Sylentis has released promising topline results from its Phase 2a study evaluating SYL1801, an eye drop therapy for the treatment of neovascular age-related macular degeneration (nAMD).
The double-blinded study evaluated three parallel dose level cohorts of SYL1801, an investigational siRNA therapy administered via eye drops, unlike other treatments that require intravitreal injection.
nAMD patients in the study were treatment-naïve though 42 days. A total of 99 subjects were enrolled across 21 centres in Europe. The primary endpoint was to evaluate the effect of SYL1801 on the change from baseline to the final visit (end of treatment) in best corrected visual acuity (BCVA) score. All dose-levels of SYL1801 maintained visual acuity similarly throughout the duration of the study. The middle concentration of 25 mg/ml achieved a statistically significant improvement of visual acuity at 42 days (p=0.045), Sylentis said.
Sylentis said the findings mark a significant advancement in non-invasive treatment options for retinal diseases traditionally managed through intravitreal injections.1 The results of the Phase 2a trial were shared in a scientific poster during the 2025 Association for Research in Vision and Ophthalmology (ARVO) annual meeting, held from 4–8 May in Salt Lake City in Utah, United States.
Sylentis said the findings mark a significant advancement in non-invasive treatment options for retinal diseases traditionally managed through intravitreal injections
Reference
- PharmaMar, Sylentis, a PharmaMar Group company, announces the positive results of the Phase IIa dose-ranging study for SYL1801 in patients with age-related macular degeneration (AMD), (media release, 5 May 2025) available at: pharmamar.com/en/sylentis-a-pharmamar-group-company-announces-the-positive-results-of-the-phase-iia-dose-ranging-study-for-syl1801-in-patients-with-age-related-macular-degeneration-amd/ [accessed May 2025].
