tabirafusp alfa (KSI-101) / Kodiak Sciences - LARVOL DELTA

Kodiak Sciences Inc. today announced that it has completed enrollment of the first 300-patient cohort in its PEAK trial, supporting Pivotal Analysis 1 of the KSI-101 Phase 3 program in macular edema secondary to inflammation (Yahoo Finance) - "Kodiak also reaffirmed its plan to release the topline data from Pivotal Analysis 1 in December 2026. Completion of enrollment in the second pivotal cohort evaluating 600 subjects across the PEAK and PINNACLE studies is expected in 4Q 2026, with topline clinical data release anticipated in 2Q 2027."

Enrollment status • P3 data: top line • Inflammation • Macular Edema

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Kodiak Sciences Inc | N=150 ➔ 300

Enrollment change • Inflammation • Macular Edema • Ophthalmology

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Kodiak Sciences Inc | N=150 ➔ 600 | Trial completion date: Jul 2027 ➔ Nov 2027 | Trial primary completion date: Feb 2026 ➔ Apr 2027

Enrollment change • Trial completion date • Trial primary completion date • Inflammation • Macular Edema • Ophthalmology

Kodiak Sciences to Present Pipeline Advances and KSI-101 Clinical Data, Including Results from a MESI Cohort in a Tertiary Care Uveitis Practice, at Upcoming Scientific Conferences (PRNewswire) - "Clinical results of KSI-101 in macular edema secondary to inflammation (MESI) from a tertiary care uveitis practice demonstrate outcomes consistent with results from the U.S. Phase 1b APEX study, supporting continued global development and expansion of the Phase 3 PEAK and PINNACLE program into Asia."

P1 data • Trial status • Macular Edema

Phase 1b APEX Data of KSI-101 in MESI, Including New Data from a Tertiary Care Cohort (PRNewswire) - "We will present first-time results from a clinical cohort of Asian patients with MESI treated at tertiary uveitis centers in Taiwan. Patients achieved meaningful visual improvements, including a ≥15-letter gain in 58% of patients and a mean BCVA increase of +17.8 letters at Week 24. Central subfield thickness (CST) was reduced to <325 µm after a single injection with sustained retinal dryness during follow-up. Improvements were observed across different underlying etiologies...In the Phase 1b APEX study over 24 weeks in patients with MESI, KSI-101 demonstrated robust and consistent anatomic and visual improvements. Over half of patients achieved at least ≥15-letter gains, and more than 90% of patients achieved resolution of both IRF and SRF by Week 8. Responses were consistent irrespective of different underlying etiologies."

P1 data • Macular Edema

KSI-101 - Phase 3 Programs Advancing (PRNewswire) - "Enrollment is progressing well in the Phase 3 PEAK and PINNACLE studies of KSI-101 in patients with macular edema secondary to inflammation (MESI), evaluating the 5 mg and 10 mg dose levels. Topline results from PEAK are expected in 4Q 2026. Topline results from PINNACLE are expected in 2Q 2027."

P3 data: top line • Macular Edema

Bispecific trap-antibody inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Phase 1b APEX study in patients with macular edema secondary to inflammation (MESI) (ARVO 2026) - "The final 24-week results will be presented at the meeting. Conclusions MESI patients in the APEX study demonstrated consistent and meaningful treatment responses to KSI-101 irrespective of location of inflammation or etiology of disease.Encouraging results from the APEX study have led to program acceleration for KSI-101, with two Phase 3 trials (PEAK & PINNACLE) initiated and actively enrolling."

Bispecific • Clinical • P1 data • Macular Edema • Ophthalmology • IL6

Bispecific trap-antibody inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Clinical PK/PD cohort in Asian patients with macular edema secondary to inflammation (MESI) (ARVO 2026) - "Detailed extended follow-up results will be presented at the meeting. Conclusions Clinical results from this Asian PK/PD study demonstrated meaningful and consistent treatment responses to KSI-101 irrespective of anatomic location of inflammation or underlying etiology, in line with findings from the APEX Phase 1b study conducted in the US.Encouraging results from these studies have led to expansion of the KSI-101 clinical development program to include Taiwanese investigators and hospitals in two global Phase 3 trials (PEAK & PINNACLE) initiated and actively enrolling."

Bispecific • Clinical • PK/PD data • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis • IL6

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

Results of the APEX phase 1b clinical study of KSI-101 for macular edema (Opthalmology) - "The end-of-trial week-24 data indicated that after treatment with KSI-101, there was some recurrence of intraretinal fluid. However, Sharma reported that 80% of eyes, even those in the 12-week off-treatment observation period, remained completely fluid-free throughout the 24-week period. In addition, the overall visual acuity data showed that the percentage of eyes that gained three lines of vision remained over 50% overall. For the 5-mg dose that percentage was 62% and for the 10-mg dose, 54%...The phase 1b results speak to the treatment’s durability, he pointed out, in that at the week 16 timepoint, which was 4 weeks after the previous injection, 96% of the eyes were fluid-free, and at week 24, 80% of those eyes were fluid-free."

P1 data • Macular Edema

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Kodiak Sciences Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Inflammation • Macular Edema • Ophthalmology

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Kodiak Sciences Inc | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2026 ➔ Feb 2026

Enrollment open • Trial primary completion date • Inflammation • Macular Edema • Ophthalmology

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Kodiak Sciences Inc

New P3 trial • Inflammation • Macular Edema • Ophthalmology

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Kodiak Sciences Inc

New P3 trial • Inflammation • Macular Edema • Ophthalmology

Ocular Toxicity Study of KSI-101 Demonstrates Tolerability after Intravitreal Administration in Cynomolgus Monkeys (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Ocular Inflammation • Ophthalmology • Retinal Disorders • IL6