pSivida Announces Positive Top Line Results From Investigator-Sponsored Phase II Study of Medidur™ for Uveitis
Statistically Significant Reduction in Recurrence of Disease and Statistically Significant Improvement in Visual Acuity
In the three-year, ongoing 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 III clinical trials.) Fellow eyes with uveitis were treated with standard of care, which included steroid eye drops. At the most recent follow-up visit reported, participants have been followed for between 12 and 24 months.
Through the last follow-up visit reported, none of the eyes treated with Medidur had any recurrence of uveitis, while fellow eyes treated with standard of care averaged 2.33 recurrences. The difference between treatment with Medidur and standard of care was statistically significant (p=0.014).
Eyes treated with Medidur experienced a significant improvement in visual acuity, gaining an average of 17 letters from baseline letters at 12 months on the Snellen eye chart (p=0.014 at 12 months). At the last follow-up visit reported, the average gain from baseline in Medidur-treated eyes was over 20 letters, while eyes treated with standard of care declined an average of 10 letters.
The most common adverse event in study eyes was elevated intraocular pressure (IOP). Through the last follow-up visit reported, three study eyes developed elevated IOP and were treated with eye drops, with filtering procedures subsequently performed in two of these eyes. However, those two eyes still gained an average of over 25 letters from baseline at the last observation. The study remains masked as to the dosage so results cannot yet be separated for the low and high doses of Medidur.
pSivida recently announced that at three months in its first Phase III trial, which is testing only the low dose of Medidur, only 4% more study eyes (2/3 of which received Medidur) experienced elevated IOP than the fellow non-study eyes (none of which received Medidur). Initial IOP elevation is an indication of the likelihood of subsequent clinically significant IOP increases. The minimal difference observed in elevated IOP in the assessment suggests highly favorable results for a key safety measure of the trial, the number of eyes that develop clinically significant increases in IOP within 12 months of receiving Medidur relative to control eyes.
"The results in Dr. Jaffe's study are very dramatic. The efficacy of
Medidur in controlling uveitis and restoring visual acuity was
spectacular. At the extreme, in addition to completely arresting any
recurrence of uveitis, Medidur restored vision to two eyes that were
legally blind at baseline, improving from 20:400 to 20:25 and from
20:500 to 20:40 at the last follow-up visit. We look forward to the
unmasking of the data to view the results for the low dose of Medidur we
are studying," said Dr.
About the Phase II Trial. The investigator-sponsored Phase II study is evaluating the tolerability, safety and benefits of high and low dose Medidur in recurrent non-infectious posterior, intermediate or pan-uveitis. Eleven enrolled participants were randomized to receive a masked low or a high dose of Medidur in the worse eye. (Only the low dose is being studied in pSivida's Phase III trials.) Fellow eyes with uveitis are treated with standard of care. Eyes are observed on the day of injection, on days 1, 7, 14, 28, then monthly for up to six months, then every three months for 18 additional months. For purposes of these results, all participants were followed for a minimum of one year, with a mean follow-up duration of 20.5 months. Because the study is ongoing, the dose remained masked, and the results present aggregate data for the low and high dose. Full top-line results of this Phase II study have been submitted for publication.
About Medidur. Medidur is an injectable micro-insert designed to
treat posterior uveitis that provides sustained release of flucinolone
acetonide (a corticosteroid) for three years. Medidur comprises the same
micro-insert (same design, same polymers, same drug, same dose) as
ILUVIEN® for DME. ILUVIEN has been approved in the U.S. and 17 EU
countries and is sold in the U.S., 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 U.S. posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness and 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 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 the Phase III Trials. pSivida's two Phase III trials for
Medidur are double-blind studies comparing injections of Medidur to sham
injections on a two-to-one basis. The first trial is fully enrolled with
129 patients in 16 centers in the U.S. and 17 centers outside the U.S.
The primary end point of the first trial is recurrence of posterior
uveitis within one year. The last scheduled visit for the last patient
in this trial is in
About
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: actual final IOP safety results for Medidur Phase III
trials; 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
fluocinolone acetonide side effects; number and cost of clinical trials
and data necessary to support an NDA for, approval by Indian regulators
of the trial design for, timing of filing the NDA for, and regulatory
approval and successful commercialization of, Medidur; delays in
completion of clinical trials; increases in cost of clinical trials;
changes in, or misunderstandings with respect to,
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