原始来源记录
该新闻稿披露了正在进行的 OCU410 2 期 ArMaDa 试验的 12 个月解剖学疗效具有统计学意义,显示病灶生长较对照组减少 46%。在 1/2 期共 60 名患者中未观察到与药物相关的严重不良事件。公司重申计划于 2026 年启动 3 期试验,并于 2028 年提交 BLA 申请。
EX-99.1 2 tm263269d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Ocugen Announces Positive Preliminary Phase 2 Data from OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration · Phase 2 (~50% of patients evaluated to date at 12 months) shows 46% lesion growth reduction vs. control · There are no OCU410-related serious adverse events reported across the Phase 1 and Phase 2 clinical trials to date MALVERN, Pa., January 15, 2026 (Globe Newswire) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced positive preliminary 12-month data (~50% of patients evaluated to date) from the Phase 2 ArMaDa clinical trial evaluating OCU410 (AAV5-RORA), its novel modifier