pSivida's Medidur™ Meets Primary Efficacy Endpoint in Phase 3 Trial: High Statistical Significance in Prevention of Recurrence of Posterior Uveitis (p Less Than 0.00000001)
Statistical Significance in Improvement in Visual Acuity and Reduction in Systemic Therapy
Positive Safety Data
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At six-months of follow-up:
- 18.4% of Medidur-treated eyes compared to 78.6% of control eyes had experienced recurrence of posterior uveitis (a statistically significant p less than 0.00000001).
- 23.0% of Medidur-treated eyes compared to 4.9% of control eyes showed improvement in visual acuity gaining 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS)
Eye Chart(a statistically significant p = 0.011).
- 31.0% of control eyes compared to 4.6% of Medidur-treated eyes had lost 15 or more letters from baseline on the ETDRS Eye Chart for at least one observation (a statistically significant p less than 0.0001).
- Of the 65 patients receiving systemic therapy (steroids, immuno-suppressants
and biologics) at baseline, 52.4% of control patients compared to 18.2% of Medidur-treated patients were still being administered systemic treatment (a statistically significant p less than 0.01).
- 27.6% of Medidur-treated eyes compared to 16.7% of control eyes had experienced an increase in intraocular pressure (IOP) above 21 mmHg for at least one observation.
- Of the 64 study eyes with a natural lens at baseline, 9.5% of Medidur-treated eyes compared to 4.8% of control eyes had required cataract surgery.
"The results of this Phase 3 trial are extraordinary. With a single injection, Medidur showed the ability to control the recurrence of posterior uveitis, improve visual acuity and prevent vision loss," said Dr.
The IOP elevation results for Medidur compare favorably to the Phase 3 trial results for ILUVIEN® for diabetic macular edema, which comprises the same micro-insert as Medidur. Other safety results were also positive. Through six months, 2.3% of Medidur-treated eyes and no control eyes required an incisional procedure to reduce IOP. Through the most recent follow-up, 3.4% of Medidur-treated eyes compared to 2.4% of control eyes required an incisional procedure to reduce IOP.
"The results from this Phase 3 trial indicate that Medidur has the opportunity to be an effective, safe and convenient treatment for this blinding eye disease, avoiding the potentially serious side-effects and administration compliance challenges of the cycles of systemic steroids, immuno-suppressants and biologics now used to treat the disease," said Dr.
The primary endpoint of pSivida's Phase 3 trial was prevention of recurrence of disease at six months. All other efficacy and safety data analyses were exploratory.
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 injection-controlled, double-masked trials. The primary endpoint of both trials is prevention of recurrence of posterior uveitis at six months, with patients in both trials followed for three years. The first Phase 3 Medidur trial, which enrolled 129 patients in 16 centers in the
About Medidur. 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 comprises the same micro-insert as ILUVIEN® for DME. ILUVIEN has been approved in the
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.
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; further impairment of our intangible assets; fluctuations in our operating results; 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 flucinolone acetonide side effects; safety and efficacy results of the second Medidur Phase 3 trial, 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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