pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced financial results for its first quarter ended September 30, 2012.
“We are very pleased that the FDA has cleared us to proceed directly to two pivotal Phase III clinical trials of our lead development product, an injectable micro-insert for posterior uveitis,” said Dr. Paul Ashton, President and CEO. “We intend these trials, which we plan to begin next year, to form the basis for a future NDA submission. We are also pleased with the progress and initial results of pre-clinical studies of applications of Tethadur™, our protein/anti-body delivery technology platform.
“With respect to the posterior uveitis micro-insert, the FDA’s decision to allow us to reference much of the ILUVIEN® data for diabetic macular edema (DME), including the clinical safety data, from Alimera Sciences’ already-completed pivotal Phase III clinical trials, has the potential to both simplify any future NDA submission and to shorten development time. We are planning to target enrollment of a total of 300 patients in our two trials, with a primary end point of recurrence of uveitis at 12 months. Because this development product uses the same micro-insert used in ILUVIEN for DME, which delivers a smaller dosage of the same drug as our Retisert® product already approved for posterior uveitis, we expect our trials will show efficacy similar to Retisert but with a side-effect profile in uveitis patients comparable to that seen in DME patients. We are optimistic therefore that our micro-insert will be efficacious for posterior uveitis, with a favorable risk/benefit profile and fewer side effects compared to Retisert,” continued Dr. Ashton.
Tethadur, the Company’s protein/anti-body delivery platform, has the potential to provide sustained release of peptides and proteins in many therapeutic areas and is currently being evaluated in ophthalmology under an agreement with a leading global biopharmaceutical company. In the ophthalmic area, a sustained delivery system like Tethadur for these types of molecules could offer a significant clinical advance because they must currently be injected into the eye every one or two months.