Combination therapy may reduce treatment burden for RVO

Top-line data from Clearside Biomedical’s TANZANITE trial indicates that concomitant injections of its proprietary triamcinolone acetonide formulation, Zuprata, and aflibercept may be effective in treating macular edema associated with retinal vein occlusion (RVO).

The phase 2 study evaluated 46 treatment-naïve patients randomized to receive intravitreal aflibercept with a suprachoroidal administration of Zuprata or aflibercept alone. At 3 months, 78% (18/23) in the combination group required no additional treatment compared with 30% (7/23) in the control group. BVCA of patients in the combination group increased an average 19 letters compared with 11 letters in the control group. 

In April 2016, Clearside announced that the TANZANITE trial had achieved its primary endpoint, showing that patients receiving both drugs required 60% fewer aflibercept injections in the observation period after initial treatment compared with controls.

The company plans to meet with the FDA in the second half of 2016 to discuss a phase 3 clinical trial.