相关临床试验
13
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2007
已完成
12
92.3%
招募中
1
7.7%
暂无批准数据
- Hengrui Pharma and Novaliq announced NMPA approval of Heng Yi (0.1% cyclosporine ophthalmic solution) on June 23, 2026, for the treatment of dry eye disease. - Heng Yi is the first and only water-free cyclosporine ophthalmic solution in China, based on Novaliq's EyeSol platform, and the second EyeSol-based product approved in the country. - The Phase III SHR8028-301 bridging trial met its primary endpoint, demonstrating a statistically significant reduction in total corneal fluorescein staining score at Day 29 (treatment: −4.8 vs control: −3.0; P<0.0001). - The approval positions Hengrui to address both aqueous-deficient and evaporative dry eye subtypes through a combined portfolio with previously approved Heng Qin.
- Eyenovia has entered into a non-binding letter of intent with Betaliq to create a new publicly-listed eye care company valued at approximately $92 million, with Betaliq shareholders owning 83.7% of the combined entity. - The merger would combine Betaliq's EyeSol® water-free drug delivery technology for glaucoma with Eyenovia's Optejet® device platform, potentially creating a revolutionary approach to topical eye medication administration. - If completed, the combined company would continue marketing Eyenovia's FDA-approved products while developing new treatment options for glaucoma and other ocular diseases through established partnerships.
- Pooled data from two Phase 3 trials (GOBI and MOJAVE) demonstrate that perfluorohexyloctane ophthalmic solution significantly improves signs and symptoms of dry eye disease (DED). - The analysis included patients with DED associated with Meibomian gland dysfunction (MGD), showing efficacy across various demographic and disease severity subgroups. - Perfluorohexyloctane led to greater reductions in total corneal fluorescein staining (tCFS) and eye dryness visual analog scale (VAS) scores compared to hypotonic saline control. - The most common adverse event was mild, transient blurred vision, suggesting perfluorohexyloctane is generally well-tolerated for treating DED.
