FDA accepts new drug application from Clearside Biomedical's Xipere

vyreitis is a group of inflammatory eye diseases that are one of the leading causes of vision loss, affecting about 350,000 patients in the United States and more than 1 million patients worldwiderecently, Clearside Biomedical(http:// announcedthat theAdministration of theof food and http://drugs (
) of theFDA (http:// had accepted an application forof thenew drug(http:// by Xiperethe NDA application for approval of Xipere vein intracavity injection to treat viticulture-related macular edemaThe FDA has set a target date for the Prescription Drug User Charge (PDUFA) date of October 19, 2019on XipereXipere (Queanbeyan eye drops) is used for intra-envelope injections, apatented(http:// of the corticosteroid quananode, whichis used to treat macular edema associated with vyocarditis through an intracavity injectionClearside's patented technology is designed to transport the drug to the vein upper chamber located between the vein and the outer protective layer of the eye, known as the sclineThe intracavity injection of the vein membrane enables the drug to be quickly and adequately dispersed to the back of the eye, making the drug work longer and minimizing damage to the eye area of the surroundinghealthy(http://, thus potentially providing beneficial and sustainable efficacy and good safetyThe ndA submission
the study is based on data from PeachTREE, a Phase III clinical studyThe study was a randomized, blind, and false-control study that compared Xipere (once every 12 weeks) with a false control in 160 patients with macular edema associated with non-infectious vactitisresults showed that the study reached the primary and all key secondary endpoints and additional endpoints: Xipere treatment showed a statistically significant and clinically significant improvement in vision in patients with non-infectious vofhey-related macular edema compared to false controls, and improved in all anatomical sites of vifalymitisIn addition, in patients with active inflammation at baseline, symptoms were alleviated by three commonly used inflammatory measurement methods (glass turbidity, front-room cells and front-room flares), and more than two-thirds of Xipere treatment patients were relievedThe specific data for the main endpoints of thewere that 47% of patients in the Xipere treatment group received at least 15 letters of improvement in the baseline of optimal corrective vision (BCV) in the 24th week of treatment, compared with 16% in the false control group, with statistically significant differences in the data (p 0.001)