Zimura receives fast track designation
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The FDA has granted fast track designation to Zimura for the treatment of geographic atrophy secondary to dry age-related macular degeneration, Iveric bio announced in a press release.
Zimura (avacincaptad pegol), a novel complement C5 inhibitor, has shown positive results in a clinical trial and was generally well tolerated after 12 months of administration, the release said.
“With no treatment options available for patients with geographic atrophy secondary to dry age-related macular degeneration, the FDA’s fast track designation recognizes the potential of Zimura to address this unmet medical need,” Glenn P. Sblendorio, CEO and president of Iveric bio, said in the release. “Should the positive results from our initial Zimura pivotal clinical trial be confirmed by our second pivotal clinical trial, we believe this important designation may help expedite the registration of Zimura as a treatment option for our patients.”