EyeBiotech Limited has secured an additional $65 million in Series A financing to support the accelerated clinical development program for its lead candidate (Restoret) and retina pipeline.
Let’s start with a refresher.
The UK-based EyeBio was founded in 2021 as a privately-held ophthalmology biotechnology company focused on developing advanced therapies for eye diseases.
And this financing?
EyeBio’s successful extension and securing of financing brought its grand total to $130 million.
Its new investors include:
- Bain Capital Life Sciences
- Omega Funds
- Vertex Ventures HC
They join existing investors:
- SV Health Investors
- Jeito Capital
- Samsara BioCapital
- MRL Ventures Fund
Now this lead candidate.
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 learn mroe about importance of the Wnt pathway.
How does it work?
The antibody is delivered via intravitreal injections for retinal vascular diseases with leakage, including:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME)
- Familial exudative vitreoretinopathy (FEVR)
Restoret is designed to halt or reduce this vascular leakage by forcing the Wnt pathway to potentially restore and maintain the blood retinal barrier (BRB).
Any clinical data yet?
That’s ongoing—EyeBio began dosing the first patients in a phase 1b/2 trial (NCT05919693) in June 2023 that is assessing the safety and preliminary efficacy of Restoret in patients with DME and wet AMD.
Give me some details.
The Anti-permeability Mechanism and Age-Related Ocular Neovascularization Evaluation (AMARONE) multicenter, open-label trial enrolled 92 patients (ages 50+) in the two-part trial, which includes:
- Part 1
- Multiple-ascending dose (MAD) safety study
- Low, low-mid, mid-high, and high dose
- Multiple-ascending dose (MAD) safety study
- Part 2
- Dose-finding, single-masked comparative safety and preliminary efficacy study
- Naïve DME monotherapy: medium and high doses
- Naïve DME combination therapy: medium and high doses
- Experienced wet AMD combination therapy: medium and high doses
- Dose-finding, single-masked comparative safety and preliminary efficacy study
All patients are receiving 12-week regimens of Restoret.
What’s being measured?
The primary outcome is occurrence of adverse events (measured from baseline to Week 12 [3 months]).
The secondary outcome includes 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).
Any updates on it?
Yes! Per the company, enrollment has concluded for the MAD (part 1) portion of the study.
And according to Clinical Trials, the study is slated to conclude by the end of December 2024.
And the significance?
By activating the Wnt pathway, Restoret has the potential to reduce retinal vascular leakage associated with disease progression and visual loss in DME and AMD patients.