11.05.18

Clearside Biomedical’s Combination Therapy in RVO Does Not Meet Primary Endpoint in Phase 3 Trial

Source: Clearside Biomedical

Clearside Biomedical announced that the primary endpoint was not achieved in its phase 3 clinical trial (SAPPHIRE) investigating the superiority of XIPERE (formerly 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 8 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,” Daniel White, Chief Executive Officer and President of Clearside, said in a company news release. “In light of these 8-week topline data, we plan to discontinue clinical development of combination therapy for RVO, which includes SAPPHIRE and its companion phase 3  clinical trial, TOPAZ.”

“We believe the opportunity in our primary indication, uveitis, remains very attractive.  Awareness and acceptance of the strong clinical profile of XIPERE as a potential monotherapy in treating uveitic macular edema is growing, and we remain on track to submit our NDA for this indication before the end of this year,” Mr.  White said.

Topline SAPPHIRE Trial Results

SAPPHIRE, a multicenter, multi-country, randomized, masked, controlled phase 3 clinical trial, enrolled 460 patients with treatment naïve RVO. A similar proportion of patients in both arms of the SAPPHIRE trial gained at least 15 ETDRS letters in BCVA at 8 weeks, showing no additional visual outcome benefit for patients in the XIPERE-plus-intravitreal Eylea combination arm compared to patients in the intravitreal Eylea-alone control arm.  The safety profile appeared consistent with previous studies of XIPERE through 8 weeks.  

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