pSivida (PSDV) Says Results from First Phase 3 Trial of Medidur Presented at ASRS
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pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release drug delivery products primarily for eye diseases, announced that Dr. Glenn J. Jaffe, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine in Durham, NC and the principal investigator on the first of pSivida’s two Phase 3 trials of Medidur for recurrent non-infectious uveitis affecting the posterior segment of the eye, presented the topline results from the trial through its six-month primary endpoint and through 12 months of follow-up. Dr. Jaffe’s presentation, “A Randomized, Masked, Controlled, Safety and Efficacy Study of an Injectable Fluocinolone Acetonide (FA) Intravitreal Insert in Non-Infectious Uveitis” took place at the Inflammatory and Infectious Disease session of the American Society of Retinal Specialists Annual Meeting, on Sunday, August 14, in San Francisco.
This was the first scientific presentation of the topline results from this Phase 3 trial, which met its primary end point, prevention of recurrence of disease at six months, with high statistical significance (p less than 0.00000001, intent to treat analysis) maintained through 12 months. In addition to data on prevention of recurrence of disease, Dr. Jaffe presented data on additional exploratory analyses on improvement of visual acuity, elimination of systemic treatments (which can cause serious side effects), and safety results including incidence of cataract and elevated intraocular pressure (which can be a result from the disease itself as well as from steroid treatment).
“Medidur’s performance has continued to exceed our expectations in this phase 3 trial through the latest follow up,” said Dr. Paul Ashton, president and chief executive officer of pSivida Corp. “This trial’s results demonstrated that Medidur – administered by injection in an office setting – can prevent recurrence of disease on a long-term basis while maintaining a favorable safety profile. Medidur has the potential to be a promising new treatment for patients with posterior uveitis who have limited options to control their disease effectively.”
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