Medidur uses the same injectable implant and drug as the Iluvien drug-device combo pSivida licensed to Alimera Sciences (NSDQ:ALIM) for treating diabetic macular degeneration. Iluvien won FDA approval in September 2014. Like Iluvien, Medidur is designed to release the corticosteroid flucinolone acetonide over3 years after being implanted in the back of the eye.
Watertown, Mass.-based pSivida said the 129-patient, randomized and double-blinded trial met the primary efficacy endpoint, prevention of recurrence of disease, after 6 months. Patients in the Medidur arm showed an 18.4% recurrence rate, compared with 78.6% of the sham arm. The treatment arm also showed a 27.6% rate of increased intraocular pressure above 21 mmHg for at least 1 observation, 10.9% more than the 16.7% rate for the control group. That difference was reduced to 6.1% after the most recent follow-up visits, some of which were as long as 24 months out, pSivida said.
Through 6 months, 2.3% of Medidur-treated eyes needed an incisional procedure to reduce IOP, compared with no control eyes. 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 company said.
“The results of this Phase III 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,” principal investigator Dr. Glenn Jaffe, of Duke University’s Division of Retinal Ophthalmology, said in prepared remarks. “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 results from this Phase III 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,” added Harvard Medical School’s Dr. Charles Foster, founder & president of the Massachusetts Eye Research & Surgery Institution. “The ability to administer a 3-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.”
Psivida said it plans to conduct a 2nd late-stage study on Medidur, which if successful would lead to a bid for U.S. approval during the 1st half of 2017.
PSDV shares were up 28.4% to $4.75 apiece in mid-afternoon trading today.
It’s been a good month for pSivida and Alimera both. Alimera shares also surged on rumors last week that it’s in the early stages of exploring strategic alternatives, including a potential sale, according to people familiar with the matter.