Clearside Biomedical (NSDQ:CLSD) said today that it enrolled the 1st patient in a phase III trial evaluating Zuprata, its suspension formulation of triamcinolone acetonide, in combination with Eylea, intravitreal aflibercept, for the treatment of macular edema associated with retinal vein occlusion.
The trial is slated to enroll 460 patients with retinal vein occulsion to assess the efficacy and safety of the combination therapy. In 1 arm of the study, patients will receive the combination therapy at the beginning of the trial, intravitreal Eylea at week 4 and the combination therapy again at weeks 12 and 24. Patients in the control arm will receive intravitreal Eylea alone every 4 weeks until week 24, the company reported.
Researchers will follow up with the patients for 6 months after 24 weeks of treatment, according to Clearside. The trial’s primary objective is to determine the proportion of patients in each group with the best corrected visual acuity improvement of at 8 weeks following initial treatment.
Investigators will also evaluate secondary efficacy and safety endpoints, Clearside said.
“This patient’s enrollment represents another significant milestone in our Zuprata development program,” CEO & president Daniel White said in prepared remarks. “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.”
In November last year, Clearside enrolled the 1st patient in clinical trial of Zuprata and intravitreal aflibercept, Eylea, for the treatment of diabetic macular edema.
The Alpharetta, Ga.-based company’s Hulk Phase I/II trial is an open-label, multi-center study designed to evaluate the safety and efficacy Zuprata administered in the suprachoroidal space along with intravitreal aflibercept and as an independent therapy in patients with diabetic macular edema. The trial is slated to enroll 20 patients with equal participation in both arms.
