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SHORT-TERM INTRAOCULAR PRESSURE REDUCTION INDICATION OKAY FOR ALCON’s IOPIDINE

Executive Summary

The short-term reduction of intraocular pressure (IOP) is a valid indication for Alcon's Iopidine (apraclonidine) solution and other drugs to treat glaucoma patients on maximally-tolerated medical therapy, FDA's Anti-Infective Drugs Ophthalmic Drugs Advisory Subcommittee concluded at its Oct. 26 meeting. "I generally agree with the need for a short-term medication and its clinical relevance," subcommittee member Michael Cobo, MD, Duke University Medical Center, said. While the subcommittee met to consider the indication proposed by Alcon, it did not vote on whether the antihypertensive drug should be approved for such use. FDA Medical Imaging, Surgical and Dental Drug Products Division Acting Director Wiley Chambers, MD told the subcommittee: "I am not asking for approval [or] not approval of Iopidine for this indication. We recognize that there is a need for additional information and that it is in the process of being collected," he said. Instead, Chambers asked the committee to vote whether short-term IOP reduction is "an acceptable indication" that "we should be approving products for." Alcon had been pursuing an Iopidine indication for long-term reduction of IOP in glaucoma patients; however, the company dropped the plan after it discovered in clinical studies that the drug was associated with up to a 20% incidence of allergic-like reactions in this patient group. Alcon VP-Worldwide Clinical Science Thomas McDonald, PhD, explained that the company concluded that allergic reactions may not be such a limitation for short-term treatment of patients in the later stages of glaucoma. Alcon's study for this use is under way. The subcommittee agreed that Iopidine and other drugs might be used in addition to glaucoma patients' existing therapy for IOP to prolong the time prior to surgical procedures. "If you could procrastinate [delay surgery] 24-72 hours....I think it buys the patient a more confident approach to what the conditions are," Cobo said. Several subcommittee members maintained that Iopidine would have to prolong the time to surgery at least by three days for the drug to be of benefit to the patient. The subcommittee also discussed how future studies should be designed to show clinical significance. Douglas Gaasterland, MD, Georgetown University, said: "I believe the studies would have to show [that] when you reduce IOP by an additional 4 mm Hg you are saving vision" from glaucoma. He suggested that a baseline visual field must be established for each patient at least 60 days prior to study entry. One committee member recommended that reduction of IOP could be considered a partial response and delay of surgery a complete response.
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