Alcon drug meets primary endpoint of change in BCVA for wet AMD

RTH258 met its primary endpoint of mean change in best corrected visual acuity from baseline to week 12 in a phase 2 study of patients with neovascular age-related macular degeneration, Alcon announced in a press release.

RTH258, formerly known as ESBA 1008, is a novel, single-chain antibody fragment, which at a dose of 6 mg was compared with 2 mg Eylea (aflibercept, Regeneron) in a prospective, multicenter, randomized, double-masked study of 90 eyes.

The drug demonstrated “promising visual acuity gains that were non-inferior to aflibercept,” according to the release.

Both RTH258 and aflibercept were well-tolerated, with no adverse events, the release said. “Patients treated every 3 months with RTH258 also experienced a prolonged duration of action, potentially leading to a reduced treatment burden,” according to the release.

In December 2014, Alcon commenced two phase 3 clinical trials to gauge the safety and efficacy of RTH258 compared with aflibercept in patients with wet AMD. Alcon plans to enroll about 1,700 patients in more than 50 countries.

Patients in both phase 3 studies will receive RTH258 every 3 months. A bi-monthly dosing protocol will be undertaken for patients deemed unsuitable for quarterly dosing because of disease severity, the release said.

Patients will receive aflibercept under its approved label.