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Sylentis’ dry eye drug misses goals in Phase III study

06/02/2019By Callum Glennen
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Sylentis’ dry eye disease (DED) drug tivanisiran has failed to meet the primary objectives of a Phase III clinical trial investigating its effectiveness.

The ‘Helix’ study, which compared the tivanisiran-based eye drop siRNA to artificial tears, found there was no statistically significant difference between the two treatments in terms of reducing ocular pain and total corneal staining.

The study included 330 patients, and was undertaken across location in Spain, Germany, Estonia, Portugal, Slovakia and Italy.

Professor José Manuel Benítez del Castillo, the study’s principal investigator said finding a solution to DED is important. “Tivanisiran could be a therapeutic alternative for these patients as it is a drug with a new mechanism of action.”

There were some positive findings in the report. A statistically significant improvement was observed in central corneal staining. According to medial news website FierceBiotech.com, if this result can be reproduced tivanisiran may be effective at improving a particular part of the cornia.



“Improving one area of the corneal staining has been recognised by agencies for the approval of other products.”
Dr Ana Isabel Jiménez, Sylentis

Additionally, the trial did not reveal any serious adverse effects related to the use of tivanisiran.

The study included 330 patients, and was undertaken across location in Spain, Germany, Estonia, Portugal, Slovakia and Italy.

Professor José Manuel Benítez del Castillo, the study’s principal investigator said finding a solution to DED is important. “Tivanisiran could be a therapeutic alternative for these patients as it is a drug with a new mechanism of action.”

Dr Ana Isabel Jiménez, chief operating officer and R&D director of Sylentis, said the company is looking for to discuss the findings with the FDA and other regulatory bodies. “Improving one area of the corneal staining has been recognised by agencies for the approval of other products.”

Tivanisiran is designed to treat DED by genetic silencing through RNA interference. Administered as eye drops, the drug selectively inhibits the production of the transient receptor potential cation channel, which mediates the transmission of ocular pain.

AFT Pharmaceuticals
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Sylentis is a Spain-based biopharmaceutical company focusing on therapies that involve gene silencing or RNA interference.

 

More reading:

Genetic silencing treatment effective against dry eye

 

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