zifibancimig (RG6120) / Roche - LARVOL DELTA

Roche also disclosed this morning that it had dropped a trio of candidates from its phase 1 pipeline, including an in-house antibody against VEGF and angiopoietin 2 called zifibancimig. (FierceBiotech) - "The pharma had been evaluating the antibody in a phase 1/2 study of patients with an eye disease called neovascular age-related macular degeneration. The drug was administered with Roche’s Port Delivery system, an FDA-approved, surgically inserted ocular implant...The company explained to Fierce that it had 'decided to phase out' the zifibancimig program after an interim data review showed it had a 'very low probability of meeting the high bar for safety, durability, and efficacy required for a therapy that would ensure a strong enough benefit for patients in need.'"

Discontinued • P1/2 data • Age-related Macular Degeneration

BURGUNDY: Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P1/2 | N=177 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2028 ➔ Aug 2026 | Trial primary completion date: Feb 2027 ➔ Aug 2026 | Recruiting ➔ Active, not recruiting

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

BURGUNDY: Study of Zifibancimig in Participants With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P1/2 | N=251 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Feb 2026 ➔ Feb 2027

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

Characterization of a Tailored Bi-Specific DutaFab, Zifibancimig, for Neutralizing Both VEGF-A and Ang-2, and Continuous Ocular Delivery (ARVO 2025) - "Ocular PK and target engagement following a single intravitreal dose of zifibancimig (50, 100 or 500 μg/eye) were compared with equimolar doses of VEGF/Ang-2 bispecific CrossMab (faricimab-surrogate; 150, 300 or 1500 μg/eye) in cynomolgus monkeys. 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."

Ophthalmology • Retinal Disorders • ANGPT1 • VEGFA

BURGUNDY: Study of Zifibancimig in Participants With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P1/2 | N=251 | Recruiting | Sponsor: Hoffmann-La Roche | Phase classification: P1 ➔ P1/2

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

BURGUNDY: Study of Zifibancimig in Participants With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P1 | N=251 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Mar 2027 ➔ Dec 2027 | Trial primary completion date: May 2025 ➔ Feb 2026

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

BURGUNDY: Study of RO7250284 in Participants With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P1 | N=251 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Nov 2025 ➔ Mar 2027 | Trial primary completion date: Nov 2025 ➔ May 2025

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

Study of RO7250284 in Participants With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P1 | N=190 | Recruiting | Sponsor: Hoffmann-La Roche | N=50 ➔ 190

Enrollment change • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study of RO7250284 in Participants With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Mar 2026 ➔ Nov 2025; Trial primary completion date: Mar 2026 ➔ Nov 2025

Clinical • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study of RO7250284 in Participants With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study of RO7250284 in Participants With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Hoffmann-La Roche

Clinical • New P1 trial • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration