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Alcon Withdraws EU Application For Retaane

This article was originally published in The Pink Sheet Daily

Executive Summary

The macular degeneration therapy remains "approvable" in the U.S.

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Alcon's Retaane Is Again "Approvable" For Wet AMD; Firm May Pursue Risk Reduction Indication Instead

FDA approval would require another trial, but "given the market and given what we know about the compound, we are not planning on initiating an additional study," firm tells "The Pink Sheet" DAILY.

Alcon's Retaane Is Again "Approvable" For Wet AMD; Firm May Pursue Risk Reduction Indication Instead

FDA approval would require another trial, but "given the market and given what we know about the compound, we are not planning on initiating an additional study," firm tells "The Pink Sheet" DAILY.

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The firm plans to meet with FDA "to determine the steps necessary to gain final approval." Alcon says it will discuss ongoing studies with anecortave acetate. The ophthalmic agent passed manufacturing inspections, the firm reports.

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