Cambridge, Massachusetts, August, 31, 2020 — Anida Pharma, a biopharmaceutical company developing ground-breaking treatments for vision loss, today announced that the US Food and Drug Administration (F.D.A.) has granted rare pediatric disease designation to AP-001 for the prevention of retinopathy of prematurity (ROP). ROP is the most common cause of childhood blindness with very early born infants at risk. Diagnosed at an early stage the further progression should be preventable but no such treatment is currently available to break the catastrophic development to severe vision loss or blindness in those at risk.
“This is a further significant support and incentive to our development of a safe and efficacious treatment for ROP and adds to the previous orphan drug designation granted by FDA”, said Per Gjorstrup MD PhD, Anida Founder and CEO. “In the U.S. the incidence of ROP has increased by 50% over the last 10 years reflecting that infants born at an even earlier gestational age can be saved. However, the earlier born the higher the incidence and greater the severity of ROP further indicating the significant need for early intervention”.
Rare Pediatric Disease designation by the FDA offers a sponsor several advantages including expedited review process, with the potential for fast track review and designation as breakthrough therapy. Importantly, Anida would on approval of AP-001 for ROP be eligible for a priority review voucher for a next NDA submission or the voucher can be traded at significant value.