Phase III SAPPHIRE clinical trial of Xipere + Eylea fails to meet endpoint in retinal vein occlusion.- Clearside Biomedical.

Clearside Biomedical announced that the primary endpoint was not achieved in its Phase III SAPPHIRE clinical trial investigating the superiority of Xipere (suprachoroidal CLS-TA) used together with the intravitreal anti-VEGF agent Eylea (aflibercept), compared to intravitreal Eylea monotherapy, for the treatment of retinal vein occlusion (RVO). The primary endpoint of this trial was the proportion of patients in the combination treatment arm, compared to the intravitreal Eylea-alone control arm, with improvements in best corrected visual acuity (BCVA) from baseline of at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale at eight weeks after initial treatment.

In the SAPPHIRE trial, approximately 50% of patients in both arms showed at least a 15 letter improvement in vision; unfortunately, there was no additional benefit for patients receiving XIPERE together with intravitreal Eylea. In light of these 8-week topline data, the company plans to discontinue clinical development of combination therapy for RVO, which includes SAPPHIRE and its companion Phase III clinical trial, TOPAZ.