Zenkuda (tarcocimab tedromer) / Kodiak Sciences - LARVOL DELTA

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) (PRNewswire) - "The company is planning to submit a three-indication BLA for Zenkuda in 4Q2026....We also remain on track to announce topline data in December 2026 for KSI-101 in the Phase 3 PEAK study in patients with macular edema secondary to inflammation (MESI), in which KSI-101 is being evaluated for superiority against sham-treated patients. We are planning to file a BLA for KSI-101 in the second quarter of 2027. Looking to Zenkuda and KSI-101, we have the potential to receive marketing authorization for two retinal medicines by the end of calendar year 2027 or early 2028."

FDA approval • FDA filing • P3 data • Diabetic Retinopathy • Macular Edema • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

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. (PRNewswire) - "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)."

P3 data • Wet Age-related Macular Degeneration

Kodiak Sciences to Present Topline Results on September 28, 2026 from DAYBREAK Pivotal Phase 3 Study of Zenkuda and KSI-501 in Patients with Wet Age-Related Macular Degeneration (PRNewswire)

P3 data: top line • Wet Age-related Macular Degeneration

Kodiak continues execution of the Phase 3 DAYBREAK study evaluating both Zenkuda and KSI-501 in patients with treatment-naïve wet age-related macular degermation (wet AMD) (PRNewswire) - "Topline data for the one-year primary endpoint (Zenkuda and KSI-501) are expected in September 2026."

P3 data: top line • Wet Age-related Macular Degeneration

GLOW2: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR) (clinicaltrials.gov) - P3 | N=255 | Completed | Sponsor: Kodiak Sciences Inc | Active, not recruiting ➔ Completed

Trial completion • Diabetic Retinopathy • Retinal Disorders

Phase 3 DAYBREAK Study - Topline Data Expected September 2026 (PRNewswire) - "Enrollment in the DAYBREAK Phase 3 study of both Zenkuda and KSI-501 in patients with treatment-naive neovascular age-related macular degeneration (wet AMD) was completed with approximately 690 subjects enrolled. Topline data from the one-year primary endpoint for DAYBREAK are expected in September 2026, evaluating both Zenkuda and KSI-501."

Enrollment closed • P3 data: top line • Wet Age-related Macular Degeneration

Kodiak Sciences Announces Positive Topline Results in GLOW2, the Second Phase 3 Study in Diabetic Retinopathy, Demonstrating Superiority of Zenkuda (tarcocimab tedromer) Over Sham (PRNewswire) - "A total of 62.5% of patients treated with Zenkuda achieved a ≥2-step improvement in DRSS score at Week 48, compared with 3.3% in the sham group, meeting the primary endpoint of superiority to sham with high statistical significance (p<0.0001)...Zenkuda demonstrated superiority in the key secondary endpoint of reducing the risk of developing prespecified sight-threatening complications, including new or worsening proliferative DR or center-involving DME, by 85% compared to sham through Week 48 (2.4% with Zenkuda versus 15.8% with sham, p=0.0001)....The full end-of-study results will be presented at an upcoming congress by Dr. Charles Wykoff."

P3 data: top line • Diabetic Retinopathy

Based on the strong safety, efficacy and durability data demonstrated in the GLOW2 study, Zenkuda now has a multi-indication Biologics License Application (BLA)-ready profile, and Kodiak intends to accelerate the BLA submission timeline. (PRNewswire) - "'Leaning into FDA's new single-pivotal-trial default option for approval, we are also anticipating a potential BLA submission for KSI-501 in wet AMD after the DAYBREAK study primary endpoint readout (expected 3Q2026, if successful) and for KSI-101 in Macular Edema Secondary to Inflammation (MESI) after the PEAK study pivotal analysis 1 readout (expected 4Q2026, if successful).'...'four different Phase 3 studies with three readouts expected in 2026...'"

Clinical data • FDA filing • Diabetic Retinopathy • Macular Edema • Ocular Inflammation • Wet Age-related Macular Degeneration

Tarcocimab – Phase 3 topline data expected in 1Q 2026 (6 months) and 3Q 2026 (12 months) (PRNewswire) - "Phase 3 GLOW2 diabetic retinopathy study...Phase 3 DAYBREAK wet AMD study....Completed the manufacturing and release of BLA-facing commercial-scale batches in Kodiak's URSUS facility."

P3 data: top line • Diabetic Retinopathy • Wet Age-related Macular Degeneration

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) - DAYBREAK (clinicaltrials.gov) - P3 | N=675 | Active, not recruiting | Sponsor: Kodiak Sciences Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2027 ➔ Aug 2027 | Trial primary completion date: Apr 2026 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Beyond the injection: delivery systems reshaping retinal disease management. (PubMed, Expert Opin Pharmacother) - "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)...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."

Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders

GLOW2: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR) (clinicaltrials.gov) - P3 | N=255 | Active, not recruiting | Sponsor: Kodiak Sciences Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Retinopathy • Retinal Disorders

DAYBREAK Phase 3 study (PRNewswire) - "We remain focused on completing enrollment in our ongoing DAYBREAK Phase 3 study to broaden the efficacy profile for tarcocimab in wet age-related macular degeneration ('wet AMD'), and it is our plan to wait for DAYBREAK topline data expected in 2Q 2026 in order to file a single BLA for tarcocimab in wet AMD..."

P3 data: top line • Trial status • Wet Age-related Macular Degeneration

Kodiak Sciences Completes Enrollment in Second Registrational Trial of Tarcocimab in Patients with Diabetic Retinopathy (PRNewswire) - "Kodiak Sciences...announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with diabetic retinopathy ('DR')....'We randomized more than 250 patients into our GLOW2 Phase 3 study, exceeding our enrollment target', said Victor Perlroth, M.D., Chief Executive Officer of Kodiak. 'With its 48-week duration of treatment, all patients are expected to complete their primary endpoint visits by the end of January 2026, and we expect to announce topline clinical data in 1Q 2026'."

P3 data: top line • Trial status • Diabetic Retinopathy

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) - DAYBREAK (clinicaltrials.gov) - P3 | N=675 | Recruiting | Sponsor: Kodiak Sciences Inc | Trial completion date: Jan 2026 ➔ Apr 2027 | Trial primary completion date: Jan 2026 ➔ Apr 2026

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Kodiak Sciences Announces Recent Business Highlights and Third Quarter 2024 Financial Results (PRNewswire) - "'It is our objective to complete enrollment for the Phase 3 GLOW2 and DAYBREAK studies of tarcocimab and KSI-501 in the first half of 2025, so we and all Kodiak stakeholders can have a clear line of sight to our 48-week topline data readouts....The decrease in R&D expenses for the third quarter of 2024, as compared to the same period in 2023, was primarily driven by reduced manufacturing activities, decreased clinical activities for completed trials, partially offset by costs from active clinical trials for the tarcocimab development program as well as expanding clinical activities for KSI-501 and KSI-101."

Commercial • Enrollment status • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Edema • Ophthalmology • Wet Age-related Macular Degeneration

Exploring new horizons in neovascular age-related macular degeneration: novel mechanisms of action and future therapeutic avenues. (PubMed, Eye (Lond)) - "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."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • VEGFC • VEGFD

Intraocular drugs: pharmacokinetic strategies and the influence on efficacy and durability. (PubMed, Expert Opin Drug Metab Toxicol) - "Durability strategies include inhibiting additional pathways (faricimab), increasing molar dose (abicipar, brolucizumab, faricimab, and aflibercept 8 mg), and prolonging the intravitreal half-life (abicipar and KSI-301). Recent phase 3 trials demonstrated modest improvements in durability, but failures that might be attributed to these strategies (conjugation and manufacturing processes) have occurred. Future drug development focuses on extending duration of action with implantable reservoirs (ranibizumab port delivery system), sustained release devices (tyrosine kinase inhibitors), and gene therapy."

Journal • PK/PD data • Review • Gene Therapies

Kodiak Sciences Announces Recent Business Highlights and Second Quarter 2024 Financial Results (PRNewswire) - "Following submission of the study protocol to the FDA in the first quarter of 2024, we began to operationalize the study including site selection in the second quarter of this year. The DAYBREAK Phase 3 study is now actively enrolling patients....Research and development (R&D) expenses were $32.5 million for the second quarter of 2024, as compared to $67.0 million for the second quarter of 2023. The R&D expenses for the second quarter of 2024 included non-cash stock-based compensation of $8.9 million, as compared to $14.7 million for the second quarter of 2023. The decrease in R&D expenses for the second quarter of 2024, as compared to the same period in 2023, was primarily driven by reduced manufacturing and clinical activities for tarcocimab."

Commercial • Enrollment status • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Wet Age-related Macular Degeneration

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) - DAYBREAK (clinicaltrials.gov) - P3 | N=675 | Recruiting | Sponsor: Kodiak Sciences Inc

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

DAZZLE: A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (clinicaltrials.gov) - P2/3 | N=559 | Terminated | Sponsor: Kodiak Sciences Inc | Phase classification: P2b ➔ P2/3

Phase classification • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Kodiak Sciences Announces Treatment of First Patients in Phase 3 GLOW2 Study of Tarcocimab Tedromer in Diabetic Retinopathy (PRNewswire) - "Kodiak Sciences...announced today that the first patients with diabetic retinopathy (DR) have been treated in the randomized double masked Phase 3 GLOW2 study of tarcocimab tedromer. GLOW2 is the second Phase 3 study of tarcocimab in diabetic retinopathy in which all patients on investigational therapy will receive tarcocimab on extended dosing intervals, including 6-month dosing for all patients."

Trial status • Diabetic Retinopathy

Perspectives on the currently available pharmacotherapy for wet macular degeneration. (PubMed, Expert Opin Pharmacother) - "Promising developments include extending treatment intervals with newer anti-VEGF agents like brolucizumab and faricimab, biosimilars offering cost-effective options, and exploring innovative drug delivery methods such as subretinal gene therapy. Combination therapies, gene therapies, and novel agents like KSI-301 and OPT-302 show potential for improving treatment outcomes and reducing treatment burden. While current treatments for w-AMD have significantly advanced with the advent of anti-VEGF therapies, their limitations in terms of treatment burden and incomplete responses have spurred research into diverse alternative approaches. These innovative strategies offer hope for improving patient outcomes and reducing healthcare burdens, suggesting a promising future for w-AMD management."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Kodiak Sciences Data at ARVO 2024 Highlight Depth of Early and Late-Phase Retina Pipeline including Advancements with High Drug-Antibody-Ratio Therapeutics Built on Kodiak's Antibody Biopolymer Conjugate (ABC) Platform (PRNewswire) - P3 | N=253 | GLOW (NCT05066230) | Sponsor: Kodiak Sciences Inc | "Kodiak Sciences Inc...announced today that nine scientific presentations on its clinical and research pipeline programs will be made at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting, being held from May 5 – 9 in Seattle, Washington....Kodiak's GLOW1 study with tarcocimab showed for the first time that a therapeutic agent dosed in all patients on an every 6-month interval can successfully treat and prevent disease worsening in DR patients. Tarcocimab offers the hope of an achievable prevention and treatment strategy in real-world clinical practice for DR patients at risk of vision loss. Currently, the Phase 3 GLOW2 study is enrolling patients with DR, with the goal to enable tarcocimab's marketing authorization application."

Enrollment status • P3 data • Diabetic Retinopathy • Ophthalmology

Kodiak Sciences Data at ARVO 2024 Highlight Depth of Early and Late-Phase Retina Pipeline including Advancements with High Drug-Antibody-Ratio Therapeutics Built on Kodiak's Antibody Biopolymer Conjugate (ABC) Platform (PRNewswire) - P3 | N=253 | GLOW (NCT05066230) | Sponsor: Kodiak Sciences Inc | "The prespecified analysis of the GLOW1 study demonstrated that both the tarcocimab treatment arm and sham arm had negligible change in systemic metabolic control as measured by HbA1c levels, and both arms showed similar distribution of change in HbA1c from baseline to primary endpoint at Week 48. These results suggest that subjects in the tarcocimab arm achieved superiority in ≥2-step improvement in DRSS over sham injections irrespective of baseline and systemic metabolic control, as evidenced by HbA1c levels, and any potential presumed knowledge by the patient about treatment assignment due to the use of sham as a comparator did not systematically influence their glycemic control."

P3 data • Diabetic Retinopathy • Ophthalmology