Iveric Bio leaps on FDA Breakthrough status for eye disease candidate
US biopharma Iveric Bio (Nasdaq: ISEE) received a boost on Friday after its lead treatment candidate won Breakthrough Therapy designation from the US regulator, sending its shares up more than 25% to $21.65.
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Iveric’s Zimura (avacincaptad pegol; ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The AMD market in the seven major markets (7MM: the USA, France, Germany, Italy, Spain, the UK, and Japan) is forecast to grow from $7.3 billion in 2021 to $22.8 billion in 2031. Among the drugs in advanced development, Zimura might compete with Apellis’ intravitreal pegcetacoplan, assuming both make it to market.
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