Presentation of Clearside Biomedical’s Extension Study of PEACHTREE for XIPERE

- January 21st, 2019

Clearside Biomedical (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that data from MAGNOLIA, an extension study of PEACHTREE, its pivotal Phase 3 trial of XIPERE (formerly “suprachoroidal CLS-TA”) in patients with macular edema associated with non-infectious uveitis, was presented by Pauline Merrill, … Continued

Clearside Biomedical (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that data from MAGNOLIA, an extension study of PEACHTREE, its pivotal Phase 3 trial of XIPERE (formerly “suprachoroidal CLS-TA”) in patients with macular edema associated with non-infectious uveitis, was presented by Pauline Merrill, MD during the winter symposium of the American Uveitis Society in Park City, UT. Dr. Merrill is a Partner at Illinois Retina Associates and Section Director of Uveitis in the Department of Ophthalmology at Rush University Medical Center.

As quoted in the press release:

Dr. Merrill’s shared the extension study results in a presentation entitled “Suprachoroidal CLS-TA Maintains Efficacy Outcomes Through 48-weeks in Uveitic Macular Edema subjects: Results of the MAGNOLIA Phase 3 Extension Study.” MAGNOLIA followed 28 of the 96 patients who were in the XIPERE treatment arm of PEACHTREE, across 22 of the clinical sites utilized in PEACHTREE, for six additional months without treatment to better understand XIPERE’s long-term clinical profile.

“In MAGNOLIA, 50% of XIPERE-treated subjects maintained efficacy through 36 additional weeks after their second suprachoroidal injection of XIPERE, without requiring additional treatment,” stated Dr. Merrill. “These data are important to clinicians as we seek new options to reduce the treatment burden on our patients while maintaining the vision gains offered by the treatment, as seen in the PEACHTREE trial.”

“In December, we submitted a new drug application to the FDA for XIPERE to treat macular edema associated with uveitis,” said Clearside’s Chief Medical Officer, Tom Ciulla, MD. “The data from MAGNOLIA expands our understanding of XIPERE and continues to increase our confidence that, if approved, can become an important new treatment option for uveitic macular edema patients. We are actively preparing to introduce XIPERE to the market, should the FDA provide an approval.”

Click here to read the full press release.

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