Clearside’s retinal vein occlusion therapy fails to meet phase 3 endpoint

Xipere, an investigational treatment for retinal vein occlusion, did not achieve its phase 3 clinical trial primary endpoint, Clearside Biomedical announced in a press release.

The multicenter, multi-country, randomized, masked phase 3 SAPPHIRE trial compared Xipere — formerly called suprachoroidal CLS-TA, a proprietary suspension of triamcinolone acetonide — used together with intravitreal Eylea (aflibercept, Regeneron) to Eylea monotherapy.

A similar proportion of patients in both arms of the trial gained at least 15 ETDRS letters in best corrected visual acuity after 8 weeks, with no additional visual outcome benefit for those treated with the combination therapy, the release said.

“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,” Daniel White, CEO and president of Clearside, said in the release.

Xipere, an investigational treatment for retinal vein occlusion, did not achieve its phase 3 clinical trial primary endpoint, Clearside Biomedical announced in a press release.

The multicenter, multi-country, randomized, masked phase 3 SAPPHIRE trial compared Xipere — formerly called suprachoroidal CLS-TA, a proprietary suspension of triamcinolone acetonide — used together with intravitreal Eylea (aflibercept, Regeneron) to Eylea monotherapy.

A similar proportion of patients in both arms of the trial gained at least 15 ETDRS letters in best corrected visual acuity after 8 weeks, with no additional visual outcome benefit for those treated with the combination therapy, the release said.

“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,” Daniel White, CEO and president of Clearside, said in the release.