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Clearside’s triamcinolone acetonide formulation achieves primary endpoint in phase 2 clinical trial
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Clearside Biomedical reported in a press release that its triamcinolone acetonide formulation candidate Zuprata achieved its primary endpoint of reducing the need for Eylea retreatments in patients with macular edema associated with retinal vein occlusion.
In the phase 2 masked, controlled Tanzanite trial, participants were randomized to receive either intravitreal Eylea (aflibercept, Regeneron) alone or both intravitreal Eylea and suprachoroidal triamcinolone acetonide at the same time, according to the release.
Preliminary results revealed that patients who received both Eylea and Zuprata qualified for 60% fewer intravitreal Eylea retreatments than those in the control group during the 3-month observation period after initial injection (P = .013).
Furthermore, best corrected visual acuity was improved more in the Zuprata group than in the control group: 19 letter improvement vs. 11 letter improvement, according to the release.
“Based on these results, Clearside intends to follow a 505(b)(2) NDA regulatory approval pathway and expedite the preparations for a Zuprata phase 3 registration program for the treatment of macular edema associated with RVO,” Clearside president and CEO Daniel H. White said in the release.