Study is the Second of Two Ongoing Phase 3 Trials in Support Of Product Registration in the US
EU Filing Remains on Track for 1Q2017 Filing
"We are very pleased that the second Phase 3 trial of Medidur in posterior segment uveitis has met its patient enrollment goal on target and as expected," said
This first Medidur trial met the primary efficacy endpoint of prevention of recurrence of posterior
segment uveitis at six months in
About Medidur. Medidur is an injectable micro-insert designed to treat posterior segment uveitis and provide sustained release of a corticosteroid, fluocinolone acetonide, for three years. Injected into the back of the eye in an office procedure, it provides sustained release of 0.18 mg of fluocinolone acetonide at a controlled rate directly to the site of chronic inflammation.
About Posterior Segment Uveitis. Non-infectious posterior segment uveitis is a chronic inflammatory disease affecting the posterior segment of the eye, often involving the retina. This condition is a leading cause of blindness in developed countries. It afflicts people of all ages, producing swelling and destroying eye tissues critical for maintaining vision. In the US, posterior segment uveitis is estimated to affect 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 segment 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 can have severe side effects, including an increased risk of cancer. Medidur is designed to deliver small amounts of steroid locally over a sustained period in the eye resulting in potentially reduced systemic exposure compared to systemic medications.
About Medidur Phase 3 Trials. pSivida is conducting two Phase 3 trials to assess the safety and efficacy of Medidur for the treatment of posterior segment uveitis. These are randomized, sham injection-controlled, double-masked trials. The primary endpoint of both trials is recurrence of posterior segment uveitis at six months, with patients in both trials followed for three years. The first Phase 3 Medidur trial, which is fully enrolled with 129 patients in 16 centers in the US and 17 centers outside the US, met its primary efficacy endpoint with high statistical significance. The second trial has met its target enrollment goal of 150 patients and is being conducted in 15 centers in India.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking,
and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to achieve profitable operations and access to capital; fluctuations in our operating results; further impairment of our intangible assets; declines in Retisert royalties; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; potential off-label sales of ILUVIEN for DME; Alimera's ability to continue as a going concern; the effect of pricing and reimbursement decisions on sales of
ILUVIEN for DME; consequences of fluocinolone acetonide side effects; the outcome of a dispute with Alimera regarding commercialization expenses; safety and efficacy results of the second Medidur Phase 3 trial; the number of trials and data required for, and timing of filing and acceptance of, the Medidur NDA and EU marketing approval applications, if at all; maintenance of orphan designation for Medidur; performance by CROs, vendors and investigators; our ability to use data in a US NDA from trials outside the US; our ability to successfully commercialize Medidur, if approved; any exercise by Pfizer of its option with respect to the latanoprost product; our ability to develop Tethadur to successfully deliver large biologic molecules and develop products using it; efficacy and future development of a severe OA implant by us; our ability to successfully develop product candidates,
initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and future license agreements; termination or breach of current license agreements; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; effects of the potential
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