Kodiak Sciences Inc.
announced positive topline results its BEACON Phase 3 study of tarcocimab tedromer (KSI-301; tarcocimab) in patients with macular edema due to retinal vein occlusion.The Phase 3 BEACON study is designed to evaluate the durability, efficacy and safety of tarcocimab tedromer in patients with treatment-naïve macular edema due to retinal vein occlusion.
The Phase 3 study met the primary endpoint of non-inferior change from baseline in visual acuity at week 24 compared to aflibercept and demonstrated robust anatomic responses and a favorable safety profile.
Victor Perlroth, Chief Executive Officer, commented: “Our regulatory strategy is designed to have two successful studies in one indication and then individual studies in additional indications. Looking across our development program for tarcocimab, our paired Phase 3 GLEAM and GLIMMER studies in DME, if successful, are designed to serve as the primary basis for a licensing application and potential regulatory approval of tarcocimab.”
The company is expected to present primary results from the BEACON study at upcoming ophthalmology congresses in September 2022.
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