Anida Pharma announces US Orphan Drug Designation for AP-001

Cambridge, Massachusetts, March 31, 2020 — Anida Pharma, a preclinical stage biopharmaceutical company developing first-in-class treatments for the prevention and restoration of vision loss, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AP-001 for the prevention of retinopathy of prematurity (ROP).

“This is a significant milestone in our development of AP-001 for the prevention of ROP, a potentially sight-threatening condition in early born preemies. AP-001 is intended as a non-invasive eye drop to be administered to infants at risk of developing the condition and be continued through the critical period to full gestational age. No intervention to prevent development of ROP currently exists and the simple administration of AP-001 as an eye drop could become a game-changer”, said Per Gjorstrup MD PhD, Anida President and CEO, “and supported by strong preclinical data with broad action on pathologies contributing to vision loss.”

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, and globally 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.

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan drug designation provides to Anida certain benefits, including market exclusivity upon regulatory approval, and, exemption of FDA application fees and tax credits for qualified clinical trials.

and in other news…

Anida Pharma announces European Orphan Drug Designation for AP-001

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...