Tyrogenex initiates phase 2 study of X-82 for wet AMD
Tyrogenex has initiated a phase 2 study of X-82 for the treatment of wet age-related macular degeneration, according to a press release.
The treatment is a dual inhibitor of VEGF and PDGF that is administered orally.
The randomized, double-masked, placebo-controlled, dose-finding APEX study will evaluate the safety and efficacy of X-82 in 132 subjects in the prevention of vision loss due to wet AMD.
The primary endpoint consists of mean change in visual acuity score throughout a 52-week follow-up and the reduction of the number of Eylea (aflibercept, Regeneron) injections needed during the study.
X-82 maintained or improved vision in all subjects during a 6-month phase 1 study. There were no dose-limiting toxicities, and rescue injections were not needed for most subjects.
“Current treatments for wet AMD require injections into the eye, and we believe an oral treatment, like X-82, may make a significant difference for patients who are battling blindness and for whom regular visits to the physician’s office are challenging,” Michael D. Webb, president and CEO of Tyrogenex, said in the release.