典晶生物宣布其在美国进行的首个EB-105 临床试验圆满结束

LOTUS is a multicenter study being conducted in the United States. Part 1 of the study was a single ascending dose study in patients with DME. Part 1 was conducted at five centers in the United States. In addition to participation by Dr. Sheth were the following leading retinal surgeon investigators: Ashkan Abbey, MD, Dallas, TX; David Almeida, MD, Erie, PA; Carl Awh, MD, Nashville, TN; and Charles Wyckoff, MD, Houston, TX. The LOTUS Part 2 study will be conducted with multiple ascending doses (≥ 3 monthly IVT  injections) in a similar DME population evaluating the same three dose   levels as assessed in Part 1 and will be conducted at up to 10 sites in the United States. The primary objectives of Part 2 will be safety, tolerability and pharmacodynamics and to potentially select a single dose level for Phase 2/3 studies in the future.  The study is anticipated to begin enrollment in Q3 2025.