Kodiak Sciences Inc. KOD 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.
Price Action : Kodiak shares are trading around 4 percent higher at $10.16 on Monday at the time of publication.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.