Eyebiotech Limited (EyeBio) has dosed the first patients in a phase 1b/2 trial assessing the safety and preliminary efficacy of intravitreal Restoret (EYE103) in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD).
Give me a rundown on Restoret first.
Restoret (EYE103) is a tetravalent, tri-specific antibody that behaves as an agonist of the Wingless-related integration site (Wnt) signaling pathway, which is part of a group of signal transduction pathways beginning with proteins that pass signals into a cell through cell surface receptors.
Click here to see why the Wnt pathway is important.
Exactly how does it work?
The antibody is delivered via intravitreal injections for retinal vascular diseases with leakage (such as wet AMD, DME, and familial exudative vitreoretinopathy [FEVR]).
Restoret removes this leakage by forcing the Wnt pathway to potentially restore and maintain the blood retinal barrier (BRB).
Now tell me about this study.
The multicenter, open-label, phase 1b/2 Anti-permeability Mechanism and Age-Related Ocular Neovascularization Evaluation (AMARONE) trial is a two-part trial:
Part 1 → Multiple-ascending dose (MAD) safety study
Part 2 → Dose-finding, single-masked comparative safety and preliminary efficacy study
And the patients?
A total of 92 patients have been enrolled, all of whom will receive 12-week regimens of Restoret.
What’s being measured?
The primary outcomes include the safety and mean change in best-corrected visual acuity (BCVA) from baseline to Week 12 in the study eye, determined by the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS).
Significance?
Through its activation of the Wnt pathway, Restoret has the potential to reduce leakage associated with the unmet medical needs for DME and AMD patients.