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

Merck’s Remigromig, a Tri-specific Agonist of the Wingless-related Integration Site (Wnt) Pathway, Met Primary Endpoint in the Pivotal Phase 2b/3 BRUNELLO Study of Adults with Diabetic Macular Edema (Yahoo Finance) - "At 52 weeks, both doses of remigromig (0.5 mg and 0.8 mg) independently demonstrated non-inferiority to active control 0.5 mg ranibizumab for mean change from baseline in best-corrected visual acuity (BCVA) in patients with DME. In addition, both doses of remigromig were generally well tolerated. Higher rates of proliferative diabetic retinopathy (PDR), vitreous hemorrhage, and treatment discontinuations due to adverse events were observed in the remigromig treatment arms compared with ranibizumab. Further analyses are underway to characterize these findings...The BRUNELLO year one results will be presented at the American Academy of Ophthalmology (AAO) Annual Meeting in New Orleans, Saturday, Oct. 10, at 5:10 p.m. CT."

P2/3 data • Diabetic Macular Edema

Wnt Pathway Agonism as a Therapeutic Strategy for Retinal Vascular Diseases: A Narrative Review of Evidence to Date. (PubMed, Ophthalmol Ther) - "There are several potential therapeutics for retinal vascular diseases targeting the Wnt/β-catenin pathway under investigation, including several in preclinical development and one (MK-3000; also known as Restoret and formerly EYE103) with early clinical trial results advancing to late-stage clinical development. In this narrative review we examine the role of Wnt/β-catenin signaling in inner BRB maintenance and in retinal vascular diseases, as well as the potential for Wnt pathway agonism as a therapeutic approach."

Journal • Review • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

BAROLO: A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME (clinicaltrials.gov) - P2/3 | N=1054 | Active, not recruiting | Sponsor: EyeBiotech Ltd. | Trial completion date: Jun 2028 ➔ Mar 2028 | Trial primary completion date: Jun 2028 ➔ Mar 2027

Trial completion date • Trial primary completion date • 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=1054 | Active, not recruiting | Sponsor: EyeBiotech Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology

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