SAN FRANCISCO — Luminate showed potential for the treatment of intermediate dry age-related macular degeneration, according to study results presented at Retina Subspecialty Day prior to the American Academy of Ophthalmology annual meeting.
“The pathogenesis of dry AMD is not well established; however, there’s toxicity of stress that causes photoreceptor and RPE-degeneration and incites inflammation – all these lead to a potential loss of function,” David S. Boyer, MD, of the Retina-Vitreous Associates Medical Group, California, said during the presentation. “This drug will block the toxicity of stress, the photoreceptor- and RPE-degeneration and reduce inflammation.”
Boyer and colleagues examined the safety and efficacy of Luminate (risuteganib, Allegro Ophthalmics) for dry AMD in a prospective, double-masked, placebo-controlled, multicenter phase 2 study. The researchers randomly assigned eyes with best corrected visual acuity (BCVA) between 20/40 and 20/200 to receive 1-mg risuteganib or sham at baseline. The risuteganib group received a second dose at week 16, and the sham group could cross over to receive one dose of 1-mg risuteganib.
The researchers measured change in BCVA of the risuteganib group from baseline to week 28 compared with sham from baseline to week 12 (primary endpoint).
Forty-five patients were enrolled in the study (mean age = 76.2 years; 76% women; mean baseline BCVA = 61 letters), according to the abstract.
Boyer reported there was much better vision improvement with risuteganib vs. sham. Compared with sham, more patients who received risuteganib gained 8 or more letters (48% vs. 7%; P = .013).
Additionally, from baseline, the number of patients who gained 10 or more letters was 7.1% with sham vs. 32% with risuteganib and 0% vs. 20%, respectively, gained 15 letters or more, according to the presentation. Further, Boyer reported risuteganib showed good safety profile; no systemic or ocular serious adverse events occurred.
“In conclusion, risuteganib is a small synthetic peptide that regulates select integrin function that, in phase 2, met its primary endpoint,” Boyer said. “We’ve learned that this drug may last a long time. A larger trial is underway.” – by Savannah Demko
Reference: Jaffe GJ, et al. Primary results from phase 2 study of risuteganib in intermediate dry AMD. Presented at: American Academy of Ophthalmology annual meeting; Oct. 11-15, 2019; San Francisco.
Disclosure: Boyer reports consulting for and having equity for Allegro.