Restoret (EYE103) / Merck (MSD) - LARVOL DELTA

Super Tuscan: A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: EyeBiotech Ltd.

New P2 trial • Age-related Macular Degeneration • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

BRUNELLO: A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME (clinicaltrials.gov) - P2/3 | N=984 | Active, not recruiting | Sponsor: EyeBiotech Ltd. | Trial primary completion date: Dec 2027 ➔ Sep 2026

Trial primary completion date • Diabetic Macular Edema • Ophthalmology

BRUNELLO: A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME (clinicaltrials.gov) - P2/3 | N=960 | Active, not recruiting | Sponsor: EyeBiotech Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology

BAROLO: A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME (clinicaltrials.gov) - P2/3 | N=960 | Recruiting | Sponsor: EyeBiotech Ltd.

New P2/3 trial • Diabetic Macular Edema • Ophthalmology

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

Restoret (EYE103) for the Treatment of Diabetic Macular Edema and Neovascular AMD: First-time Extended Results From the AMARONE Phase 1b/2a Clinical Trial (AAO 2024) - No abstract available

Clinical • P1/2 data • Age-related Macular Degeneration • Diabetic Macular Edema • Ophthalmology • Wet Age-related Macular Degeneration

Merck and EyeBio Announce Initiation of Phase 2b/3 Clinical Trial for Restoret™ for the Treatment of Diabetic Macular Edema (Businesswire) - "Merck...and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA, today announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME)."

Trial status • Diabetic Macular Edema • Macular Edema • Ophthalmology

AMARONE: A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD) (clinicaltrials.gov) - P1/2 | N=33 | Completed | Sponsor: EyeBiotech Ltd. | Recruiting ➔ Completed | N=92 ➔ 33 | Trial completion date: Dec 2024 ➔ Aug 2024 | Trial primary completion date: Dec 2024 ➔ Aug 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

BRUNELLO: A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME (clinicaltrials.gov) - P2/3 | N=960 | Recruiting | Sponsor: EyeBiotech Ltd.

New P2/3 trial • Diabetic Macular Edema • Ophthalmology

AMARONE: A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD) (clinicaltrials.gov) - P1/2 | N=92 | Recruiting | Sponsor: EyeBiotech Ltd.

New P1/2 trial • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration