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pSivida's Medidur meets primary efficacy endpoint in Phase 3 trial
WATERTOWN, Mass.—pSivida Corp., a leader in the development of sustained release drug delivery products for treating eye diseases, has nnounced positive topline results from its first Phase 3 clinical trial evaluating the safety and efficacy of Medidur for the treatment of chronic noninfectious uveitis affecting the posterior of the eye (posterior uveitis). The 129 patient, multi-center, randomized and double-blinded trial was highly statistically significant in meeting its primary efficacy endpoint of prevention of recurrence of disease at six months (p less than 0.00000001; intent to treat analysis). Safety results were positive. Only 10.9 percent more Medidur-treated eyes than control eyes experienced an increase in intraocular pressure (IOP) above 21 mmHg through six months, which was reduced to 6.1 percent through the most recent follow-up visits (some as long as 24 months). In the Medidur trial, 87 eyes were treated with Medidur, and 42 eyes were randomized to control and received a sham injection.
At six-months of follow-up:
“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. Glenn Jaffe, Duke University Robert Machemer Professor of Ophthalmology and chief of the Division of Retinal Ophthalmology and principal investigator for this trial. “The high level of statistical significance achieved in this trial is dramatic and, along with the compelling benefit-risk ratio, suggests an important treatment option for patients who are typically treated with repeated systemic steroids, immuno-suppressants or biologics, often facing recurring attacks of the disease as well as systemic side effects.”
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 percent of Medidur-treated eyes and no control eyes required an incisional procedure to reduce IOP. Through the most recent follow-up, 3.4 percent of Medidur-treated eyes compared to 2.4 percent 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. Charles Foster, clinical professor of ophthalmology at Harvard Medical School and Founder and President of the Massachusetts Eye Research and Surgery Institution. “The ability to administer a three-year course of Medidur therapy for posterior uveitis in a single, in-office injection could allow many patients to significantly improve treatment outcomes and vision, reduce side effects and drastically simplify patient compliance as compared to current treatment alternatives.”
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. Topline results and exploratory analyses were all based on intent to treat population.
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 U.S. and 17 centers outside the U.S, achieved its primary efficacy endpoint with high statistical significance (p less than 0.00000001; intent to treat analysis). The second trial, which is still enrolling patients, will enroll up to 150 patients in approximately 15 centers in India. Assuming favorable results from the second Phase 3 trial, an NDA is anticipated in the first half of 2017. pSivida plans to seek FDA approval of Medidur based on six-month data from the two Phase 3 trials and a short-duration utilization study of pSivida’s redesigned proprietary inserter, together with data referenced from the Phase 3 trials of ILUVIEN for DME.
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 U.S. and 17 EU countries and is sold by pSivida’s licensee in the U.S., U.K., Germany and Portugal.
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.
pSivida Corp., headquartered in Watertown, MA, is a leader in the development of sustained-release, drug-delivery products for treating eye diseases. pSivida has developed three of only four FDA-approved sustained-release treatments for back-of-the-eye diseases. The most recent, ILUVIEN, a micro-insert for diabetic macular edema, licensed to Alimera Sciences, is currently sold in the U.S. and three EU countries. Retisert, an implant for posterior uveitis, is licensed to and sold by Bausch & Lomb. pSivida's lead product candidate, Medidur, a micro-insert for posterior uveitis being independently developed, is currently in pivotal Phase 3 clinical trials, with an NDA anticipated in the first half of 2017. pSivida's pre-clinical development program is focused on using its core platform technologies Durasert and Tethadur to deliver drugs and biologics to treat wet and dry age-related macular degeneration, glaucoma, osteoarthritis and other diseases.