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

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