Chugai's Vabysmo Demonstrates Sustained Vision Improvements in 48-Week Angioid Streaks Trial
核心洞察
Chugai Pharmaceutical presented 48-week data from the NIHONBASHI Phase III study showing Vabysmo maintained vision improvements in Japanese patients with angioid streaks (搜索) associated with neovascularization.
The bispecific antibody demonstrated a mean vision improvement of +7.3 letters and reduced central subfield thickness by -104 μm at 48 weeks, sustaining benefits observed at 12 weeks.
Vabysmo represents the first approved drug in Japan for choroidal neovascularization (搜索) associated with angioid streaks (搜索), addressing a significant unmet medical need in this rare retinal condition.
Chugai Pharmaceutical Co., Ltd. announced that 48-week data from the Phase III NIHONBASHI study evaluating Vabysmo (faricimab) in angioid streaks (搜索) associated with neovascularization were presented at the 64th Annual Meeting of the Japanese Retina and Vitreous Society. The results demonstrated sustained vision improvements and reduction in retinal edema (搜索), marking a significant advancement for patients with this rare retinal condition.
Sustained Clinical Benefits at 48 Weeks
The extended follow-up data showed that vision improvements achieved at 12 weeks were maintained through 48 weeks of treatment. Patients receiving Vabysmo demonstrated a mean vision improvement of +7.3 letters (90% confidence interval: 4.5 to 10.0 letters) from baseline at Week 48, as measured by best-corrected visual acuity (BCVA) score.
The study also tracked retinal fluid reduction, with the mean change in central subfield thickness from baseline reaching -104 μm (90% confidence interval: -123 to -85 μm) at Week 48. This reduction in retinal swelling is clinically significant, as edema caused by excess fluid in the retina is associated with visual distortion and foggy vision.
"We are very pleased that the 48-week data from the NIHONBASHI study in Japanese patients demonstrated sustained vision improvements and reduction in retinal edema (搜索)," said Dr. Osamu Okuda, Chugai's President and CEO. "We will continue to deliver this value to patients and contribute to long-term preservation of vision through continuing to strengthen the data and provide information on the appropriate use of this treatment."
First-in-Class Treatment for Rare Condition
Vabysmo represents the first drug approved in Japan for choroidal neovascularization (搜索) associated with angioid streaks (搜索). The treatment addresses a significant unmet medical need, as conventional treatments such as surgery and laser therapy are not sufficiently effective for patients with neovascularization, who typically have a poor prognosis.
The safety profile observed in the NIHONBASHI study was consistent with previous studies of Vabysmo, with the drug being generally well tolerated throughout the 48-week treatment period.
Study Design and Patient Population
The NIHONBASHI study was a multicenter, open-label, single-arm Phase III study conducted in Japan, enrolling 24 patients with angioid streaks (搜索) associated with neovascularization. Patients received Vabysmo every 4 weeks for the first three doses, followed by disease activity assessments at 4-week intervals with treatment administered as needed.
The primary endpoint was change in BCVA from baseline at week 12, while secondary endpoints included changes in central subfield thickness and the proportion of individuals with resolution of intraretinal fluid and subretinal fluid through 48 weeks.
Dual-Pathway Mechanism of Action
Vabysmo is the first bispecific antibody approved for ocular use, targeting and inhibiting two signaling pathways linked to vision-threatening retinal conditions. The drug neutralizes both angiopoietin-2 (搜索) (Ang-2) and vascular endothelial growth factor-A (VEGF-A (搜索)), which contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form, and increasing inflammation.
Disease Background and Unmet Need
Angioid streaks (搜索) is characterized by cracks in parts of the retina, causing discoloration of the fundus. While often asymptomatic, the condition becomes problematic when choroidal neovascularization (搜索) extends to the macula region, causing decreased or distorted vision. The number of patients with angioid streaks in Japan is unknown, but approximately 300 patients have pseudoxanthoma elasticum (搜索), a designated intractable disease known to be associated with angioid streaks in approximately half of patients.
Vabysmo is currently approved in over 100 countries worldwide for various retinal conditions, including neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion.