pSivida's Medidur™ Maintains Same High Statistical Significance in Primary Endpoint through 12 Months in First Phase 3 Trial (p Less Than 0.00000001)
"The continued high efficacy and favorable safety results of Medidur in the treatment of posterior uveitis are impressive. Particularly encouraging is the effectiveness of Medidur in controlling recurrence of disease over the longer 12-month period. Medidur-treated eyes were over 5.2 times more likely to be free of recurrence through 12 months than control eyes," said Dr.
Medidur was generally well tolerated through the last follow-up visit (minimum 12 months, maximum 30 months, average 18 months). The incremental risk of elevation of IOP for Medidur-treated eyes compared to control eyes was lower than it was through six months for over 21mmHg (8.3% versus 10.9%) as well as for the more serious elevation over 25mmHg (5.1% versus 11.3%). Elevated IOP was generally well treated with eye drops, and the percentage of eyes requiring incisional surgery to reduce IOP was essentially the same in Medidur-treated and control eyes through the last follow-up (4.6% versus 4.8%).
pSivida has completed initial exploratory analyses and safety evaluations through 12 months of follow up and through the last follow-up visit including the following:
- 22.9% of Medidur-treated eyes and 11.9% of control eyes showed improvement in visual acuity, gaining 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS)
Eye Chartthrough 12 months. The improvement in visual acuity in Medidur-treated eyes seen at six months was maintained at 12 months. This percentage improvement was twice that of control eyes through 12 months, despite the improvement in visual acuity for control eyes.
- Of the 65 patients receiving systemic therapy (steroids, immune suppressants and biologics) at baseline, 52.4% of control patients compared to 18.2% of Medidur treated patients were still being administered systemic treatment at 12 months. These percentages are unchanged from six months.
- Of the study eyes with a natural lens at baseline, 45.2% of Medidur-treated eyes compared to 9.5% of control eyes required cataract surgery through the last follow-up visit. Cataracts are both a side effect of treatment with steroids and a natural consequence of posterior uveitis. 51.7% of Medidur-treated eyes and 50.0% of control eyes had already received cataract surgery before enrolling in the study.
In the first Phase 3 trial, a 129-patient, multi-center, randomized and double-blinded trial evaluating the safety and efficacy of Medidur for the treatment of chronic noninfectious uveitis affecting the posterior of the eye (posterior uveitis), 87 eyes were injected with Medidur, and 42 eyes were randomized to control and received a sham injection. The primary endpoint of the trial was prevention of recurrence of disease at six months, which the study achieved with high statistical significance (p less than 0.00000001; intent to treat analysis). All other efficacy and safety data analyses are exploratory.
About Medidur. Medidur is an injectable micro-insert designed to treat posterior uveitis. 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 enrolling patients.
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, data required for, and timing of filing and acceptance of, Medidur NDA and EU marketing approval applications, if at all; ability to use data in a
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