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Company Readies Eye Care Device for Regulatory Submission
A phase 3 clinical study of Medidur for posterior uveitis has met its primary endpoint of prevention of disease recurrence at six months with exceptional statistical significance (P < 0.00000001, intent to treat). Exploratory analyses of Medidur-treated eyes compared with control eyes at six months also showed statistical significance in improving visual acuity (a gain of 15 or more letters on the Early Treatment Diabetic Retinopathy Study [ETDRS] eye chart; P = 0.011); a significant reduction in treatment with systemic therapies (i.e., steroids, immunosuppressants, and biologics; P < 0.01); and significant prevention of loss of vision (a loss of 15 or more letter on the ETDRS eye chart; P < 0.0001).
Medidur is an injectable micro-insert designed to treat posterior uveitis. Injected into the back of the eye, it provides sustained release of 0.18 mg of the corticosteroid flucinolone acetonide at a controlled rate directly to the retina for three years. Medidur consists of the same micro-insert as Iluvien (fluocinolone acetonide intravitreal implant, Alimera Sciences), which has been approved in the U.S. and in 17 countries in the European Union.
Posterior uveitis is a chronic, noninfectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, and is a leading cause of blindness. The disease affects people of all ages, producing swelling and destroying eye tissues. In the U.S., posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness and making it the third leading cause of blindness in this country.
Patients with posterior uveitis are typically treated with systemic steroids, but they often experience serious adverse effects that can limit effective dosing. Patients then progress to steroid-sparing therapy with systemic immunosuppressants or biologics, which can also have severe adverse effects, including an increased risk of cancer. Medidur is designed to provide improved outcomes compared with standard of care, but with a significant reduction in adverse events, according to its developer, pSivida Corp.
pSivida is conducting two phase 3 trials to assess the safety and efficacy of Medidur in the treatment of posterior uveitis. The primary endpoint of these randomized, placebo-controlled, double-blind studies is prevention of recurrence of posterior uveitis at six months, with patients in both trials followed for three years. As noted above, the first phase 3 trial, which enrolled 129 patients, achieved its primary efficacy endpoint with high statistical significance. The second study, which is ongoing, will enroll up to 150 patients in India.
Assuming favorable results from the second phase 3 trial, a new drug application is expected to be submitted to the FDA in the first half of 2017. However, with such positive phase 3 results on the books and a second late-stage study under way, the FDA may agree to an earlier look.
Sources: pSivida Corp; December 28, 2015; and BioSpace; December 29, 2015.