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).
週四，Ocular Therapeutix Inc（納斯達克股票代碼：OCUL）公佈了HELIOS第一期研究的主要結果，該研究評估了沒有糖尿病黃斑水腫（DME）的中度重度至重度非增殖性糖尿病視網膜病變患者的Axpaxli與假對照的對比。
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組的13名患者中有6名（46.2％）的糖尿病視網膜病變嚴重程度量表（DRSS）在40周時出現了1或2步的改善，6名患者中有2名出現了兩步改善。
No patients in the control group showed 1- or 2-step improvement at the same time point.
對照組中沒有患者在同一時間點表現出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組中沒有任何患者的DRSS惡化。對照組的8名患者（12.5％）在40周時出現DRSS惡化的情況。
A single injection of AXPAXLI provided durable DRSS improvement up to 40 weeks.
單次注射 AXPAXLI 可持久改善 DRSS 長達 40 周。
No patients in either arm received rescue medication.
兩隻手臂的患者均未接受過救援藥物。
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.
該公司表示，HELIOS的結果支持了直接轉向Axpaxli對NPDR患者的3期研究的決定，尚待與美國食品藥品管理局的討論。
Axpaxli was generally well tolerated, with no inflammation observed, and there was no incidence of iritis, vitritis, or vasculitis.
Axpaxli的耐受性總體良好，未觀察到炎症，也沒有發生虹膜炎、玻璃體炎或血管炎。
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.
本月早些時候，Ocular Therapeutix公佈了開角型青光眼或高眼壓患者的Paxtrava（曲伏前列素腔內植入物或OTX-TIC）的2期數據。
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.
數據顯示，在六個月內，眼壓（IOP）持續降低，具有統計學意義（p
Price Action: OCUL shares are down 15.40% at $6.42 at the last check Thursday.
價格走勢：在週四的最後一次檢查中，OCUL股價下跌15.40％，至6.42美元。
Photo by Amanda Dalbjörn on Unsplash
阿曼達·達爾布約恩在 Unsplash 上拍攝的照片