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Novel dry AMD treatment found safe, tolerable in phase 1b study
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FORT LAUDERDALE, Fla. — A visual cycle modulator under development as an oral dry age-related macular degeneration treatment was found to be safe and well-tolerated in a 14-day daily dose, according to researchers here.
Ryo Kubota, MD, PhD, and colleagues found that ocular adverse events occurred in 66.7% of study subjects who received ACU-4429 (Acucela), but all adverse events were mild and resolved after the completion of the study, according to a poster presentation at the Association for Research in Vision and Ophthalmology meeting. No systemic adverse events were reported.
“This is very interesting because this could be the only orally available molecule for geographic atrophy,” Dr. Kubota told Ocular Surgery News in an interview.
Dr. Kubota also said that a phase 2a clinical trial is currently under way in the United States at 13 sites in eight states.
According to company literature, visual cycle modulators reduce “the metabolic load on rod and cone cell deterioration.” Rod cells, which make up 90% of photoreceptor cells, are damaged by light and other factors over time, and cone cells are dependent on rod cells as well.
In the phase 1b study, 30 subjects received doses of ACU-4429 ranging from 5 mg to 40 mg, and 10 subjects received placebo.
- Disclosure: The study authors are employees of Acucela.