Sylentis a company fo the PharmaMar group with offices and laboratories at QUBE announces results of its Phase III Clinical Trial HELIX with tivanisiran (SYL1001) for the treatment of Dry Eye Syndrome. The HELIX trial has demonstrated an improvement (p=0.035) in the reduction of central corneal damage.
Data will be presented to the FDA and other regulatory authorities in the second trimester of 2019 to define the regulatory strategy. Results of the HELIX trial will be presented in the next international ophtalmology meeting ARVO 2019.
Tivanisiran is an siRNA formed by two chains of Ribonucleic Acid (RNA) one of which is complementary to a segment of the messenger RNA that codes for the TRPV1 protein. Hybridisation (union) of SYL1001 with the TRPV1 mRNA results in the reduction of the translation of TRPV1. This protein has a dual function in in corneal tissues as it participates in the detection, transmission and regulation of pain in the eye as well as a mediator in the innate inflammatory response; two mechanisms in the treatment and prevention of Dry Eye Syndrome.
Dry Eye Syndrome, also known as xeroftalmia, dry querato-conjunctivitis or simply dry eye, is the most prevalent eye disease. Prevalence is about 5 to 30% in population over 50 years, and more frequent in woman.
The disease is characterised, by provoking a dry feeling in the eye and pain, irritation, sensibility to light, burning feeling and even in the worst cases, alteration and loss of vision. This results in a detriment in the quality of life of patients affected by this pathology and affects their everyday life activities like watching television, office working and driving.
Currently, the objective of Dry Eye Syndrome treatments are to alleviate symptoms using artificial eye drops that contribute to the lubrication of the eye and should be applied several times a day. Other treatments include cyclosporin and autologous serum.