Improvement in BCVA seen in patients with dry AMD after risuteganib treatment
Patients with dry age-related macular degeneration experienced improvements in best corrected visual acuity after treatment with risuteganib, according to a phase 2a study.
Study author David S. Boyer, MD, told Healio/OSN that unmet needs remain in the treatment of dry AMD.
“The treatment of neovascular age-related macular degeneration has undergone a renaissance in the last 2 decades,” he said. “Unfortunately, there remains a lack of treatment for dry macular degeneration, though numerous trials are investigating the treatment of patients with dry macular degeneration associated with geographic atrophy.”
Safety and efficacy were evaluated in 45 patients with nonexudative AMD who were randomly assigned to undergo treatment with 1 mg risuteganib (Allegro Ophthalmics) or sham injection. At week 16, patients in the risuteganib group received a second dose, while patients in the sham group crossed over to receive 1 mg risuteganib before evaluation at week 28.
The primary endpoint of the study was the proportion of patients with a BCVA gain of eight ETDRS letters or more from baseline to week 28 in the risuteganib group vs. baseline to week 12 in the sham group.
Thirty-nine patients completed the study, 25 in the risuteganib group and 14 in the sham group. Mean BCVA at baseline was 64.4 letters in the risuteganib group and 67.1 letters in the sham group.
At week 28, 48% of patients in the risuteganib group achieved the primary endpoint compared with 7% in the sham group at week 12 (P = .013). Additionally, 20% of patient in the risuteganib group gained 15 or more letters at week 28, while none of the patients in the sham group achieved that level of visual acuity gain at week 12.
No drug-related serious adverse events were reported during the study.
“The … study showed that intravitreal administration of risuteganib (an integrin) was safe and able to improve vision in patients with dry macular degeneration without geographic atrophy,” Boyer said. “This is the first study that demonstrated a significant improvement in vision in this previously untreatable condition. The phase 2 results give us valuable information that will guide us in the phase 3 study.”