AG-73305 / Allgenesis Biotherap - LARVOL DELTA

Emerging solutions for neovascular age-related macular degeneration. (PubMed, Curr Opin Ophthalmol) - "Therapeutic innovation in nAMD is transitioning from incremental refinements in intravitreal anti-VEGF delivery to strategies aimed at extending durability or targeting alternative contributory pathways. Long-term safety, efficacy, and durability will determine which of these candidates redefine standard care."

Journal • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • FGF2

A Single Ascending Dose Cohort Study of AG-73305 in DME Patients (clinicaltrials.gov) - P2 | N=25 | Completed | Sponsor: Allgenesis Biotherapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

AG-73305 Single Ascending Dose Cohort Study in DME (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: Allgenesis Biotherapeutics Inc. | Recruiting ➔ Active, not recruiting | Phase classification: P2a ➔ P2

Enrollment closed • Phase classification • Diabetic Macular Edema • Ophthalmology

A multicenter, open-labeled, phase 2a study of AG-73305, a novel bi-specific Fc-fusion protein for the treatment of diabetic macular edema (ARVO 2024) - "The results show that AG-73305 is safe and well-tolerated. A single intravitreal dose of AG-73305, with a novel bi-functional mechanism of action, showed improvement of BCVA and CST reduction lasting up to 24 weeks in DME patients; beyond what is expected from an anti-VEGF monotherapy. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • P2a data • Diabetic Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders

Phase 2a Study of AG-73305, a Novel Bispecific Anti-VEGF and Anti-Integrin Fc-Fusion Protein for the Treatment of DME (AAO 2023) - "Onset was as early as Week 1, and durability was observed over 3-5 months. Conclusion AG-73305, with a new mechanism of action and extended durability , has the potential to be safe and effective in the management of DME."

P2a data • Diabetic Macular Edema • Ophthalmology

AG-73305 Single Ascending Dose Cohort Study in DME (clinicaltrials.gov) - P2a | N=25 | Recruiting | Sponsor: Allgenesis Biotherapeutics Inc. | Trial completion date: Oct 2023 ➔ Oct 2024 | Trial primary completion date: May 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

Open-label Phase 2a study of AG-73305, a novel bi-specific Fc-fusion protein for the treatment of diabetic macular edema (ARVO 2023) - "One patient, who was a non-responder to bevacizumab, responded well to AG-73305 with BCVA improvement of 9 ETDRS letters. 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."

Clinical • P2a data • Diabetic Macular Edema • Ophthalmology • Retinal Disorders

AG-73305 Single Ascending Dose Cohort Study in DME (clinicaltrials.gov) - P2a | N=25 | Recruiting | Sponsor: Allgenesis Biotherapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology

AG-73305 Single Ascending Dose Cohort Study in DME (clinicaltrials.gov) - P2a | N=25 | Not yet recruiting | Sponsor: Allgenesis Biotherapeutics Inc.

New P2a trial • Diabetic Macular Edema • Ophthalmology