Investigator-Sponsored Phase 2 Study Results Show pSivida's Medidur® Fully Controlled Uveitis for Two Years with No Recurrence of Disease While Visual Acuity Continued to Improve
"Medidur's performance in these two-year results continued to exceed our expectations," said Dr.
Other safety results were also positive. The most common adverse event was elevated intraocular pressure (IOP), which occurred in 18% of Medidur-treated eyes after implantation and was managed by standard means. Two eyes were treated with filtration procedures during the two years.
A paper entitled "Injectable Fluocinolone Acetonide Long-Acting Implant for
Noninfectious Intermediate Uveitis, Posterior Uveitis, and Panuveitis" will be published in the journal Ophthalmology and is online in advance of print publication at http://www.aaojournal.org/article/S0161-6420(16)30330-X/abstract.
In this three-year study, 11 participants with recurrent non-infectious intermediate, posterior or pan uveitis were randomized to receive a masked low or a high dose of Medidur. (pSivida is studying only the low dose of Medidur in its Phase 3 clinical trials.) Fellow eyes with uveitis were treated with standard of care, which included steroid eye drops. Participants were assessed throughout the 24-month follow-up period of the study.
About Medidur. Medidur is an injectable micro-insert designed to treat posterior uveitis and provides sustained release of fluocinolone acetonide (a corticosteroid) for three years. Injected into the back of the eye in an office procedure, it provides sustained release of 0.18 mg of the corticosteroid fluocinolone acetonide at a controlled rate directly to the retina for three years.
About Posterior Uveitis. Posterior uveitis is a chronic, non-infectious inflammatory disease
affecting the posterior segment of the eye, often involving the retina, which is a leading cause of blindness in the developed and developing countries. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the
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. Medidur is designed to provide improved outcomes compared to standard of care but with a significant reduction in side effects.
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 uveitis. These are randomized, sham-controlled, double-masked trials. The primary endpoint of both trials is recurrence of posterior 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 U.S. and 17 centers outside the U.S., met its primary efficacy endpoint with high statistical significance. The second trial, which will include up to 150 patients in approximately 15 centers in India, is currently being enrolled.
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: Designation of Medidur as an orphan medicinal product; 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; the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of fluocinolone acetonide side effects; safety and efficacy results of the second Medidur Phase 3 trial, 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; ability to use data in a
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