Phase II clinical trial data from a study of integrin peptide therapy (referenced as “ALG-1001” or “Luminate”), conducted in 106 patients with vitreomacular traction (VMT) or vitreomacular adhesion (VMA), has reported that 3.2 mg of the intravitreal injection met the primary endpoint of a greater proportion of patients achieving release of VMT or VMA by day 90, versus placebo (65% vs. 9.7%, p=0.0129). However, the control group used was a placebo cohort treated only with a balanced salt solution. Consequently, comparison to other approved treatments would be required to assess the real-world value of the potential treatment. The study, a Phase II, prospective, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of the new treatment, sponsored by Allegro Ophthalmics LLC (based in San Juan Capistrano, California, USA), also reported no drug toxicity or intraocular inflammation with the repeated intravitreal injections.
Integrins are a family of proteins that facilitate cell-to-cell attachment as well as attachment to the extracellular matrix. The company behind the ALG-1001 experimental drug claims it the therapy may provide a first in class integrin peptide treatment with potential use in a number of ophthalmic indications. Previous animal studies did not show toxicity under light or electron microscopy but did demonstrate vitreous liquefaction and the induction of posterior vitreous detachment. In previous clinical studies among other indications, Allegro reported that ALG-1001 showed three to five lines of improvement in best corrected visual acuity (BCVA) and showed corresponding improvements in OCT central macular thickness (CMT). In addition, the company stated that non-responders did not experience any material loss in BCVA or increase in CMT during the course of clinical investigation. In addition to its anti-angiogenic effects, the sponsor claims that ALG-1001 targets key integrin receptor sites at the vitreoretinal interface to release the cellular adhesion between the vitreous and the retina, leading to separation at the interface and resolution of VMT. According to Allegro, the two mechanisms of action (vitreolysis and anti-angiogenesis), may be used to address multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR). The company maintains commercial rights to the experimental drug in all territories other than Japan, Korea and China.
Commenting on the clinical results, Michael Tolentino, M.D., Associate Professor Ophthalmology at the University of Central Florida, and a clinical investigator on the study stated, “These findings appear to be very promising. It is a very positive outcome to have 65 percent of eyes treated with the 3.2 mg dose of Luminate achieve VMT/VMA release by Day 90. These statistically significant findings, as assessed by the Duke Reading Center, coupled with the fact that Luminate has been shown to be well-tolerated, makes me optimistic that Luminate will provide meaningful clinical benefit to patients with VMT or VMA.” According to Vicken Karageozian, M.D., Chief Technical Officer, Allegro Ophthalmics, “These positive results continue to affirm the safety and efficacy of Luminate. The vitreolytic properties confirmed in this study and the anti-angiogenic properties demonstrated in earlier DME and neovascular AMD studies continue to validate our clinical development approach of advancing Luminate across multiple vitreoretinal indications.”