JUL 27, 2015
pSivida Corp.
Retina/Vitreous, Uveitis
Medidur, an injectable insert that provides sustained release of flucinolone acetonide for 3 years, may more effectively reduce recurrence and restore vision compared to standard therapy, according to a phase 2 trial.
The ongoing 3-year study is evaluating Medidur in 11 patients with recurrent non-infectious posterior, intermediate or pan-uveitis. Subjects received the insert in the worse eye while fellow eyes were treated with standard of care, including steroid eye drops.
At last follow-up, between 12 and 24 months, no eye treated with Medidur experienced recurrence compared with 2.33 recurrences in the standard care group (P=0.014). Visual acuity also improved significantly in Medidur-treated eyes, gaining an average of 20 letters from baseline, while fellow eyes declined an average of 10 letters.
Elevated IOP was the most common adverse event in study eyes, occurring in 3 eyes, 2 of which required filtering surgery. However, these eyes still gained an average of more than 25 letters from baseline at the last visit.
"The efficacy of Medidur in controlling uveitis and restoring visual acuity was spectacular,” said Dr. Paul Ashton, president and CEO of pSivida Corp. “At the extreme, in addition to completely arresting any recurrence of uveitis, Medidur restored vision to 2 eyes that were legally blind at baseline, improving from 20/400 to 20/25 and from 20/500 to 20/40 at the last follow-up visit."
pSividaexpects to file a new drug application for Medidur in 2017.