• Zenkuda and KSI-501 were noninferior to aflibercept in improving best corrected visual acuity.
• Kodiak Sciences will submit a biologics license application for Zenkuda in the fourth quarter.

Editor’s note: This is a developing news story. Please check back soon for updates.

Two investigational agents from Kodiak Sciences helped improve vision in patients with wet age-related macular degeneration, according to a press release.

In the phase 3 DAYBREAK study, researchers assessed Zenkuda (tarcocimab tedromer) and KSI-501 (tabirafusp alfa tedromer) vs. Eylea (aflibercept, Regeneron) in patients wet AMD. Zenkuda is an anti-VEGF that uses Kodiak’s antibody biopolymer conjugate (ABC) platform and is designed to maintain more durable drug levels. KSI-501 is an anti-IL-6, VEGF-trap bispecific also built on the ABC platform, according to the release.

At 1 year, both therapies met the primary endpoint of noninferiority in best corrected visual acuity compared with aflibercept.

Zenkuda met the primary endpoint (P = .0007) demonstrated by vision gains along with fast and sustained retinal drying. More than half of patients were on a 6-month dosing interval, according to the release.

KSI-501 achieved the primary vision endpoint (P = .0036) and secondary anatomical endpoint (P < .0001), and Kodiak is planning a post hoc analysis to find out which patients may benefit from IL-6 inhibition the most, according to the release.

The company plans to submit a biologics license application later this year for Zenkuda for three indications: wet AMD (phase 3 DAYBREAK and DAYLIGHT studies), diabetic retinopathy (phase 3 GLOW and GLOW2 studies) and macular edema following retinal vein occlusion (phase 3 BEACON study), according to the release.

“The strength of these DAYBREAK data positions us for the next stage of Kodiak's evolution, as we prepare for the planned commercialization of Zenkuda as a potential best-in-class therapy for patients with wet AMD, diabetic retinopathy and retinal vein occlusion,” Kodiak CEO Victor Perlroth, MD, said in the release. “The results generated in DAYBREAK with tabirafusp-ted are also highly encouraging, and we are enthusiastic to explore the potential for tabirafusp-ted to demonstrate superiority in patients with diabetic macular edema in the ongoing phase 3 ALTO pivotal program.”