Eye care company pSivida ($PSDV) said topline results from its Phase III trial of Medidur, designed to treat chronic noninfectious uveitis, exceeded its expectations.
The results of the test, which were released over the weekend at the annual meeting of the American Society of Retinal Specialists in San Francisco, met the primary endpoint of the prevention of recurrence of disease at 6 months, with high statistical significance maintained through 12 months, the company said.
Additional data indicated improvement of visual acuity, elimination of systemic treatments (which can cause serious side effects), and safety results including incidence of cataract and elevated intraocular pressure (which can be a result from the disease itself as well as from steroid treatment).
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.
“Medidur’s performance has continued to exceed our expectations in this phase 3 trial through the latest follow up,” Dr. Paul Ashton, president and CEO of pSivida, said in a statement. “This trial’s results demonstrated that Medidur… can prevent recurrence of disease on a long-term basis while maintaining a favorable safety profile.”
In May, the European Commission granted an orphan medicinal product designation for Medidur.
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