The primary endpoint was reached, a mean gain from baseline was observed in a middle dose (25mg/ml), reaching statistical significance (p = 0.045). 71.4% of patients in the middle dose levels maintained visual acuity over the 6-week study period. The study evaluated the preliminary efficacy and safety of three dose levels of SYL1801, a novel siRNA administered […]
Category Archives: Destacada
Destacada
Sylentis, a PharmaMar Group company, announces the FYDES study to evaluate the safety of tivanisiran in patients with dry eye disease has met its primary endpoint
18
Dec
Dec
FYDES achieved the primary endpoint of the study by demonstrating the long-term safety of tivanisiran ophthalmic solution administration. 301 patients with dry eye disease recruited from 26 centers in the United States participated. Madrid, December 18th, 2023. – Sylentis, a wholly owned subsidiary of PharmaMar (MSE:PHM), has obtained the results of the FYDES clinical trial […]
Destacada
Sylentis, a PharmaMar Group company, begins a new Phase II trial with SYL1801 for patients with Age-Related Macular Degeneration
23
Nov
Nov
Madrid, November 23rd, 2022. – Sylentis, a PharmaMar Group Company (MSE:PHM), has announced today the recruitment of the first patient in a new Phase II dose-ranging trial with its compound SYL1801, for the treatment of patients with neovascular Age-related Macular Degeneration (AMD). This is a randomized, double-blind Phase II trial with three parallel groups in […]
Destacada
Sylentis, a wholly owned subsidiary of PharmaMar, inaugurates first oligonucleotide manufacturing plant in Spain
19
Apr
Apr
The plant, which has a surface area of 400m2, will serve both Sylentis’ manufacturing needs and those of other pharmaceutical companies. Madrid, April 19th, 2022. – Sylentis, a wholly owned subsidiary of PharmaMar (MSE:PHM), today inaugurated the first plant in Spain and the third in Europe for the manufacture of oligonucleotides approved under GMP (Good […]
Destacada
Sylentis initiates a new Phase III trial in the United States to evaluate the safety of tivanisiran in patients with dry eye disease
01
Apr
Apr
This Phase III study, called FYDES, will involve 26 hospitals in the United States. It will evaluate the long-term safety of tivanisiran ophthalmic solution in patients with mild to severe dry eye disease. The study has been authorized by the FDA and will be part of the New Drug Application. Madrid, April 1st, 2022. – […]
14
Mar
Mar
This trial involved 36 healthy volunteers who were administered eye drops for the treatment and/or prevention of retinal diseases, such as macular degeneration. This study provides evidence that SYL1801 is safe and well tolerated; therefore, the Phase I has met the primary safety endpoint. SYL1801 has been developed by Sylentis and is based on RNA […]
Destacada
Sylentis, PharmaMar Group, initiates a Phase I clinical trial with SYL1801 for retinal diseases
18
Mar
Mar
This Phase I trial will enroll 36 healthy volunteers and will be conducted at the Hospital Universitario Ramón y Cajal in Madrid (Spain). The safety of SYL1801 at different doses, as well as its pharmacokinetic profile, will be evaluated. SYL1801 has been developed by Sylentis and is based on RNA interference (RNAi) technology. The compound […]
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