David S. Boyer
SAN FRANCISCO — More patients with dry age-related macular degeneration treated with risuteganib, a small synthetic peptide that regulates select integrin functions involved in the pathogenesis of the disease, experienced an eight or more letter gain in best corrected visual acuity 12 weeks after treatment compared with a sham group, according to a speaker here.
“In phase 2, it hit its primary endpoint with 48% of patients gaining eight letters vs. 7% of a sham group,” David S. Boyer, MD, said at Retina Subspecialty Day at the American Academy of Ophthalmology annual meeting.
The study evaluated the safety and efficacy of 1 mg risuteganib (Allegro Ophthalmics) intravitreal injection in patients with intermediate nonexudative AMD compared with a sham cohort. The primary endpoint of the study was the percentage of patients in either cohort with an eight letter or greater gain in BCVA from baseline, Boyer said.
Twenty-five patients were in the risuteganib cohort and 14 in the sham/crossover cohort. Patients received either a risuteganib injection or a sham injection at baseline and then a risuteganib injection at 16 weeks.
At 28 weeks, 48% of risuteganib patients gained eight or more letters of BCVA compared with 7.1% of patients in the sham cohort, a statistically significant difference (P = .013). Additionally, 32% of risuteganib patients gained 10 or more BCVA letters compared with 7.1% of sham patients, and 20% of risuteganib patients gained 15 or more letters compared with none of the sham patients, Boyer said.
“It had a good safety profile, and over 1,200 injections have been given outside of the study for this drug. A larger study trial is also underway,” he said. – by Robert Linnehan
Boyer DS. Primary results from phase 2 study of risuteganib in intermediate dry AMD. Presented at: American Academy of Ophthalmology annual meeting; October 11-15, 2019; San Francisco.
Disclosure: Boyer reports he is a consultant to Allegro and Adverum Biotechnologies.