Clearside Xipere extension study shows durability in macular degeneration

Clearside Biomedical announced that data from MAGNOLIA, an extension study of PEACHTREE, its pivotal Phase 3 trial of Xipere in patients with macular edema associated with non-infectious uveitis, was presented during the winter symposium of the American Uveitis Society in Park City, UT. 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,” Pauline Merrill, Partner at Illinois Retina Associates and Section Director of Uveitis in the Department of Ophthalmology at Rush University Medical Center, said. “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. “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.” The most common adverse events seen in the MAGNOLIA trial included cataracts and increases in intraocular pressure and were consistent with previous trials of XIPERE. No serious adverse events were reported.
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