AUG 09, 2016
pSivida announced that a new, smaller diameter needle for its Medidur device made administration easier.
Medidur is an injectable microinsert for the treatment of chronic, non-infectious posterior uveitis designed to provide sustained release of 0.18 mg fluocinolone acetonide to the retina for 3 years. Recent phase 3 results have indicated very high effectivity for recurrence prevention and good safety results.
In this small cohort, 38 eyes were randomized 2:1 to receive the implant using the new inserter with a 27-gauge needle or the original 25-gauge version (used during the phase 3 trial). Physicians rated 66% of injections with the thinner needle as "Routine," "Easy" or "Very Easy", compared to 46% with the larger needle.
Meeting the endpoint required the satisfaction rate of the new needle to be equal or higher than the rate for the older. These results will be part of pSivida’s U.S. NDA and EU marketing authorization application for Medidur.
The company also plans to use the new needle in their TKI insert for wet AMD that is currently under development.