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TANZANITE study: No re-treatments required with triamcinolone acetonide formulation after 3 months
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A majority of patients treated with a proprietary form of triamcinolone acetonide in combination with aflibercept required no additional treatments over 3 months compared with patients treated with aflibercept alone, Clearside Biomedical announced in a press release.
The phase 2 TANZANITE clinical trial included 46 treatment-naïve patients with macular edema associated with retinal vein occlusion who were randomized to receive suprachoroidally administered Zuprata (triamcinolone acetonide, Clearside) in combination with intravitreally administered Eylea (aflibercept, Regeneron) or Eylea alone.
Eighteen of 23 patients (78%) in the active arm required no additional treatments over 3 months compared with seven of 23 patients (30%) in the control arm (P = .003).
The primary endpoint of reducing the need for aflibercept re-treatments was announced in April; preliminary results showed that approximately 60% fewer aflibercept injections were required in the active arm than in the control arm (P = .013).
The study also met secondary endpoints of mean change from baseline in best corrected visual acuity and central subfield thickness. At 3 months, the active arm had a mean improvement of 19 letters compared with 11 letters in the control arm.
“The data from the TANZANITE trial support the potential of suprachoroidal delivery to yield visual acuity gains more rapidly with fewer treatments using Zuprata concomitantly with VEGF inhibitors like Eylea in retinal vascular disease, and these clinical data provide support for pursuing further development of Zuprata for the treatment of retinal vascular diseases like RVO and diabetic macular edema,” Daniel H. White, CEO and president of Clearside, said in the release.
Clearside plans to have an end of phase 2 meeting with the FDA in the second half of the year, and if feedback from the FDA is positive, the company intends to initiate a phase 3 clinical trial in the first half of 2017, the release said.