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Victoria Gonzalez, Veronica Ruz, Anne Marie Bleau, Beatriz Vargas, Ana Isabel Jimenez; Tivanisiran as a new treatment for Dry Eye in patients with Sjögren Syndrome. Invest. Ophthalmol. Vis. Sci. 2020;61(7):102.
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© ARVO (1962-2015); The Authors (2016-present)
Sjögren Syndrome is a chronic disease characterized by malfunction of the body's moisture-producing glands, causing mainly dry mouth and dry eyes. Sylentis is developing a new product targeting dry eye signs and symptoms, which has shown higher clinical performance in patients suffering from Sjögren Syndrome.
Tivanisiran (former SYL1001) is a 19-nucleotide small interference RNA designed to silence the transient receptor potential cation channel subfamily V member 1 (TRPV1) mRNA. It is formulated as eye drops, free of antimicrobial agents. A 28-day clinical trial (HELIX, SYL1001_IV, NCT03108664, 2016-003903-79) was carried out to assess its effect on dry eye disease (DED). An exploratory analysis was conducted in patients with Sjögren Syndrome (n=30) for primary and secondary endpoints. Visual analogue scale (VAS) for pain, total Corneal Fluorescein staining (CFS) and hyperemia were the primary endpoints in this clinical trial, whereas DED symptom index, TBUT, areas of CFS, Schirmer test and quality of life questionnaires were included as secondary outcomes.
Results in this phase 3 clinical trial showed an improvement in all VAS parameters (pain, dryness, burning/stinging, itching, foreign body sensation), total CFS (p=0.030) and CFS by areas, as well as in quality of life questionnaires after 28 days of treatment with tivanisiran in patients with Sjögren Syndrome (summary in Figure 1 & Figure 2).
The main signs and symptoms for DED improved in this group of patients, indicating that tivanisiran can be a potential treatment for dry eye in patients with Sjögren Syndrome.
This is a 2020 ARVO Annual Meeting abstract.
Effects of tivanisiran on symptoms of dry eye disease
Effects of tivanisiran on signs of dry eye disease
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