Clearside Biomedical Submits New Drug Application for XIPERE for the Treatment of Macular Edema Associated with Uveitis

- December 20th, 2018

Clearside Biomedical (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced that it has submitted a New Drug Application for XIPERE to the U.S. Food and Drug Administration for the treatment of macular edema associated with uveitis. As quoted in the press release: If … Continued

Clearside Biomedical (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced that it has submitted a New Drug Application for XIPERE to the U.S. Food and Drug Administration for the treatment of macular edema associated with uveitis.

As quoted in the press release:

If approved by the FDA, XIPERE would be the first therapy for macular edema associated with uveitis.

“Based on the data from PEACHTREE, our pivotal Phase 3 clinical trial, we believe that XIPERE has the potential to become a new paradigm in the treatment of uveitic macular edema,” said Daniel White, Chief Executive Officer and President of Clearside. “PEACHTREE was the first clinical trial to demonstrate significant improvement in vision for patients with macular edema associated with non-infectious uveitis, and that improvement was achieved across all anatomical locations of uveitis. In addition, signs of inflammation resolved in more than two-thirds of patients treated with XIPERE across three commonly used measures of inflammation in the eye: vitreous haze; anterior chamber cells and anterior chamber flare. We have an experienced commercial team preparing for the potential launch of XIPERE and we also plan to submit applications for regulatory approval in select markets outside of the U.S.”

Click here to read the full press release.

 

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