Top-line Phase IIb results showed Allegro Ophthalmics’ first-in-class integrin peptide inhibitor, Luminate, achieved its primary and secondary endpoints for efficacy and safety in treatment of diabetic macular edema (DME), President and Chief Medical Officer Vicken Karageozian, MD, said at the Posterior Segment Company Showcase at OIS@AAO 2016.
Luminate has two different mechanisms of action with the potential to treat four diseases: anti-angiogenesis for DME and wet age-related macular degeneration (AMD), and vitreolysis to treat posterior vitreous detachment (PVD) and vitreomacular traction (VMT). Dr. Karageozian noted that approximately 400 patients have been treated with Luminate to date without any drug-related serious adverse events.
The DEL MAR DME Phase IIb (stage 1) monotherapy trial Dr. Karageozian reported on showed Luminate was equivalent when compared with Avastin (bevacizumab, Genentech) when each were used in monotherapy. The trial involved 136 subjects who received either three monthly injections of Luminate (1, 2, and 3 mg) or six monthly injections of Avastin. At week 20, 12 weeks after the last Luminate treatment, the Avastin group showed a 7-letter gain in best-corrected visual acuity, while the Luminate arm had a 5.2-letter gain, which was within the non-inferiority margin.
The secondary endpoint was improvement in central retinal thickness (CRT) as measured with optical coherence tomography (OCT). At 20 weeks – four weeks post-Avastin and 12 weeks post-Luminate – the Avastin arm had a 104-μm reduction in CRT versus a 77-μm reduction for Luminate, Dr. Karageozian said. “You only load with three injections of Luminate and yet the drug keeps going at eight weeks off treatment, and 12 weeks off treatment is when it hits its groove,” he continued.
The trial also reported no drug-related serious adverse events in the Luminate arm, he said.
Going forward, Allegro plans to investigate how Luminate works as a combination and adjunctive therapy. Besides the DEL MAR stage 1 trial, Allegro has Phase II US studies in DME (stage 2) and PVD due for readout in 2017, and is anticipating starting a Phase III DME trial in late 2017 using prefilled, disposable syringes, Dr. Karageozian said.
Vicken Karageozian, MD
Vicken Karageozian, MD, is president and chief medical officer of Allegro Ophthalmics.