Delving into the Latest Updates on Tarcocimab tedromer with Synapse

Overview

Basic Info

Drug Type

Antibody-biopolymer Conjugate (ABC)

Synonyms

tarcocimab tedromer, KSI 301, KSI-301

+ [1]

Target

VEGF-A

Action

inhibitors

Mechanism

VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)

Therapeutic Areas

Cardiovascular DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication

Inactive Indication

Macular EdemaNonproliferative diabetic retinopathyRetinal Vein Occlusion+ [2]

Originator Organization

Kodiak Sciences, Inc.

Active Organization

Kodiak Sciences, Inc.

Inactive Organization

Lifecore Biomedical LLC

License Organization

Kodiak Sciences, Inc.

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

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Sequence Code 103170L

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Sequence Code 13505697H

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A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Start Date23 Aug 2024

Sponsor / Collaborator

Kodiak Sciences, Inc.

NCT06270836

/ CompletedPhase 3

A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants With Diabetic Retinopathy (DR) - GLOW2

This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.

Start Date01 May 2024

Sponsor / Collaborator

Kodiak Sciences, Inc.

NCT05066230

/ TerminatedPhase 3

A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm Phase3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

Start Date07 Sep 2021

Sponsor / Collaborator

Kodiak Sciences, Inc.

100 Clinical Results associated with Tarcocimab tedromer

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100 Translational Medicine associated with Tarcocimab tedromer

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100 Patents (Medical) associated with Tarcocimab tedromer

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9

Literatures (Medical) associated with Tarcocimab tedromer

24 May 2025·EXPERT OPINION ON PHARMACOTHERAPY

Beyond the injection: delivery systems reshaping retinal disease management

Review

Author: Harris, Alon ; Ciulla, Thomas A. ; Akotoye, Christian ; Rowe, Lucas W.

INTRODUCTION:

Intravitreal injections remain the standard for treating common retinal diseases including age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy. However, frequent administration creates significant treatment burden due to limited drug half-life and the chronic nature of these conditions.

AREAS COVERED:

This review summarizes emerging drug delivery techniques and therapies for retinal disease that have achieved FDA approval within the past five years or have advanced to Phase 3 development, including intravitreal sustained-release platforms and alternative delivery routes (suprachoroidal, subretinal, topical, and subcutaneous). Specific innovations discussed include the ranibizumab port delivery system, EYP-1901 (Duravyu, vorolanib implant), KSI-301 (tarcocimab tedromer), KSI-501, OTX-TKI (Axpaxli, axitinib implant), 4D-150, revakinagene taroretcel-lwey (Encelto, NT-501, encapsulated cell therapy), Xipere (triamcinolone acetonide injectable suspension), AU-011 (belzupacap sarotalocan targeted delivery), ABBV-RGX-314, elamipretide, and OCS-01 (high concentration dexamethasone).

EXPERT OPINION:

Promising innovations include sustained-release intravitreal implants, topical and subcutaneous delivery systems, and targeted methods like suprachoroidal and subretinal injections, each with unique advantages and limitations. Challenges include overcoming the blood-retinal barrier, surgical complications with implantable devices, and ensuring patient adherence. Advances in smart delivery systems, drug formulations, and predictive models, alongside interdisciplinary collaboration, will be crucial in achieving personalized, effective, and sustainable retinal therapies.

01 Jan 2025·EYE

Exploring new horizons in neovascular age-related macular degeneration: novel mechanisms of action and future therapeutic avenues

Review

Author: Jonathan D. Shirian ; Priya Shukla ; Rishi P. Singh ; Shirian, Jonathan D. ; Singh, Rishi P. ; Shukla, Priya

Abstract:

Neovascular age-related macular degeneration (nAMD) can lead to significant vision impairment through the growth of abnormal neovascular membranes in the choroid. Despite advancements with current anti-vascular endothelial growth factor (VEGF) therapies, challenges such as frequent injections, inadequate response, and patient-related concerns persist. Emerging therapeutics aim to reduce vision-loss through a variety of mechanisms. Gene therapies, including RGX-314 and Ixo-vec, express an anti-VEGF protein, and 4D-150, expresses an anti-VEGF protein and a VEGF-C inhibitory miRNA. Anti-VEGF associated therapeutics include OPT-302, targeting VEGF-C and VEGF-D, BI 836880, which inhibits VEGF-A and Ang-2 activity, and Tarcocimab tedromer, inhibiting all VEGF-A isoforms. Agents with novel mechanisms of action include UBX1325, which inhibits an anti-apoptotic protein, Restoret (EYE103), a Wnt agonist, and the tyrosine kinase inhibitors, EYP-1901, OTX-TKI, CLS-AX, and KHK4951.

03 Oct 2022·Expert opinion on biological therapy

Efficacy and safety of intravitreal anti-VEGF therapy in diabetic retinopathy: what we have learned and what should we learn further?

Review

Author: Trong Tuong Than, Ngoc ; Hassan, Muhammad ; Akhavanrezayat, Amir ; Doan, Hien Luong ; Halim, Muhammad Sohail ; Pham, Brandon Huy ; Do, Diana V ; Chea, Sophaktra ; Matsumiya, Wataru ; Uludag, Gunay ; Nguyen, Quan Dong

INTRODUCTION:

Diabetic retinopathy (DR) is one of the most frequent microvascular complications of diabetes that can lead to blindness. Laser treatment has been the gold standard treatment for diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR) for many years. Recently, the role of vascular endothelial growth factor (VEGF) has been established in the pathogenesis of DR, and the use of intravitreal anti-VEGF therapy has gained popularity for the management of DR.

AREAS COVERED:

This review includes a brief overview of the efficacy and safety of currently available (bevacizumab, ranibizumab, and aflibercept) and potential future (brolucizumab, faricimab, and KSI-301) anti-VEGF agents in patients with DR based mainly on publicly available data from phase 1, 2 and 3 clinical trials.

EXPERT OPINION:

Clinical trials investigating the efficacy of intravitreal bevacizumab, ranibizumab, and aflibercept injections demonstrated favorable functional and anatomical outcomes in patients with DME. Moreover, the use of these anti-VEGF agents showed a significant improvement in the severity of DR. Recent clinical research for future anti-VEGF molecules aims to provide higher target-protein binding affinity and prolonged therapeutic effect. Brolucizumab, faricimab, and KSI-301 are three novel anti-VEGF agents that demonstrate promising data for the management of DME and potentially DR.

111

News (Medical) associated with Tarcocimab tedromer

07 Oct 2026

·www.prnewswire.com

Kodiak Sciences to Present Clinical Data Across All Three Late-Stage Programs at AAO 2026

First scientific presentation of Phase 3 DAYBREAK results for Zenkuda and tabirafusp-ted in wet age-related macular degeneration scheduled for AAO 2026. Additional presentations include Phase 3 GLOW2 data for Zenkuda in diabetic retinopathy and Phase 1b APEX data for KSI-101 in macular edema secondary to inflammation (MESI). PALO ALTO, Calif., Oct. 7, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced that clinical data across all three of its late-stage assets—Zenkuda (tarcocimab tedromer), tabirafusp-ted (KSI-501) and KSI-101— will be presented at the American Academy of Ophthalmology Annual Meeting (AAO 2026). The presentations will include the first scientific presentation of results from the pivotal Phase 3 DAYBREAK study of Zenkuda and tabirafusp-ted in patients with wet age-related macular degeneration (wet AMD), as well as Phase 3 GLOW2 data for Zenkuda in diabetic retinopathy and Phase 1b APEX data for KSI-101 in macular edema secondary to inflammation (MESI). At AAO 2026, Charles Wykoff, M.D., Ph.D., will present the DAYBREAK results during Retina Subspecialty Day on Friday, October 9, 2026. Kodiak announced topline results from DAYBREAK on September 28, 2026. The study met its primary endpoint for each investigational treatment, with both Zenkuda and tabirafusp-ted demonstrating non-inferior vision gains compared with aflibercept at Year 1. American Academy of Ophthalmology (AAO) 2026 – New Orleans; October 9-12, 2026 The following presentations will be held during Retina Subspecialty Day at AAO 2026. This will be the first scientific presentation of the Phase 3 DAYBREAK results in wet AMD. Title: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Wet Age-related Macular Degeneration: First-time One-year Primary Efficacy and Safety Outcomes of the Phase 3 DAYBREAK Study Presenter: Charles Wykoff, M.D., Ph.D., Chairman of Research at Retina Consultants of Texas and Professor of Clinical Ophthalmology and Deputy Chair of Ophthalmology at the Blanton Eye Institute, Houston Methodist Hospital Session: Section X, Clinical Trial Updates, Part I Date and time: Friday, October 9, 2026, at 4:40 PM CT Location: New Orleans Theater Title: GLOW2 Study: Phase 3 Study of Tarcocimab for Diabetic Retinopathy Presenter: Margaret Chang, M.D., M.S. Retina Consultants Medical Group, Sacramento, U.S. Session: Section XIX: Clinical Trial Updates, Part II Date and time: Saturday, October 10, 2026, at 4:51 PM CT Location: New Orleans Theater The following clinical presentation will be held during Uveitis Subspecialty Day at AAO 2026. Title: APEX Study Results: Intravitreal KSI-101 for Macular Edema Secondary to Inflammation Presenter: Edmund Tsui, M.D., M.S., FARVO, Associate Professor of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine at UCLA Session: Section VIII: A Uveitis Lagniappe: Late Breaking Topics Date and time: Friday, October 9, 2026, at 4:20 PM CT Location: Room 271 - 273 About Kodiak Sciences Inc. Kodiak Sciences (Nasdaq: KOD) is a pre-commercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally. We are developing a portfolio of three late-stage clinical programs. Zenkuda™ (tarcocimab tedromer) has a BLA-ready profile in diabetic retinopathy, retinal vein occlusion and wet AMD, and KSI-501 is being evaluated in wet AMD and diabetic macular edema. Zenkuda and KSI-501 target the $15 billion anti-VEGF market across retinal vascular diseases. KSI-101 is a bispecific protein being explored in two BLA-facing Phase 3 studies in Macular Edema Secondary to Inflammation (MESI). Topline data for Pivotal Analysis 1 (PEAK) are expected in December 2026 and Pivotal Analysis 2 (PEAK+PINNACLE) in 2Q 2027. Kodiak®, Kodiak Sciences®, ABC®, ABC Platform™, Zenkuda™, VETi™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. SOURCE Kodiak Sciences Inc. 21% more press release views with Request a Demo

Phase 3Clinical ResultPhase 1

02 Oct 2026

·www.biopharmadive.com

This week in charts: Kodiak’s big comeback and Hengrui’s dealmaking

This is the latest installment in a new series where BioPharma Dive uses data visualization to recap whats going on across the industry. Today, were looking at Kodiak Sciencess big return and Hengruis dealmaking prowess.More than four years ago, Kodiak Sciences suffered a near-extinction event: the failure of its lead asset in a head-to-head trial against Regeneron Pharmaceuticalseye disease drug Eylea. The event caused an 80% crash in its share price and erased $2 billion in market capitalization. That setback necessitated years of steady work and belief that the drug, now called Zenkuda, could actually perform as a longer-acting treatment than Eylea and Roches Vabysmo in the disorder wet age-related macular degeneration.That gamble paid off this week with data showing Zenkuda dosed at intervals as large as every six months was non-inferior to Eylea. A key component to its success was a tool that identified people likely to need more frequent injections based on fluid levels in the eyes.Kodiak saw its share price more than double, adding $3 billion in market value based on that data. The company plans on asking the Food and Drug Administration for approval by the end of the year.Kodiak's reboundKodiak's share price at close, since Jan. 1, 2022(function(){function e(){window.addEventListener(`message`,function(e){if(e.data[`datawrapper-height`]!==void 0){var t=document.querySelectorAll(`iframe`);for(var n in e.data[`datawrapper-height`])for(var r=0,i;i=t[r];r++)if(i.contentWindow===e.source){var a=e.data[`datawrapper-height`][n]+`px`;i.style.height=a}}})}e()})();Hengrui once again showed it is a destination for U.S. and European partners looking for clinical-stage experimental drugs when Novo agreed to pay it $300 million up front, and up to $2.6 billion total, for an oral obesity drug that could take on Eli Lillys sector-leading Zepbound.The deal is the sixth Hengrui has signed since early 2025 in disease areas that range from cardiovascular care to respiratory diseases to reproductive medicine. But it also comes amid heightened scrutiny of transactions between U.S. drugmakers and Chinese partners, as well as efforts to take away Chinas perceived advantages in early drug development.Hengrui's prolific dealmakingDeals between Hengrui and Western drugmakers since the start of 2025(function(){function e(){window.addEventListener(`message`,function(e){if(e.data[`datawrapper-height`]!==void 0){var t=document.querySelectorAll(`iframe`);for(var n in e.data[`datawrapper-height`])for(var r=0,i;i=t[r];r++)if(i.contentWindow===e.source){var a=e.data[`datawrapper-height`][n]+`px`;i.style.height=a}}})}e()})(); '

Biosimilar

28 Sep 2026

·www.fiercebiotech.com

Kodiak's stock doubles with win for resurrected eye disease drug

Two of Kodiak Sciences’ drug candidates have matched Eylea in a phase 3 clinical trial, positioning the biotech to seek FDA approval of one of the eye disease assets this year. The Daybreak study compared tarcocimab tedromer and tabirafusp alfa tedromer to aflibercept, a VEGF inhibitor that Regeneron sells as Eylea, in wet age-related macular degeneration (wAMD). After one year of treatment, both of Kodiak's candidates performed as well as aflibercept on the primary endpoint, which assessed vision gains. Investors seemed pleased, sending the biotech's stock up 128% to $72.99 when markets opened Monday from a Friday closing price of $32.35. Kodiak plans to file for FDA approval of tarcocimab, an anti-VEGF drug also called Zenkuda, in the fourth quarter. The multi-indication submission will include results from five phase 3 trials in wAMD, diabetic retinopathy and retinal vein occlusion. “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,” Houston Methodist Hospital’s Charles Wykoff, M.D., Ph.D., a surgical retina specialist, said in a statement. Kodiak used an AI-guided retreatment algorithm to inform tarcocimab dosing. More than half of the patients were maintained on 24-week dosing through year one. Patients on aflibercept received treatment every eight weeks. The biotech has yet to share detailed Daybreak data comparing tarcocimab to the control, although it said the drug candidate showed “strong immediacy of clinical effect, matching and/or exceeding that of the aflibercept comparator through the loading phase.” Kodiak also reported strong durability of clinical effect and a favorable safety profile, with a numerically lower rate of cataracts than aflibercept. An “unexpected increase in cataracts” temporarily ended tarcocimab development in 2023. The biotech restarted development later that year in response to non-proliferative diabetic retinopathy data. Buoyed by the readout, Kodiak embarked on a renewed late-phase program that has taken it to the cusp of an FDA filing. While investors were enthusiastic, the topline readout left unanswered questions about tarcocimab’s chances in a competitive field. Patents on aflibercept have expired, meaning Kodiak will compete with biosimilars such as Biocon’s Yesafili. As well as contending with lower-cost biosimilar competition, Kodiak will face up against branded rivals such as Regeneron’s Eylea HD and Roche’s Vabysmo. Kodiak’s Daybreak press release focused on tarcocimab rather than tabirafusp, an anti-IL-6, VEGF-trap bispecific therapy. Like tarcocimab, tabirafusp matched aflibercept on the primary endpoint. Kodiak will run post-hoc analyses to identify which treatment-naïve wAMD patient sub-groups can benefit from IL-6 inhibition. A phase 3 superiority trial is comparing tabirafusp to aflibercept in diabetic macular edema.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Tarcocimab tedromer

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External Link

KEGG	Wiki	ATC	Drug Bank
D12508	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonproliferative diabetic retinopathy	Phase 3	United States	Kodiak Sciences, Inc.	07 Sep 2021
Nonproliferative diabetic retinopathy	Phase 3	Czechia	Kodiak Sciences, Inc.	07 Sep 2021
Nonproliferative diabetic retinopathy	Phase 3	Latvia	Kodiak Sciences, Inc.	07 Sep 2021
Nonproliferative diabetic retinopathy	Phase 3	Poland	Kodiak Sciences, Inc.	07 Sep 2021
Nonproliferative diabetic retinopathy	Phase 3	Slovakia	Kodiak Sciences, Inc.	07 Sep 2021
Nonproliferative diabetic retinopathy	Phase 3	Spain	Kodiak Sciences, Inc.	07 Sep 2021
Diabetic macular oedema	Phase 3	United States	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	Czechia	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	France	Kodiak Sciences, Inc.	30 Sep 2020
Diabetic macular oedema	Phase 3	Germany	Kodiak Sciences, Inc.	30 Sep 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04611152 (GLEAM, CTgov)	Phase 3	Diabetic macular oedema \| Vision, Low	460	Sham Procedure+KSI-301 (KSI-301 (Arm A))	tsazalcxur(fexhruntdp) = ngcxcoeqne zeyncleggy (rsnbacarvy, 0.83) View more	-	22 Aug 2024
				Sham Procedure+Aflibercept (Aflibercept (Arm B))	tsazalcxur(fexhruntdp) = itthchetqe zeyncleggy (rsnbacarvy, 0.85) View more
NCT04603937 (GLIMMER, CTgov)	Phase 3	Diabetic macular oedema \| Vision, Low	459	Sham Procedure+KSI-301 (KSI-301 (Arm A))	mlscvzqham(dfnegnrmfu) = vshlezrdzu otfasxujok (tdvvikjaxk, 0.80) View more	-	22 Aug 2024
				Sham Procedure+Aflibercept (Aflibercept (Arm B))	mlscvzqham(dfnegnrmfu) = yyyrcijtrb otfasxujok (tdvvikjaxk, 0.81) View more
NCT04049266 (DAZZLE, CTgov)	Phase 2/3	Wet age-related macular degeneration \| Wet Macular Degeneration	559	Sham Procedure+KSI-301 (KSI-301 5 mg)	ldsvnqcufi = tyxstcmsog zzrqrwkmhc (skkhkrjpfj, semgdnlcne - kexzzlqccl) View more	-	18 Jul 2024
				Sham Procedure+Aflibercept (Aflibercept 2 mg)	ldsvnqcufi = rdkxvnakzy zzrqrwkmhc (skkhkrjpfj, xqvmhkvmwl - xcxtxblhoh) View more
NCT04592419 (BEACON, CTgov)	Phase 3	Retinal Vein Occlusion \| Macular Edema \| Vision, Low	568	Sham Procedure+KSI-301 (KSI-301 (Arm A))	afxynugjuz(ffyrgesrqt) = fdgpvdkisd haipdziwua (pcgsskunyd, .81) View more	-	06 Jun 2024
				Sham Procedure+Aflibercept (Aflibercept (Arm B))	afxynugjuz(ffyrgesrqt) = uphcpqneci haipdziwua (pcgsskunyd, .79) View more
NCT04964089 (DAYLIGHT, CTgov)	Phase 3	Wet age-related macular degeneration	557	KSI-301 (KSI-301 (Treatment Group A))	touliuajjo(pzaykvxptl) = qoonjxgalf wtkxlfavjk (rohsrxnngu, 0.78) View more	-	02 May 2024
				Sham Procedure+Aflibercept (Aflibercept (Treatment Group B))	touliuajjo(pzaykvxptl) = dyqgnetgoa wtkxlfavjk (rohsrxnngu, 0.76) View more
NCT05066230 (GLOW, PRNewswire) Manual	Phase 3	Nonproliferative diabetic retinopathy	253	tarcocimab tedromer	tkhpgqatah(ikzfyfthkj) = thjkzbvylj grectotiph (vxwgrrdfyo ) View more	Positive	06 Nov 2023
				placebo	tkhpgqatah(ikzfyfthkj) = weowyrkulb grectotiph (vxwgrrdfyo ) View more
NCT04592419 (BEACON, Corporate Publications) Manual	Phase 3	Retinal Vein Occlusion	568	tarcocimab tedromer	symjnuzuhd(ucopinsfgo): P-Value = 0.0004 View more	Non-inferior	08 Aug 2022
				Aflibercept
NCT04049266 (DAZZLE, Corporate Publications) Manual	Phase 2/3	Wet age-related macular degeneration First line	559	Tarcocimab tedromer	oxnnjghfxy(kcltyqiafy) = lflgwkjhpo jsmpcsvbfa (iqeetpvuev ) View more	Negative	23 Feb 2022
				Aflibercept	oxnnjghfxy(kcltyqiafy) = szkjvouejs jsmpcsvbfa (iqeetpvuev ) View more
NCT03790852 (ARVO2020)	Phase 1	Diabetic macular oedema \| Retinal Vein Occlusion \| Wet age-related macular degeneration	109	KSI-301 2.5 mg	yedtnhrqys(iszjwepjms) = no drug-related adverse events after 338 doses sajvbnvwty (sqmvlgdwfx ) View more	-	01 Jun 2020
				KSI-301 5 mg

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Tarcocimab tedromer

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation