NEW YORK--(BUSINESS WIRE)--Fera is pleased to announce that FDA has granted Orphan Drug Designation for Phospholine Iodide (echothiophate iodide for ophthalmic solution) as a treatment for Stargardt disease.
“Having only just recently acquired Phospholine Iodide from Pfizer in August, we are excited to work toward extending the utility of this medically important product.” says Frank DellaFera, President of Fera.
About Stargardt Disease
Stargardt disease is an eye disease that causes vision loss in children and young adults. It is often called juvenile macular dystrophy with estimated prevalence of 1 in 8,000 to 10,000 people1. In people with Stargardt disease, special light-sensing cells in the macula, called photoreceptors, die off. Central, or detailed, vision becomes blurry or has dark areas. It may also be difficult to see colors well2. Therapy is needed because Stargardt disease is incurable causing debilitating vision loss, typically to the point of legal blindness, and there are currently no FDA approved treatments available.
About Orphan Drug Designation
The FDA Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Among the benefits of orphan drug designation in the U.S. are seven years of market exclusivity following FDA approval, waiver or partial payment of application fees, and tax credits for expenses related to qualified clinical trials conducted after orphan designation is received.
About Fera Pharmaceuticals, LLC
Fera Pharmaceuticals is a privately held company. The company goal is to realize opportunities via acquisitions, in-licensing, developing and marketing abbreviated new drug applications (ANDA), new drug applications (NDA) and 505(b)(2) NDA products. Areas of interest include products that could benefit from lifecycle management with a special focus on niche markets. For more information visit https://www.ferapharma.com/
- MedlinePlus [Internet]. Bethesda (MD): National Library of Medicine (US); [updated 2020 Aug 18]. Stargardt macular degeneration; [updated 2020 Aug 18; reviewed 2010 November 1; cited 2021 Oct 11]; [about 5 p.]. Available from https://medlineplus.gov/genetics/condition/stargardt-macular-degeneration/