The European Commission has granted eye care company pSivida ($PSDV) an orphan medicinal product designation for its Medidur, which is used to treat chronic noninfectious uveitis.
The designation gives pSivida up to 10 years of market exclusivity in Europe following marketing approval as well as access to the EU’s centralized marketing authorization procedure and other regulatory and financial incentives. The company said it plans to file for European marketing approval for Medidur based on results from its first Phase III trial that met its primary efficacy endpoint with a high statistical significance and achieved positive safety results.
“Receiving designation as an orphan drug is an important milestone in the development of Medidur,” Paul Ashton, pSivida’s president and CEO, said in a statement. “It underscores the need for the development of new therapy to treat this blinding eye disease.
Medidur is an injectable micro-insert designed to treat posterior uveitis and can be administered to the back of the eye during an office procedure.
Uveitis is a noninfectious inflammatory disease often involving the retina and is a leading cause of blindness in developed and developing countries. In the U.S., posterior uveitis affects about 175,000 people, resulting in blindness in about 30,000 cases. Typically, patients with the disease are treated with systemic steroids; however, over time, many of those patients develop serious side effects that can limit the effectiveness of the dosing.
- here’s the pSivida release