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A new possible therapy for vitreomacular adhesion and vitreomacular traction had positive results in a phase II trial.
Take-home message: A new possible therapy for vitreomacular adhesion and vitreomacular traction had positive results in a phase II trial.
By Vanessa Caceres; Reviewed by Michael Tolentino, MD
Orlando-A phase II clinical trial with the drug, ALG-1001 (Luminate, Allegro Ophthalmics), for vitreomacular traction (VMT) or vitreomacular adhesion (VMA) met its primary endpoint, according to study data.
The trial evaluated the safety and efficacy of ALG-1001 intravitreal injections in 106 study subjects. The trial was prospective, double-masked, and placebo-controlled.
The study divided 106 study subjects into three ALG-1001 groups (2.0 mg, 2.5 mg, and 3.2 mg) and a balanced salt solution placebo group. Sixty-five percent of eyes treated with the 3.2 mg dose of ALG-1001 had release of VMT or VMA by day 90, which was the end of the study, compared with 9.7% in the placebo control group.
No drug toxicity or intraocular inflammation occurred.
“These safety results are consistent with previously conducted [ALG-1001] studies on human subjects where there were no rod or cone photoreceptor dysfunction on full-field electroretinogram testing, no afferent pupillary defects, and no evidence of retinal tears or detachments,” according to a prepared statement.
The drug is a new kind of therapy to treat vitreoretinal diseases.
“It targets integrins, cell receptors that serve as bridges between cells, regulating their interactions with each other and with the extracellular matrix,” said Michael Tolentino, MD, associate professor of ophthalmology, University of Central Florida, Orlando, and director of research, Center for Retina and Macular Disease, Winter Haven, FL. Dr. Tolentino is a clinical investigator for the phase II VMT study.
The drug is an RGD-class oligopeptide that binds to multiple integrin receptor sites and affects multiple pathways.
“This and its dual mechanisms of action-anti-angiogenesis and vitreolysis-make it effective across a number of different vitreoretinal conditions,” he said.
In other specialties, integrin-targeting drugs are used to treat multiple sclerosis, Crohn’s disease, ulcerative colitis, and coronary disease, Dr. Tolentino said.
Lifitegrast (Shire Pharmaceuticals), a new therapy under review by the FDA, also uses an integrin-targeting approach.
The most widely used treatment for symptomatic VMA and VMT is pars plana vitrectomy, Dr. Tolentino said, although ocriplasmin (Jetrea, ThromboGenics) has been approved for this indication.
The “ideal” patient for ALG-1001 is someone with symptomatic VMA or VMT who is contemplating vitrectomy but does not want to undergo a difficult surgical procedure, Dr. Tolentino said. There are no contraindications right now for its use.
Although Allegro Ophthalmics had positive results from the phase II Luminate trial for VMA or VMT, the company noted it is currently focused on trials with the drug for other ocular conditions to further investigate the drug’s dual mechanisms of action (anti-angiogenesis and vitreolysis). This includes phase II study in patients with vision loss secondary to centrally involved diabetic macular edema and posterior vitreous induction in patients with nonproliferative diabetic retinopathy.
The company also noted it will begin a phase II study to test ALG-1001 to treat wet age-related macular degeneration, refractory diabetic macular edema, and adjunctive to pars plana vitrectomy.
“Allegro will make further determinations on the next steps for its VMT program after the full analysis of the data and meeting with the FDA,” Dr. Tolentino said.
Michael Tolentino, MD
Dr. Tolentino is a clinical investigator for the phase II VMT study.