pSivida Corp., a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, has started 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 US.
"We are extremely pleased that our first three US clinical sites have begun recruiting patients for this trial," said Paul Ashton, Ph.D., president and CEO of pSivida. "We are very optimistic that our micro-insert will be efficacious for the treatment of posterior uveitis with a more favorable risk/benefit profile, fewer side effects and greater ease of administration than Retisert, our current FDA-approved product for the treatment of the same disease."
The micro-insert, a tiny tube about the size of an eyelash that releases the steroid fluocinolone acetonide on a sustained basis for up to 36 months, is the same micro-insert licensed by pSivida to Alimera Sciences, Inc. Alimera has received marketing approval for the micro-insert in six EU countries for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and has commenced the direct commercialization of the micro-insert in Germany and the United Kingdom under the name ILUVIEN. The FDA has set a new Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 for ILUVIEN. pSivida did not license the micro-insert to Alimera for the treatment of uveitis and is developing this product without a partner.
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 US 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 US, 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 US.
"In our uveitis trials, we expect to maintain similar efficacy to that seen in the Retisert phase III trials but with a similar side-effect profile to that seen in DME patients in the phase III studies for ILUVIEN," said Dr Ashton. "The Retisert implant is FDA approved for posterior uveitis and the micro-insert delivers the same drug as Retisert, so we expect the micro-insert to be efficacious. Based on the phase III studies for ILUVIEN, we also expect the micro-insert to have a lower incidence of serious increased in intraocular pressure (IOP) than Retisert. The ILUVIEN studies showed an incidence of serious elevated IOP that was three times lower than that seen in the Retisert phase III trials, and the incidence of patients requiring surgery for increased IOP in the ILUVIEN studies was seven times lower. The micro-insert releases drug at a slower rate and is also easier to administer than Retisert, because the micro-insert is injected in an office visit while Retisert must be implanted in a surgical procedure."
pSivida Corp., develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years.