eye which characterizes glaucoma. Long-term studies indicated that even after three years of continuous treatment, there is no reduction in efficacy."

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