相关临床试验
10
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
N/A
已完成
9
90.0%
Unknown
1
10.0%
暂无批准数据
- Apellis Pharmaceuticals announced 5-year GALE extension study data demonstrating that SYFOVRE (pegcetacoplan injection) delayed geographic atrophy lesion growth by approximately 1.5 years compared to sham treatment. - Both monthly and every-other-month dosing regimens of SYFOVRE showed similar efficacy in delaying disease progression in patients with nonsubfoveal geographic atrophy secondary to age-related macular degeneration. - The safety profile of SYFOVRE remained consistent with previously reported data through five years of continuous treatment, with no new safety signals identified. - The GALE study represents the most extensive dataset in geographic atrophy research, providing insights into the natural progression of this leading cause of blindness affecting over one million Americans.
- The HELIOS trial revealed OTX-TKI was well-tolerated with no serious adverse events, with all diabetic retinopathy severity score improvements occurring in the treatment arm and all worsening in the sham arm. - Post-hoc analysis using ultrawidefield fluorescein angiography showed reduced retinal leakage in OTX-TKI-treated patients, while sham group patients experienced worsening leakage across total retina, peripheral retina, and posterior pole. - Notably, vision-threatening complications were completely absent in the OTX-TKI treatment group, with researchers expressing optimism about tyrosine kinase inhibitors potentially providing sustained biological activity for 6-12 months.
- Interim 48-week data from the Phase 1 HELIOS trial demonstrates that a single injection of OTX-TKI (sustained-release axitinib implant) prevented disease progression in patients with moderately severe to severe non-proliferative diabetic retinopathy. - The bioresorbable implant showed significant efficacy with 46.2% of treated patients experiencing DRSS improvement compared to 0% in the sham group, while no OTX-TKI patients developed vision-threatening complications versus 37.5% in the control arm. - OTX-TKI was well-tolerated with no reports of ocular serious adverse events or intraocular inflammation, suggesting potential as a durable treatment requiring only 1-2 injections per year to manage NPDR.
