Date: 2015-02-27
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at 38th Annual Macula Society Meeting in Scottsdale, Arizona
Company: Alcon (USA -TX), a Novartis subsidiary (Switzerland)
Product: RTH258
Action
mechanism:
- protein/antibody. RTH258 (formerly known as ESBA1008) is a novel, single-chain antibody fragment developed to treat wet AMD.
Disease: neovascular wet age-related macular degeneration (AMD)
Therapeutic
area: Ophtalmological diseases
Country:
Trial
details:
Latest
news:
- • On February 27, 2015, Alcon, the global leader in eye care, presented positive results from its second Phase II clinical study of RTH258 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). 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 RTH258-treated patients. Patients treated every three months with RTH258 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 RTH258 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 RTH258 and aflibercept were well tolerated and no new safety signal was reported during the study.
Is
general: Yes
