pSivida (PSDV) Says Medidur Inserter Utilization Study with Smaller-Diameter Needle Met Primary Endpoint
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pSivida Corp. (Nasdaq: PSDV) announced that its utilization study of its new, proprietary 27-gauge inserter for Medidur for posterior uveitis has met its primary endpoint. In the study, 66 percent of injections using the new 27-gauge inserter achieved a satisfactory rating of “Routine,” “Easy” or “Very Easy” while only 46 percent of injections utilizing the earlier, larger 25-gauge inserter used in the first Medidur Phase 3 trial met that standard. The results of this study will form part of pSivida’s planned U.S. New Drug Application and application for EU marketing authorization for Medidur for posterior uveitis.
Paul Ashton, Ph.D., president and CEO of pSivida, said, “This is an excellent result for the new Medidur inserter. The design of the new inserter with its smaller diameter needle was shown in the study to facilitate the ease of administration of Medidur, and we expect it to be more popular with physicians than the earlier, larger needle model. By comparison, ILUVIEN® for diabetic macular edema uses a larger diameter 25-gauge inserter, and Ozurdex® for posterior uveitis, DME and retinal vein occlusion uses an even larger diameter 22-gauge inserter. We plan to use the smaller 27-gauge needle in the inserter in our TKI insert for wet age-related macular degeneration under development.”
The multi-center, randomized, controlled, single masked utilization and safety study assessed the utilization and the safety of the 27-gauge inserter, and the safety of the Medidur insert, from the day of treatment through seven days following administration. In the study, 38 eyes were injected with Medidur, randomized approximately 2:1 to the new 27-gauge inserter or the earlier 25-gauge inserter. The primary endpoint of the study required the proportion of procedures with the new inserter scored as routine or easier to be at least as high as the corresponding proportion of procedures with the 25-gauge inserter. Patients will be followed for 12 months.
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