July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Tivanisiran, a new treatment for Dry Eye Disease, that improved signs and symptoms in clinical trials
Author Affiliations & Notes
  • Ana Isabel Jimenez
    Sylentis, Madrid, Spain
  • Veronica Ruz
    Sylentis, Madrid, Spain
  • Victoria Gonzalez
    Sylentis, Madrid, Spain
  • Covadonga Paneda
    R & D, Sylentis, Tres Cantos, MADRID, Spain
  • Tamara Martinez
    R & D, Sylentis, Tres Cantos, MADRID, Spain
  • Beatriz Vargas
    Sylentis, Madrid, Spain
  • Anne Marie Bleau
    Sylentis, Madrid, Spain
  • Footnotes
    Commercial Relationships   Ana Isabel Jimenez, Sylentis (E); Veronica Ruz, Sylentis (E); Victoria Gonzalez, Sylentis (E); Covadonga Paneda, Sylentis (E); Tamara Martinez, Sylentis (E); Beatriz Vargas, Sylentis (E); Anne Marie Bleau, Sylentis (E)
  • Footnotes
    Support  CDTI-IDI-20170210
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 925. doi:
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      Ana Isabel Jimenez, Veronica Ruz, Victoria Gonzalez, Covadonga Paneda, Tamara Martinez, Beatriz Vargas, Anne Marie Bleau; Tivanisiran, a new treatment for Dry Eye Disease, that improved signs and symptoms in clinical trials. Invest. Ophthalmol. Vis. Sci. 2018;59(9):925.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Dry eye disease (DED) is a multifactorial disease of the tears and the ocular surface that curse with several signs and symptoms. Most approved treatments are aimed to treat a specific parameter of the disease only. Sylentis is developing a new product based in RNA interference, able to treat signs and symptoms of DED.

Methods : Tivanisiran (former SYL1001) is a 19 nucleotide small interference RNA formulated as eye drops, free of antimicrobial agents. Safety studies (Phase I, NCT01438281, EudraCT No: 2010-023113-56) and dose response studies (SYL1001_II, NCT01776658, EudraCT No: 2012-001177-93 & SYL1001_III, NCT02455999, EudraCT No: 2014-004857-15) were carried out with 4 different doses (0.375%, 0.75%, 1.125% and 1.5%) to select the optimum dose to initiate the Phase 3 clinical trials. The dose of 1.125% is currently being assessed in an international, double masked, placebo control clinical trial being conducted in 39 sites in Europe to evaluate the improvement of signs and symptoms of patients with moderate to severe DED (HELIX, SYL1001_IV, NCT03108664, 2016-003903-79).

Results : Results in Phase I trial indicated that tivanisiran was very well tolerated with no drug-related adverse events reported. Pharmacokinetic results indicated that the product was not detected in plasma. In phase II trials, the dose of 1.125% of tivanisiran was significant better than the other doses and placebo in the treatment of patients with DED in terms of hyperemia (p<0.05) and reducing the ocular pain/discomfort (VAS scale) after 10 days of treatment (p=0.016) and this effect was significant from day 4.

Conclusions : These results indicated that tivanisiran is an excellent candidate for the treatment of signs and symptoms of DED with a new mechanism of action based on RNA interference technology. Tivanisiran has demonstrated an improvement of inflammatory ocular parameters, tear quality and ocular discomfort in clinical trials. Tivanisiran is currently being evaluated in Phase 3 clinical trials.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

 

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