Pharma Mar’s Sylentis will conduct a trial in more than 30 hospitals in the U.S.

Pharma Mar’s Sylentis will conduct a trial in more than 30 U.S. hospitals. The PharmaMar group company announced Thursday, March 4th, that the U.S. Food and Drug Administration (FDA) has authorized the start of a Phase III clinical trial with the ophthalmic solution (eye drops) tivanisiran for the treatment of dry eye disease associated with Sjögren’s syndrome.

The study design has been approved by the FDA in 30 days and will be part of the marketing authorization application, which will include another Phase III trial. This study will involve more than 30 hospitals in the United States and 200 patients. It is a randomized, double-masked, placebo-controlled study, whose primary and secondary objectives are, respectively, to evaluate the efficacy (signs and symptoms) and safety of tivanisiran in patients with dry eye disease associated with Sjögren’s Syndrome. This Phase III trial will not be conducted in Spain.  

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Sylentis receives FDA green light for a trial of its ophthalmic solution for dry eye disease

Tivanisiran represents a breakthrough in the development of innovative drugs in different therapeutic areas through gene silencing technology based on RNA interference (RNAi). It is a drug administered in drops to control the inflammation and pain characteristic of this pathology.

Both the design of the protocol for this trial and its authorization by the regulatory authorities are based on the scientific evidence of safety and efficacy obtained in the phase III Helix trial. In this study, a significant improvement in signs and symptoms was observed in the subgroup of patients with Sjögren’s syndrome, which is a more severe form of dry eye disease.

In the words of Ana Isabel Jiménez, head of research and development (R&D) at Sylentis, “the start of this trial in the United States represents an important step towards advancing our goal of offering innovative therapies to patients with ocular surface diseases.”  

Pharma Mar closed 2020 with revenues of $165 million (€137 million) 

Pharma Mar achieved its best-ever results in 2020, with revenues of $165 million (€137 million), compared with a loss of $10.9 million (€9.1 million) in 2019. The group tripled its revenues in 2020 to $325 million (€270 million), compared with the $103 million (€85.8 million) posted in 2019, representing growth of 215%. 

Total oncology sales were $120.4 million (€100 million), up 38% from a year earlier. Pharma Mar recorded its first revenues from sales of lurbinectedin on compassionate use in certain European countries in 2020. This item recorded total revenues of $25.9 million (€21.5 million). In addition, royalty revenues jumped by 405% to $18.8 million (€15.6 million).

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(Featured image by 12019 via Pixabay)

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