Successful Phase II trial for RTH 258 compared to aflibercept for age-related macular degeneration- Alcon

Alcon, presented positive results from its second Phase II clinical study of RTH 258 during the 38th Annual Macula Society Meeting in Scottsdale, Arizona. This study evaluated the efficacy and safety of the compound versus aflibercept in patients with neovascular (wet) age-related macular degeneration (AMD). RTH 258 (formerly known as ESBA 1008) is a novel, single-chain antibody fragment developed to treat wet AMD. The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept, with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH 258-treated patients. Patients treated every three months with RTH 258 also experienced a prolonged duration-of-action, potentially leading to a reduced treatment burden. A total of 90 patients diagnosed with wet AMD participated in the prospective, randomized, double-masked multicenter, two-arm study. The primary objective was to compare the efficacy of RTH 258 6mg versus aflibercept 2mg with the primary endpoint being the mean change in best corrected visual acuity (BCVA), from Baseline to Week 12. Secondary endpoints included the change assessment in BCVA and central subfield foveal thickness (CSFT) as measured by spectral domain optical coherence tomography (SD-OCT). Both RTH 258 and aflibercept were well tolerated and no new safety signal was reported during the study.

Comment;Alcon has already initiated a Phase III program to evaluate the efficacy and safety of RTH258 versus aflibercept in patients with wet AMD. Alcon expects to enroll approximately 1,700 patients in more than 50 countries.