Restoret, EyeBio’s lead asset in its multi-specific agonist pipeline, is a tri-specific Wnt agonist antibody designed to address urgent unmet medical need in patients with back-of-the-eye diseases, including diabetic macular edema (DME) and age-related macular degeneration (AMD).
For patients living with DME and AMD, the burden of disease is significant and the cost of losing vision is high, it said.
Restoret, it continued, will enable the clinical translation of the Wnt pathway for the first time in the eye. Because patient need is only partially addressed by current anti-VEGF therapies, the company maintains there is a compelling opportunity for a non-VEGF-targeted mechanism of action like that of Restoret.
Since the discovery that Wnt genes code for proteins that drive normal development and maintenance of the blood-retinal barrier, the Wnt pathway has been a focus of many top research institutes, said EyeBio.
Published research has shown that Wnt signaling in the retina plays a central role in the maintenance of vascular integrity, and defects in Wnt signaling cause retinal vascular leakage. A mimetic of norrin, which is the natural Wnt ligand in the eye, Restoret has demonstrated efficacy in preclinical ophthalmic models, including validation in genetic models, it added.
“Our goal is to build a broad and diverse pipeline of therapies for the eye. There are multibillion dollar commercial opportunities and urgent unmet medical needs in relation to Wet AMD, Dry AMD, diabetic retinopathy, dry eye, and glaucoma.
“I see the future of ophthalmology as being very similar to oncology where we are seeing combination therapies, cocktail treatment. While the anti-VEGF drugs were a big step forward, it is going to be the combination of another novel mechanism of action with an anti-VEGF drug that will give us synergistic effects. That is a major area [of ocular drug development] and one that we are very excited about,” EyeBio CEO, David Guyer, told us in February 2022.
There has been a transformation in the past few years in terms of ocular drug development, he noted then. “We are seeing very exciting research at all levels, both academically and in industry.”
EyeBio said it would file for clinical trial authorizations to facilitate a global Phase 1b/2 clinical trial of Restoret in the second quarter of 2023.
The company has also in-licensed a second bispecific agonist antibody asset for the treatment of retinal diseases, with a separate and complementary mechanism of action to Restoret.
And it has been expanding its leadership team: Dr Anthony Adamis has been named EyeBio’s chief scientific officer. He co-founded EyeBio in 2021 and Eyetech in 2002 with Dr Guyer. He alos led the development and FDA approval of Vabysmo at Genentech.
Loni Da Silva as EyeBio's new chief regulatory officer brings extensive ophthalmology regulatory leadership experience and led the first retinal drug - Macugen - approval, while Frances Betts has been appointed as the company's head of clinical operations, globally. She has recruited thousands of patients into more than 20 ophthalmology clinical trials, noted EyeBio.
Mike Davies has been appointed its chemistry, manufacturing, and control (CMC) lead and Eric Ng its senior vice president, biology.