pSivida Submits New Drug Application (NDA) for Durasert™ Three-Year Treatment for Posterior Segment Uveitis to the U.S. FDA
- Category: Small Molecules
- Published on Tuesday, 09 January 2018 10:15
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Proven Durasert Technology Has to Date Received FDA Approval for Three of the Four Sustained Release Drug Products Approved for Back-of-the-Eye Diseases
WATERTOWN, MA, USA I January 08, 2018 I pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Durasert three-year treatment for posterior segment uveitis. The NDA includes data from two Phase 3 studies that each successfully achieved the primary efficacy endpoint at six months with a p value < 0.001. In addition, the safety profile of patients treated with Durasert three-year posterior segment uveitis treatment was consistent with the safety profile of steroid treatments that are currently considered standard of care for this disease.
“We have previously developed and out-licensed three sustained-release treatments for other back-of-the-eye diseases, all of which received FDA approval. This positive track record is an asset as we enter this next phase of development for our company’s first commercial product,” commented Nancy Lurker, President and CEO. “Durasert is our lead product candidate for the treatment for posterior segment uveitis, the third leading cause of blindness. Our goal with Durasert is to provide relief to the thousands of patients suffering from this debilitating disease for which today’s standard of care is frequent injections of steroids or an implant that lasts up to three months with much higher costs. On behalf of everyone at pSivida, I want to thank the retinal specialists and patients for being involved in the studies as their commitment demonstrates the severity of uveitis as a condition with a significant unmet need. We look forward to the FDA’s review process for our submission.”
The FDA will next determine whether pSivida’s NDA is complete and acceptable for review; this procedure is typically completed within 60 days from the original NDA submission date.
About Poster Segment Uveitis
Posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is believed to be a leading cause of blindness in the developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S., posterior uveitis affects between 80,000 – 100,000 people. Today, patients with posterior uveitis are typically treated with systemic steroids, but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer.
About pSivida Corp.
pSivida Corp. (www.psivida.com), headquartered in Watertown, MA, is a leader in the development of sustained release drug products for treating eye diseases. pSivida has developed three of only four FDA-approved sustained-release treatments for back-of-the-eye diseases. The most recent, ILUVIEN®, a micro-insert for diabetic macular edema, licensed to Alimera Sciences, is currently sold directly in the U.S. and three EU countries. Retisert®, an implant for posterior uveitis, is licensed to and sold by Bausch & Lomb. pSivida's lead product candidate, Durasert™ micro-insert for posterior segment uveitis, is being independently developed. Two pivotal Phase 3 studies with Durasert achieved their primary efficacy endpoint of prevention of recurrence of uveitis at six months of follow-up with statistical significance. pSivida's pre-clinical development program is focused on using its core platform technology Durasert to deliver drugs to treat wet age-related macular degeneration, glaucoma, osteoarthritis and other diseases. To learn more about pSivida, please visit www.psivida.com and connect on Twitter, LinkedIn, Facebook and Google+.