SYL1801 / PharmaMar - LARVOL DELTA

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) (Pharmamar Press Release) - P2a | N=90 | NCT05637255 | Sponsor: Sylentis, S.A. | "The double-blinded study evaluated three parallel dose level cohorts of SYL1801 in treatment-naïve eyes of nAMD patients though 42 days. A total of 99 subjects were enrolled across 21 centers 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 BCVA (Best Corrected Visual Acuity) score. All dose-levels of SYL1801 maintained visual acuity similarly throughout the duration of the study. The middle concentration of 25mg/ml achieved a statistically significant improvement of visual acuity at 42 days (p=0.045). In this clinical trial, SYL1801 was well tolerated with no ≥3 treatment related adverse events....71.4% of patients in the middle dose levels maintained visual acuity over the 6-week study period....The results of the study have been presented at ARVO 2025..."

P2a data • Wet Age-related Macular Degeneration

Clinical trial for SYL1801, a new siRNA-Based Treatment for Neovascular AMD. (ARVO 2025) - P2 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Stability study of a preservative-free formulation of SYL1801, a siRNA indicated for neovascular AMD, in Novelia® multidose eye dropper (ARVO 2023) - P2 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Sylentis, S.A.

New P2 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Phase I of SYL1801, a new siRNA delivered in eye drops for age-related macular degeneration (ARVO 2022) - "This study provides evidence that SYL1801, a new siRNA administered in eye drops for retinal diseases, is safe and well tolerated. Few related AEs occurrence together with limited systemic bioavailability supports good safety profile. This, together with in vitro and in vivo efficacy data, further supports clinical development of SYL1801."

P1 data • Age-related Macular Degeneration • Dry Eye Disease • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders