VANCOUVER, British Columbia – Results from phase 2 and phase 3 trials showed that tivanisiran 1.125% significantly improved ocular discomfort/pain and conjunctival hyperemia in patients with dry eye and also confirmed its safety profile.
Ruz and colleagues from Sylentis, manufacturer of the small interfering ribonucleic acid (siRNA) inhibitor tivanisiran, conducted two multicenter, randomized, vehicle-controlled studies in six countries. SYL1001-II was the phase 2 trial, and Helix was phase 3.
According to the study, which was presented here at the Association for Research in Vision and Ophthalmology meeting, 1.125% was identified in phase 2 as the most effective dose to reduce the Visual Analogue Scale score for eye discomfort/pain, corneal fluorescein staining and conjunctival hyperemia. Secondary outcomes in the phase 3 trial included tear break-up time, Schirmer test and quality of life questionnaires.
In Helix, 289 patients received tivanisiran sodium or placebo as preservative-free eye drops once daily for 10 or 28 days, respectively.
The authors reported in the abstract that tivanisiran 1.125% improved conjunctival hyperemia in 50% of patients compared to 20% for placebo (P < .05). In addition, corneal fluorescein staining and tear break-up time improved over baseline. Compliance was high, with only 18 mild to moderate adverse events that were not unexpected.
Sylentis stated in a press release that the Helix trial indicated statistically significant improvement in signs and symptoms for patients with Sjögren’s syndrome. The reduction in central corneal damage seen in the study, “is of great clinical relevance since the central area of the cornea is densely innervated and participates in visual performance.”
Ana Isabel Jiménez, Sylentis COO and director of research and development, said in the press release: “These results support the potential of tivanisiran in the treatment of dry eye signs and symptoms. We trust in our technology and hope that this investigational drug may soon become a real alternative for treating the millions of dry eye sufferers around the world.” – by Nancy Hemphill, ELS, FAAO
Ruz R, et al. Clinical results of tivanisiran, a siRNA for the treatment of dry eye disease. Presented at: Association for Research in Vision and Ophthalmology; Vancouver, British Columbia; April 28-May 2, 2019.
Disclosures: Ruz and colleagues are employed by Sylentis.