ISEE - Iveric bio starts filing with FDA under rolling review for eye drug

• Iveric bio ( NASDAQ: ISEE ) submitted the first part of its new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for rolling review of avacincaptad pegol to treat geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).
• GA is a chronic progressive degeneration of the macula, as part of late-stage AMD and can lead to vision loss.
• The company said it had requested rolling submission of its planned NDA based on data from the trials, GATHER1 and GATHER2, of avacincaptad pegol (ACP, also known as Zimura).
• "As we stated previously, our Special Protocol Assessment (SPA) agreement with the FDA provides a basis for review of our NDA based on 12-month safety and efficacy results from GATHER2, taken together with the results of GATHER1," said Iveric CEO Glenn Sblendorio.

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