Allegro Ophthalmics has started enrolment of patients in a Phase II clinical trial, which will assess the safety and efficacy of its Luminate (ALG-1001) for non-proliferative diabetic retinopathy (DR).
Luminate is a first-in-class integrin peptide therapy that treats vitreoretinal diseases by targeting integrin receptors involved in cell signalling and regulation and can be used in the construction of new and aberrant blood vessels.
The trial has been designed to assess whether Luminate will induce posterior vitreous detachment (PVD) in patients with non-proliferative DR.
Allegro Ophthalmics chief technical officer Dr Vicken Karageozian said: "Given the lack of practical treatment options currently available for PVD induction in non-proliferative DR, there is a significant need for novel, non-surgical treatments that optimise long-term clinical outcomes."
The trial is a randomised, double-masked, placebo-controlled and multi-centre dose-ranging study that will assess the safety and efficacy of intravitreal injections of Luminate in patients with non-proliferative DR.
In the trial, Allegro will enrol around 100 subjects who will be randomised to one of four treatment groups, including three Luminate groups 1.0mg, 2.0mg, 3.0mg and a placebo group.
According to Allegro, Luminate has been demonstrated in clinical studies to effectively regress and inhibit new blood vessel formation by utilising two mechanisms of action, including anti-angiogenesis and vitreolysis.
Luminate is an investigational drug not approved by the FDA for commercial sale in the US, and is currently in Phase II clinical trials for multiple indications, including diabetic macular edema (DME) and vitreomacular traction (VMT).
The company holds the commercial rights of Luminate in all territories outside of Japan, Korea and China.
Image: Fundus photo showing scatter laser surgery for diabetic retinopathy. Photo: courtesy of National Eye Institute, National Institutes of Health.