pSivida announced that top line results from an investigator-sponsored, phase 2 study of pSivida’s Medidur for uveitis will be presented at the 33rd Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) meeting to be held July 10-14 in Vienna, Austria, according to a company news release.
Glenn J. Jaffe, MD, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine in Durham, North Carolina, who is conducting this study, will make the presentation. He also serves as principal investigator in pSivida’s first pivotal phase 3 trial for Medidur for posterior uveitis, which is currently underway.
The American Society of Retina Specialists, a non-profit corporation, provides a scientific forum to promote the advancement of vitreoretinal diseases and surgery to its more than 2,600 members in the United States, Puerto Rico, and 59 countries.
Medidur is an injectable micro-insert designed to treat posterior uveitis that provides sustained release of flucinolone acetonide (a corticosteroid) for 3 years. Medidur comprises the same micro-insert (same design, same polymers, same drug, same dose) as Iluvien for DME. Iluvien has been approved in the United States and 17 EU countries and is sold in the US, the UK, Germany and Portugal.
About Medidur’s Phase 3 Trials
pSivida’s two phase 3 trials for Medidur are double-blind studies comparing injections of Medidur to sham injections on a two-to-one basis. The first trial is fully enrolled with 129 patients in 16 centers in the US and 17 centers outside the US. The primary end point of the first trial is recurrence of posterior uveitis within 1 year. The last scheduled visit for the last patient in this trial is in March 2016, and top-line data is expected in the second quarter of 2016. The second trial will enroll up to 150 patients in approximately 15 centers in India. The primary endpoint of the second trial is recurrence of posterior uveitis within 6 months. Patients in both trials will be followed for 3 years. pSivida’s plans to seek approval for Medidur for posterior uveitis based on 12-month data from the first phase 3 trial, 6-month data from the second phase 3 trial and data from a utilization study of pSivida’s redesigned proprietary inserter together with data referenced from the phase 3 trials of Iluvien for DME. With favorable results, pSivida expects to file a new drug application in the first half of 2017.