Eyestem has announced the successful completion of its Phase 1 clinical trial for Eyecyte-RPE, an investigational retinal pigment epithelium (RPE) cell therapy targeting geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The trial results have been submitted to the Central Drugs Standard Control Organization (CDSCO)—India’s regulatory authority for drugs and medical devices—for clearance to initiate Phase 2..

Eyestem 宣布其针对干性年龄相关性黄斑变性（干性 AMD）继发地理性萎缩（GA）的视网膜色素上皮（RPE）细胞疗法 Eyecyte-RPE 的 I 期临床试验已成功完成。试验结果已提交至印度药品和医疗设备监管机构——中央药品标准控制组织（CDSCO），以申请开展 II 期临床试验的批准。

Promising Results in Early-Stage Evaluation

早期评估结果令人鼓舞

The Phase 1/2a study was designed to assess both safety and efficacy of the therapy. According to the company, Eyecyte-RPE has demonstrated “promising outcomes in the initial phase,” with a strong safety profile and measurable visual gains.

1/2a期研究旨在评估该疗法的安全性和有效性。据公司称，Eyecyte-RPE在“初始阶段展现了良好的前景”，具有强大的安全性，并实现了可测量的视力提升。

“Our Phase 1/2a trial demonstrated an excellent safety profile with no serious adverse events while delivering clinically meaningful vision improvement—an average of 15.8 letters in the first six patients over six months,” stated Rajani Battu, PhD, Chief Medical Officer at Eyestem.

“我们的1/2a期试验展示了出色的安全性，无严重不良事件，同时带来了有临床意义的视力改善——前六名患者在六个月内的平均视力提高了15.8个字母，”Eyestem首席医学官Rajani Battu博士表示。

Dosing and Treatment Details

给药和治疗细节

The study involved nine patients, treated in three sequential, ascending dose-level (DL) cohorts:

该研究涉及九名患者，分为三个顺序递增的剂量水平（DL）队列进行治疗：

• DL1:

• DL1:

100,000 cells

十万细胞

• DL2:

• DL2:

200,000 cells

20万个细胞

• DL3:

• DL3:

300,000 cells

30万个细胞

Eyecyte-RPE is a suspension of human induced pluripotent stem cell (hiPSC)-derived retinal pigment epithelial (RPE) cells, designed to restore RPE function and slow progression in GA associated with dry AMD.

Eyecyte-RPE是一种由人诱导多能干细胞（hiPSC）衍生的视网膜色素上皮（RPE）细胞悬浮液，旨在恢复RPE功能并减缓与干性AMD相关的GA进展。

Pending regulatory approval, Eyestem is set to move forward with Phase 2 to further evaluate efficacy and expand the safety dataset in a broader patient population.

待监管部门批准后，Eyestem 将推进第二阶段，以进一步评估疗效并扩大在更广泛患者群体中的安全数据集。