pSivida announced the completion of the originally targeted enrollment of 120 patients in its pivotal phase 3 clinical trial of Medidur for the treatment of posterior uveitis, according to a company news release. pSivida will permit 10 additional patients seeking entry into the trial who met the entry criteria to enroll. pSivida expects to report top line data from the trial in the second half of 2016, and based on the results, to file for regulatory approval in late 2016 or early 2017.
“This is a major advance in the treatment of uveitis, in my opinion, with the delivery of medication into the vitreous cavity without the need for travel to an operating room and with effective provision of corticosteroid for a sustained three years,” C. Stephen Foster, MD, FACS, FACR, president and CEO of Massachusetts Eye Research & Surgical Institute; founder and president of Ocular Immunology and Uveitis Foundation and a clinical professor of ophthalmology at Harvard Medical School, said in the news release. Dr. Foster’s site enrolled the most patients in the study.
Medidur is an injectable micro-insert delivering the steroid flucinolone acetonide (FA) on a sustained basis for 36 months. Medidur uses the same micro-insert (same design, same polymers, same drug, same dose) as Iluvien for diabetic macular edema (DME) developed by pSivida, which has been approved in the US and in 15 EU countries to date. Medidur is inserted via a redesigned applicator that utilizes a needle of the same gauge as that typically used for intraocular injections.
Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the US, posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness making it the third leading cause of blindness in the US.
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 progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer.
“Based on results of a phase 2 study and prior experience with this implant, we believe that Medidur will provide improved outcomes compared to standard of care but with a significant reduction in side effects. Medidur should also lower treatment costs and offer the reduced invasiveness of an injection every 3 years compared with the frequent administration of existing therapies,” Dr. Paul Ashton, President and CEO of pSivida Corp, said in the news release. “We are focused on providing solutions for retinal diseases and believe that this study will demonstrate the safety and effectiveness of Medidur.”
The Medidur phase 3 trial is a double-blind study comparing injections of Medidur to sham injections on a 2-to-1 basis. Patients are enrolled in 16 centers in the US and 17 centers in the EU and India. The primary endpoint of the trial is recurrence of posterior uveitis within 1 year. pSivida plans to seek approval based on the safety and efficacy data from this single phase 3 trial together with short term data from a utilization study of pSivida’s proprietary inserter. The FDA has confirmed that pSivida can reference much of the data, including the clinical safety data, from the phase 3 clinical trials of Iluvien for DME.