Positive results reported for tarcocimab for retinal vein occlusion in phase 3 study
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Tarcocimab tedromer was noninferior to aflibercept in change from baseline in best corrected visual acuity in patients with macular edema due to retinal vein occlusion, according to a press release from Kodiak Sciences.
In the BEACON phase 3 clinical trial, 568 participants with vision loss and macular edema due to retinal vein occlusion (RVO) were randomly assigned to receive tarcocimab tedromer (KSI-301) 5 mg every 8 weeks following two initial monthly loading doses or aflibercept 2 mg every 4 weeks. The primary efficacy endpoint was the change in BCVA from baseline to 24 weeks, which tarcocimab demonstrated in those with branch retinal vein occlusion (P = .0004) and in the overall RVO population (P = .0243).
According to the release, tarcocimab is the first anti-VEGF therapy to achieve noninferiority in BCVA gains while doubling the treatment interval in patients with RVO. The antibody biopolymer conjugate was well tolerated and had a low rate of intraocular inflammation, displaying no new safety signals.
“The positive results of the BEACON study show that tarcocimab can rapidly, robustly and safely improve vision and retinal anatomy in patients with macular edema due to RVO while substantially reducing the number of eye injections,” Jason Ehrlich, MD, PhD, chief medical officer and chief development officer of Kodiak, said in the release.
Full primary study results are expected to be released later this year.
Perspective
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These are encouraging results for this novel platform for the treatment of macular edema secondary to retinal vein occlusion. Achieving greater durability is key, especially in this condition, which is in consequence to very high levels of vascular endothelial growth factor. More detailed results of this study will help us decide if there is true value to tarcocimab tedromer (KSI-301) in routine clinical practice.
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