Novel Integrin Inhibitor Meets End Point in Dry Age-Related Macular Degeneration Study

This article is part of MPR’s coverage of the American Academy of Ophthalmology 2019 Meeting, taking place in San Francisco, CA. Our staff will report on medical research related to eye disorders, conducted by experts in the field. Check back regularly for more news from AAO 2019.

SAN FRANCISCO – Intravitreal risuteganib demonstrated statistical significance compared to sham injection in patients with intermediate nonexudative age-related macular degeneration (dry AMD), according to study results presented at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting, held October 12-15, 2019 in San Francisco, California.

The phase 2 trial is a prospective, randomized, double-masked, placebo-controlled, multicenter study evaluating the efficacy and safety of risuteganib in patients with intermediate dry AMD. Patients were randomized to receive either intravitreal risuteganib 1mg (n=25) or sham injection (n=15) at baseline. At Week 16, patients in the risuteganib arm received a second dose of risuteganib 1mg while patients in the sham arm crossed over and received a single dose of risuteganib 1mg. The primary efficacy end point was the percentage of patients with ≥8 letters best corrected visual acuity (BCVA) gain from baseline to Week 28 in the risuteganib group vs from baseline to Week 12 in the sham group. 

Primary results showed that 2 injections of risuteganib 1mg achieved the primary end point with 48% of patients at Week 28 gaining ≥8 letters from baseline vs 7% of patients at Week 12 in the sham arm (P =.013). Risuteganib was found to have a tolerable safety profile with no serious drug-related adverse events reported. The study is approaching completion and investigators are planning to release full data analysis in the upcoming weeks. 

“It is very encouraging to see such robust visual acuity gains in patients with dry AMD, a sight-threatening disease for which there is currently no available treatment.  It is also exciting to see that these initial clinical findings in dry AMD confirm our extensive preclinical findings and earlier clinical studies that suggested risuteganib could restore visual function,” Vicken Karageozian, MD, President and CEO of Allegro Ophthalmics stated.

Risuteganib (ALG-1001) is a novel integrin inhibitor in clinical development by Allegro Ophthalmics with a proposed brand name of Luminate. If approved, it will be the first integrin inhibitor for the treatment of dry AMD.

Reference

Jaffe GJ, Kaiser PK, Kuppermann BD, et al. Primary results from phase 2 study of risuteganib in intermediate dry AMD. Presented at: The American Academy of Ophthalmology (AAO) 2019 Annual Meeting; October 12-15, 2019; San Francisco, California. Abstract PO435.