Ocular Therapeutix Highlights Early Data From Diabetes-Related Eye Disorder
Ocular Therapeutix Highlights Early Data From Diabetes-Related Eye Disorder
On Thursday, Ocular Therapeutix Inc (NASDAQ:OCUL) announced topline results from the Phase 1 HELIOS study evaluating Axpaxli versus sham control in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema (DME).
周四，Ocular Therapeutix Inc（纳斯达克股票代码：OCUL）公布了HELIOS第一期研究的主要结果，该研究评估了没有糖尿病黄斑水肿（DME）的中度重度至重度非增殖性糖尿病视网膜病变患者的Axpaxli与假对照的对比。
6 of 13 (46.2%) patients in the Axpaxli group experienced a 1 or 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks, with 2 of the 6 having a 2-step improvement.
Axpaxli组的13名患者中有6名（46.2％）的糖尿病视网膜病变严重程度量表（DRSS）在40周时出现了1或2步的改善，6名患者中有2名出现了两步改善。
No patients in the control group showed 1- or 2-step improvement at the same time point.
对照组中没有患者在同一时间点表现出1步或2步的改善。
No patients in the Axpaxli group experienced any worsening in DRSS. 1 of 8 (12.5%) in the control group experienced worsening in the DRSS at 40 weeks.
Axpaxli组中没有任何患者的DRSS恶化。对照组的8名患者（12.5％）在40周时出现DRSS恶化的情况。
A single injection of AXPAXLI provided durable DRSS improvement up to 40 weeks.
单次注射 AXPAXLI 可持久改善 DRSS 长达 40 周。
No patients in either arm received rescue medication.
两只手臂的患者均未接受过救援药物。
The company says the HELIOS results support the decision to move directly to a Phase 3 study with Axpaxli in patients with NPDR, pending discussions with the FDA.
该公司表示，HELIOS的结果支持了直接转向Axpaxli对NPDR患者的3期研究的决定，尚待与美国食品药品管理局的讨论。
Axpaxli was generally well tolerated, with no inflammation observed, and there was no incidence of iritis, vitritis, or vasculitis.
Axpaxli的耐受性总体良好，未观察到炎症，也没有发生虹膜炎、玻璃体炎或血管炎。
Earlier this month, Ocular Therapeutix revealed Phase 2 data for Paxtrava (travoprost intracameral implant or OTX-TIC) in patients with open-angle glaucoma or ocular hypertension.
本月早些时候，Ocular Therapeutix公布了开角型青光眼或高眼压患者的Paxtrava（曲伏前列素腔内植入物或OTX-TIC）的2期数据。
The data highlight consistent and sustained reductions in Intraocular Pressure (IOP), statistically significant (p<0.0001) through six months, with clinically meaningful reductions of 24-30% achieved with a single Paxtrava implant.
数据显示，在六个月内，眼压（IOP）持续降低，具有统计学意义（p
Price Action: OCUL shares are down 15.40% at $6.42 at the last check Thursday.
价格走势：在周四的最后一次检查中，OCUL股价下跌15.40％，至6.42美元。
Photo by Amanda Dalbjörn on Unsplash
阿曼达·达尔布约恩在 Unsplash 上拍摄的照片