Allegro Ophthalmics' Luminate integrin peptide therapy has passed a phase 2 trial in diabetic macular edema (DME) patients by meeting its primary endpoint when used as a sequential treatment.
Dubbed DEL MAR stage 2, the phase 2b stage 2 clinical trial assessed the performance of Luminate as either a sequential therapy or in combination with anti-VEGF in 80 DME patients.
Allegro reported that Luminate as a sequential therapy at 1.0mg dosage showed visual acuity gains equivalent at all time points to bevacizumab monotherapy.
Luminate also demonstrated 12-week durability post completion of three loading doses like in a previous trial named as DEL MAR Stage 1 trial where the drug met both primary and secondary endpoints as a monotherapy for DME.
In the DEL MAR Phase 2 Stage 2 study, the primary endpoint was defined as non-inferiority to bevacizumab in mean change in best-corrected visual acuity (BCVA) at 20 weeks. This applied to the usage of Luminate as a sequential therapy which is with a single bevacizumab pre-treatment or when combined with bevacizumab.
Allegro Ophthalmics president and chief medical officer Vicken Karageozian said: “Positive results in DEL MAR Stages 1 and 2 continue to confirm Luminate’s safety and efficacy, and its 12-week durability in patients with DME.
“What’s more, about 60 percent of those treated in the DEL MAR trial had been chronic anti-VEGF users, which suggests that Luminate, with its unique mechanism of action, may successfully treat more patients, including those who don’t respond to anti-VEGF.”
The DEL MAR Stage 2 trial also proved that Luminate was well-tolerated with no data suggesting any drug toxicity or intraocular inflammation.
Also, Allegro says that the safety results of the phase 2 trial are on par with previous studies on Luminate on human subjects where no significant inflammation and no evidence of retinal tears or detachments were observed.