Clearside Biomedical seeks FDA nod for macular edema injection

Clearside Biomedical (NSDQ:CLSD) said this week that it submitted a new drug application to the FDA for Xipere – a suprachoroidal injection designed for the treatment of macular edema associated with uveitis.

The Alpharetta, Ga.-based company noted that if Xipere is approved by the FDA, it would be the first therapy for macular edema associated with uveitis.

Clearside’s Xipere injection is a suspension of a corticosteroid – triamcinolone acetonide – that’s formulated for administration via suprachoroidal injection. The company touted that its delivery approach is designed to allow rapid dispersion of the drug to the back of the user’s eye.

“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,” president & CEO Daniel White said in prepared remarks.

“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.,” White added.

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