pSivida Corp. (PSDV), a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that it has initiated the first of two planned pivotal Phase III trials of its micro-insert for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, a major cause of vision loss in the U.S.
This is the first of two pivotal trials required by the FDA for approval of the micro-insert for the treatment of posterior uveitis. These trials are planned to involve approximately 15 U.S. clinical sites and additional sites world-wide. Both trials will have a primary end-point of recurrence of posterior uveitis at 12 months and are planned to involve approximately 300 patients in total. If the results of the trials are positive, the data will be used by pSivida to submit a New Drug Application to the FDA. The FDA has confirmed that pSivida will be able to reference much of the data, including the clinical safety data, from Alimera’s Phase III clinical trials of ILUVIEN for chronic DME.
Posterior uveitis is an inflammatory disease of one of the layers of the eye. In the U.S., posterior uveitis affects approximately 175,000 people and can be difficult to treat effectively, resulting in an estimated 30,000 cases of blindness in the U.S.