Luminate meets primary endpoint in phase 2 trial for dry AMD

A treatment candidate for dry age-related macular degeneration met its primary endpoint in a phase 2 study, with 48% of patients gaining at least eight letters of vision, according to a press release from Allegro Ophthalmics.

The prospective, randomized, double-masked, placebo-controlled trial evaluated safety and efficacy of Luminate (risuteganib) in intermediate dry AMD. Patients in the treatment arm were randomly assigned to receive one 1-mg Luminate (risuteganib) intravitreal injection at baseline and a second at week 16, while those in the sham arm received a sham injection at baseline and a 1-mg Luminate injection at week 16, the release said.

At week 28, 48% of patients in the treatment arm gained eight or more letters from baseline compared with 7% of patients in the sham arm at week 12 (P = .013).

“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,” Allegro CEO and President Vicken Karageozian, MD, said in the release. “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.”

Full study results will be presented at the American Society of Retina Specialists meeting in July.

A treatment candidate for dry age-related macular degeneration met its primary endpoint in a phase 2 study, with 48% of patients gaining at least eight letters of vision, according to a press release from Allegro Ophthalmics.

The prospective, randomized, double-masked, placebo-controlled trial evaluated safety and efficacy of Luminate (risuteganib) in intermediate dry AMD. Patients in the treatment arm were randomly assigned to receive one 1-mg Luminate (risuteganib) intravitreal injection at baseline and a second at week 16, while those in the sham arm received a sham injection at baseline and a 1-mg Luminate injection at week 16, the release said.

At week 28, 48% of patients in the treatment arm gained eight or more letters from baseline compared with 7% of patients in the sham arm at week 12 (P = .013).

“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,” Allegro CEO and President Vicken Karageozian, MD, said in the release. “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.”

Full study results will be presented at the American Society of Retina Specialists meeting in July.