Clearside Biomedical announced the enrollment of the first patient in a phase 3 clinical trial (SAPPHIRE) of Zuprata, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide, used together with Eylea (aflibercept) for the treatment of macular edema associated with retinal vein occlusion (RVO).
SAPPHIRE is a multicenter, randomized, masked, controlled trial to assess the efficacy and safety of suprachoroidally administered Zuprata used together with intravitreally administered Eylea in subjects with RVO. Patients in the combination treatment arm will receive suprachoroidal Zuprata together with intravitreal Eylea at the beginning of the trial, intravitreal Eylea alone at week 4, and suprachoroidal Zuprata together with intravitreal Eylea at weeks 12 and 24. Patients in the control arm will receive intravitreal Eylea alone at the beginning of the trial and follow-up treatments of intravitreal Eylea alone every 4 weeks through week 24. After 24 weeks, patients will be followed for approximately an additional 6 months. The primary objective of this trial will be to determine the proportion of patients in each arm with a best corrected visual acuity improvement of at least 15 letters from baseline at 8 weeks after initial treatment. There will be several secondary efficacy and safety endpoints that will also be evaluated. Clearside anticipates total enrollment of approximately 460 patients in the trial.
“This patient’s enrollment represents another significant milestone in our Zuprata development program,” Daniel H. White, Clearside’s Chief Executive Officer and President, said in a company news release. “Based on the visual acuity improvements and macular edema reductions observed in its previous phase 2 TANZANITE trial, we believe the SAPPHIRE study has the potential to demonstrate that the addition of Zuprata to Eylea treatment may offer an earlier opportunity for improved vision and reduction of macular edema over Eylea treatment alone. We believe that when Zuprata is used together with intravitreal Eylea in RVO patients, it has the potential to provide similar vision results with fewer injections.”