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KODIAK Zenkuda and tabirafusp - ted Meet Primary Endpoints in Pivotal DAYBREAK Trial in wAMD , with Zenkuda Demonstrating a Potential New Standard - of - Care Profile with Strong Immediacy and Sustained Clinical Effect with Majority of Patients on 24 - week Dosing Interval Using Strict Treat- to - Dryness Real World Retreatment Criteria . September 28 , 2026 at 6:30 AM EDT • Zenkuda ( tarcocimab tedromer ) met the primary endpoint ( p - value of 0.0007 ) demonstrating meaningful vision gains as well as rapid and sustained retinal drying with the majority of patients ( 54 % ) on 6 - month dosing , establishing a first - line benchmark in wet age - related macular degeneration ( WAMD ) • Zenkuda multi - indication biologics license application ( BLA ) planned for the fourth quarter of 2026 to include five positive Phase 3 studies across wAMD , diabetic retinopathy and retinal vein occlusion • Tabirafusp alfa tedromer ( tabirafusp - ted ) met the vision primary endpoint ( p - value of 0.0036 ) and anatomical key secondary endpoint ( p - value of < 0.0001 ) • Post - hoc analyses to identify which treatment naïve wAMD patient sub - groups can benefit from IL - 6 inhibition are planned . Tabirafusp - ted development program is accelerating in diabetic macular edema and actively enrolling in the ALTO Phase 3 Study • Zenkuda and tabirafusp - ted demonstrated safety consistent with the established safety profile of aflibercept PALO ALTO , Calif . , Sept. 28 , 2026 / PRNewswire / -- Kodiak Sciences Inc. ( Nasdaq : KOD ) , a precommercial retina - focused biotechnology company committed to researching , developing and commercializing transformative therapeutics , today announced that the primary endpoints were met for both Zenkuda ( tarcocimab tedromer ) and tabirafusp - ted ( KSI - 501 ) in the Phase 3 DAYBREAK study in patients with wet age - related macular degeneration ( WAMD ) . The DAYBREAK study in wAMD demonstrated that both Zenkuda and tabirafusp - ted achieved non - inferiority in vision gains compared to aflibercept at year one . In DAYBREAK , Zenkuda demonstrated strong immediacy of clinical effect , matching and / or exceeding that of the aflibercept comparator through the loading phase . Zenkuda also demonstrated strong durability of clinical effect , with 54 % of patients achieving 6 - month durability at year one , while employing strict treat - to - dryness real world retreatment criteria . Zenkuda demonstrated favorable safety and was well tolerated in the study with a 0 % intraocular inflammation rate and a 0.5 % cataract adverse event rate ( vs 0.9 % with aflibercept comparator ) . Tabirafusp - ted also demonstrated favorable safety and was well tolerated in the study with a 0.4 % intraocular inflammation rate and a 0 % cataract adverse event rate ( vs 0.9 % with aflibercept ) . Kodiak plans to submit Zenkuda data to regulatory authorities in 4Q2026 from five positive Phase 3 studies , DAYBREAK and DAYLIGHT in WAMD , GLOW and GLOW2 in diabetic retinopathy ( DR ) and BEACON in macular edema following retinal vein occlusion ( RVO ) . " 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 , " said Victor Perlroth , M.D. , Chief Executive Officer of Kodiak Sciences . " 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 ( DME ) in the ongoing Phase 3 ALTO pivotal program . Our third late - stage asset , KSI - 101 , is being developed for macular edema secondary to inflammation , or MESI , with our first topline readout from its Phase 3 program expected in December 2026. Together , these three assets reflect the breadth of our late - stage opportunity and ambition to build a leading retinal medicines company with multiple therapies capable of providing meaningful and durable benefits to patients , " continued Dr. Perlroth . " These strong DAYBREAK data also have important ramifications for our ABC pipeline programs , as they reinforce the potential of our science and our ABC Platform to support a widening portfolio of proprietary and multi - functional medicines , " concluded Dr. Perlroth . " Today's results are deeply satisfying , " said J. Pablo Velazquez - Martin , M.D. , Chief Medical Officer . " Four years and seven months after our first Phase 3 readout , Zenkuda's profile has come fully into focus through rigorous science , disciplined learning and thoughtful execution . DAYBREAK demonstrated the attributes we designed Zenkuda to achieve : rapid disease control in wet AMD and the potential for six - month durability under stringent treat - to - dryness retreatment criteria . Together with our Phase 3 results in diabetic retinopathy and macular edema secondary to retinal vein occlusion , we now have five successful pivotal studies supporting Zenkuda's broad potential across major retinal vascular diseases . " " We plan to submit the BLA for Zenkuda later this year . We also look forward to reporting Phase 3 results from the first MESI study of KSI - 101 , and we are advancing tabirafusp - ted in diabetic macular edema , a high - inflammation disease , through the ongoing Phase 3 ALTO pivotal program . " continued Dr. Velazquez - Martin . Charles Wykoff , M.D. , Ph.D. , Chairman of Research , Retina Consultants of Texas , Professor of Clinical Ophthalmology and Deputy Chair of Ophthalmology , Blanton Eye Institute , Houston Methodist Hospital , said : " The Zenkuda results exceeded my expectations , delivering the clinical profile retina specialists are seeking : rapid vision and anatomic improvements comparable to aflibercept during loading , followed by meaningfully longer intervals between treatment for a majority of patients , while maintaining optimal fluid control . More than half of patients reached a 24 - week dosing interval using strict treat - to - dry retreatment criteria . This combination of immediacy , flexibility and true durability is unique and differentiated . " " The observed safety profile also appears consistent with expectations for aflibercept . Kodiak persevered through real challenges with the tarcocimab development program , incorporating multiple lessons learned , culminating in a successful DAYBREAK trial . These findings add to an extensive Phase