PSivida Corp. announced Wednesday that its posterior uveitis drug Medidur had met its primary efficacy endpoint in a Phase 3 trial, with positive topline results from 129 participants.
Randomized, double-blinded and multi-center, the clinical trial yielded positive safety results as well, on top of achieving its goal of preventing the recurrence of the disease within six months. For that period, just 10.9 percent more patients given Medidur saw an increase in intraocular pressure (IOP) compared to those from the control group. For the trial, 87 eyes received the drug while 42 were randomly chosen to be either part of the control group or be given a sham injection.
"The results of this Phase 3 trial are extraordinary," said Dr. Glenn Jaffe, the trial's principal investigator and chief of the Retinal Ophthalmology Division in pSivida.
With just one injection, Medidur showed that it can control posterior uveitis recurrence, improve visual acuity and even prevent loss of vision. With dramatic results, the clinical trial is opening up the possibility of an important treatment option for patients typically prescribed biologics, systemic steroids or immuno-suppressants and yet still face persisting attacks alongside systemic side effects.
The results of the clinical trial show that Medidur can be a convenient treatment method, as it is easy to administer as a single, in-office micro-insert injection. Because of this, the medication may also improve patient compliance and treatment outcomes for posterior uveitis.
The positive clinical trial results also helped push pSivida's shares up by 34 percent, the company's highest in five years.
About Posterior Uveitis
A chronic, non-infectious inflammatory disease, posterior uveitis affects the posterior segment of the eye, with the retina commonly involved. It affects people of all ages and is a leading cause of blindness in both developing and developed countries as it destroys eye tissues and produces swelling. In the U.S., about 175,000 are diagnosed with posterior uveitis every year, with 30,000 losing their sight annually.
Doctors administer Medidur by injecting it into the back of the eye. Medidur provides a sustained dose of flucinolone acetonide for three years. It uses the same micro-insert as pSivida's Iluvien for diabetic macular edema. A micro-insert is smaller than the exposed lead on a sharpened pencil.
Photo: Ahmed Sinan | Flickr