Author Archives: sylentis

Sylentis, a PharmaMar Group company, begins a new Phase II trial with SYL1801 for patients with Age-Related Macular Degeneration

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 […]

Sylentis, a wholly owned subsidiary of PharmaMar, inaugurates first oligonucleotide manufacturing plant in Spain

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 […]

Sylentis initiates a new Phase III trial in the United States to evaluate the safety of tivanisiran in patients with dry eye disease

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. – […]

Sylentis, PharmaMar Group, completes Phase I trial with SYL1801 for retinal diseases

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 […]

Sylentis, PharmaMar Group, initiates a Phase I clinical trial with SYL1801 for retinal diseases

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 […]

FDA authorizes Sylentis (PharmaMar Group) to initiate Phase III trial with tivanisiran for the treatment of dry eye disease

This Phase III study, called SYL1001_V, will involve more than 30 hospitals in the United States. It will evaluate the efficacy and safety of tivanisiran ophthalmic solution on the signs and symptoms of patients with dry eye disease associated with Sjögren’s Syndrome. The study has been approved by the FDA in 30 days and will […]

Sylentis (PharmaMar Group) presents new results of tivanisiran for the treatment of dry eye disease

In patients with Sjögren’s Syndrome, where the inflammatory component of the disease is more exacerbated, there is a statistically significant improvement in both signs and symptoms (p<0.05). Patients with dry eye disease treated with tivanisiran showed a statistically significant reduction in the central corneal damage (p<0.05). Sylentis has met at ARVO with recognized experts in […]

Sylentis (PharmaMar Group) presents its new drug for retinal diseases at ARVO

The application of SYL1801 in eye drops could be a new therapeutic option for the treatment of retinal diseases characterized by neovascular processes, as opposed to the ocular injection used in current treatments. SYL1801 administered in eye drops reduces angiogenesis (blood vessel formation) in an animal model of laser-induced neovascularization, similar to intravitreally injected anti-VEGF […]

Sylentis (PharmaMar Group) at ARVO 2019 with results from two ophthalmic drugs: tivanisirán and SYL1801

The company will present results of the HELIX clinical trial with tivanisirán for the treatment of Dry Eye Syndrome, in which an improvement in central corneal damage and results in patients with Sjögren’s Syndrome are demonstrated. Sylentis will also present data from the development of SYL1801 for the treatment and prevention of diseases of the […]

Sylentis announces results of Phase 3 HELIX trial with tivanisiran for the treatment of Dry Eye Disease

The HELIX trial has shown improvement (p=0.035) in the reduction of central corneal staining Data will be presented to the FDA and other regulatory authorities during the second quarter of 2019 to define the regulatory strategy The results of the HELIX trial will be presented at the Annual Congress of the Association for Research in […]

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