Allegro Ophthalmics has announced that the DEL MAR Phase 2b clinical trial analysing Luminate (ALG-1001) in 136 patients with diabetic macular edema (DME) met its primary and secondary endpoints.
This demonstrates the visual acuity gains and reduction in central macular thickness (CMT) that were equivalent to bevacizumab monotherapy.
The primary endpoint of the DEL MAR Phase 2 study was non-inferiority to bevacizumab in mean change in best-corrected visual acuity (BCVA) at 20 weeks.
The results were achieved following three injections and 12 weeks off treatment, compared to six injections given every four weeks with bevacizumab.
Data indicated the mean gain in BCVA was 5.2 letters for patients in the 1mg Luminate arm 12 weeks off Luminate loading, compared to 7.0 letters for patients in the 1.25mg bevacizumab arm dosed every four weeks.
The secondary endpoint was non-inferiority to bevacizumab in mean change within CMT as measured by optical coherence tomography (OCT).
At week 20, patients in the 1mg Luminate arm indicated a mean reduction of 77 micrometres (µm) 12 weeks off Luminate loading versus 104µm in the 1.25mg bevacizumab arm dosed every four weeks.
This was a controlled, double-masked, multi-centre, dose-ranging trial, which included three Luminate arms of 1mg, 2mg, and 3mg, treated with three monthly Luminate loading injections followed by 12 weeks off treatment, and a 1.25mg bevacizumab arm of six monthly injections.
The study found that Luminate was well-tolerated, with no drug toxicity or intraocular inflammation.
The firm stated that the safety results are in line with previously conducted Luminate studies on patients where there were no reports of significant inflammation, no afferent pupillary defects, and no evidence of retinal tears or detachments.
Allegro Ophthalmics chief medical officer and president Vicken Karageozian said: “These positive results continue to affirm the safety and efficacy of Luminate, and confirm its 12-week monotherapy durability.
“Allegro is deeply committed to developing novel therapies that address vitreoretinal patients’ unmet needs with new mechanisms of action that have the potential to help a larger population.”