Cambridge, Massachusetts, June 21, 2022 — Anida Pharma, a preclinical stage biopharmaceutical company developing first-in-class treatments for the prevention and restoration of vision loss, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to AP-001 for the prevention of retinopathy of prematurity (ROP).
“This adds further recognition to our development of AP-001 as an early intervention eye drop to prevent the sight-threatening condition that develops in many prematurely born infants. In the most premature infants up to 30% develop ROP often in a severe form. No treatment is available to be safely and easily administered to prevent progression of ROP. Short term prevention during the critical period through to full term gestational age would become a game changer in the treatment of ROP”, said Per Gjorstrup MD PhD, Anida President and CEO.
About ROP: Infants at risk are commonly born before gestational week 27 and the earlier born the higher the risk and more severe the condition. A major cause is the formation of pathological blood vessels in the retina associated with inflammation and retina neurodegeneration. ROP is globally increasing. In the US around 30,000 infants each year are born before gestational week 27 with 12,000-15,000 developing some degree of ROP and up to 2,000 with a progressive condition and risk of severe vision loss or blindness. The incidence is similar in the EU, andglobally with up to 70,000/year at imminent risk of vision loss. Long-term complications also include myopia, strabismus, cataract, and glaucoma and may all develop in less severe cases.