June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Tivanisiran as a new treatment for Dry Eye in patients with Sjögren Syndrome
Author Affiliations & Notes
  • Victoria Gonzalez
    Clinical, Sylentis, Spain
  • Veronica Ruz
    Sylentis, Spain
  • Anne Marie Bleau
    Clinical, Sylentis, Spain
  • Beatriz Vargas
    Sylentis, Spain
  • Ana Isabel Jimenez
    Sylentis, Spain
  • Footnotes
    Commercial Relationships   Victoria Gonzalez, Sylentis (E); Veronica Ruz, Sylentis (E); Anne Marie Bleau, Sylentis (E); Beatriz Vargas, Sylentis (E); Ana Isabel Jimenez, Sylentis (E)
  • Footnotes
    Support  CDTI-Ministry of Science and innovation- Spain
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 102. doi:
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    • Get Citation

      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)

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Abstract

Purpose : 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.

Methods : 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 : 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).

Conclusions : 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 symptoms of dry eye disease

 

Effects of tivanisiran on signs of dry eye disease

Effects of tivanisiran on signs of dry eye disease

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