Drugs and FDA
Kodiak reports two wet AMD drugs met Phase 3 vision goals
Both experimental drugs were noninferior to Eylea on vision after one year, and Kodiak said 54% of Zenkuda patients went six months between shots.
Kodiak Sciences said its experimental drugs Zenkuda (tarcocimab tedromer) and tabirafusp alfa tedromer met the main vision goal in the phase 3 DAYBREAK trial against Eylea (aflibercept) in people with wet age-related macular degeneration. After one year, both drugs were noninferior to Eylea on best corrected visual acuity, according to Healio and Fierce Biotech.
BioPharma Dive reported average vision test gains of 7.2 letters for Zenkuda and 6.3 letters for tabirafusp, compared with 7.6 letters for Eylea. Kodiak said 54% of enrollees taking Zenkuda went six months between shots, according to BioPharma Dive. Fierce Biotech reported that Kodiak plans to file for FDA approval of Zenkuda in the fourth quarter. The submission is expected to cover wet AMD, diabetic retinopathy and retinal vein occlusion.
