pSivida Corp. Completes Targeted Enrollment of Phase III Trial of Medidur™ for Posterior Uveitis
"This is a major advance in the treatment of uveitis, in my opinion,
with the delivery of medication into the vitreous cavity without the
need for travel to an operating room and with effective provision of
corticosteroid for a sustained three years," said Dr.
Medidur is an injectable micro-insert delivering the steroid flucinolone acetonide (FA) on a sustained basis for 36 months. Medidur uses the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN® for diabetic macular edema (DME) developed by pSivida, which has been approved in the U.S. and in 15 EU countries to date. Medidur is inserted via a redesigned applicator that utilizes a needle of the same gauge as that typically used for intra-ocular injections.
Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S., posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness making it the third leading cause of blindness in the U.S.
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 progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer.
"Based on results of a Phase II study and prior experience with this
implant, we believe that Medidur will provide improved outcomes compared
to standard of care but with a significant reduction in side effects.
Medidur should also lower treatment costs and offer the reduced
invasiveness of an injection every three years compared with the
frequent administration of existing therapies," said Dr.
The Medidur Phase III trial is a double-blind study comparing injections
of Medidur to sham injections on a two-to-one basis. Patients are
enrolled in 16 centers in the U.S. and 17 centers in the EU and
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. The following are
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: uncertainties
with respect to: ability to achieve profitable operations and access to
capital; fluctuations in operating results; further impairment of
intangible assets; decline in Retisert royalties; successful
commercialization of, and receipt of revenues from, ILUVIEN for DME;
effect of pricing and reimbursement decisions on sales of ILUVIEN for
DME; consequences of flucinolone acetonide side effects; number of
clinical trials necessary to support an NDA for, and regulatory approval
and successful commercialization, of Medidur; development of the
Latanoprost Product and any exercise by Pfizer of its option; ability of
Tethadur to successfully deliver large biologic molecules and
development of products using Tethadur; ability to successfully develop
product candidates, complete clinical trials and receive regulatory
approvals; ability to market and sell products; success of current and
future license agreements; termination of 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; legislative or regulatory changes; volatility of stock
price; possible dilution; absence of dividends; and other factors
described in our filings with the
Follow pSivida on social media:
The President's Blog: http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
News Provided by Acquire Media