Date: 2016-03-14
Type of
information: Results
phase: 2
Announcement: results
Company: Sylentis (Spain)
Product: SYL1001 (tivanisiran)
Action
mechanism:
- RNAi/siRNA. SYL1001 inhibits the capsaicin receptor TrpV1, which is expressed on the surface of the eye. SYL1001 DP is presented in the form of eye drops for treating or preventing eye discomfort associated with dry eye, Sjögren's and other syndromes, and with corneal injuries, with a view to minimising pain and improving patients' quality of life. SYL1001 eye drops is a sterile, isotonic saline solution presented in single-dose vials.
Disease: eye discomfort associated with dry eye syndrome
Therapeutic
area: Ophtalmological diseases
Country: Estonia, Spain
Trial
details:
- SYL1001_II/III are dose-finding, multi-centre randomised parallel-group double-masked placebo-controlled Phase II clinical trials to evaluate the efficacy and safety of SYL1001 in patients with ocular pain related to dry eye syndrome after ten days of treatment (one drop per day in each eye). SYL1001_II included 61 patients at 5 centres in Spain, divided into three groups of 20 patients each, who received SYL1001 (1.125% or 2.25%) or placebo. SYL1001_III included 66 patients at 5 centres in Spain and Estonia, divided into three groups of approximately 22 patients each and treated with SYL1001 (0.375% or 0.75%) or placebo.
- Primary endpoints evaluated were dry eye symptoms using OSDI (Ocular Surface Disease Index) and VAS (Visual Analogue Scale), and signs associated with this pathology (conjunctival hyperaemia and corneal fluorescence staining) after ten days of treatment.
- Secondary endpoints included assessment of vital signs, blood and urine analysis, and alteration of ocular parameters (IOP, TBUT, Schirmer test, visual acuity, and assessment of the anterior segment) together with the appearance of adverse events as a measure of tolerance. (NCT01776658 and NCT02455999)
Latest
news:
- • On March 14, 2016, Sylentis has presented the results of two Phase II dose-finding and efficacy assessment clinical trials (SYL1001_II and SYL1001_III) with the investigational medicinal product SYL1001 for treating ocular discomfort related to dry eye syndrome.These randomised parallel group, double-masked and placebo controlled Phase II trials took place at 8 centres in two European countries: Spain and Estonia. A total of 127 patients with ocular pain related to dry eye syndrome took part in the trials, which assessed safety and efficacy of four doses of SYL1001 (0.375%, 0.75%, 1.125% and 2.25%) against placebo following 10 days of once-per-day administration in the form of eye drops.The results revealed that 1.125% was an optimal dose which achieved the best primary and secondary endpoints, reducing not only ocular pain but also conjunctival hyperaemia related to dry eye syndrome.
The two trials also confirmed a favourable safety and tolerance profile of SYL1001, previously observed in Phase I trial, with no differences in the percentage of adverse events between the assessed doses of SYL1001 and placebo group.
The results and additional analysis of these clinical trials will be presented at the ARVO conference in May 2016.
- • On February 27, 2013, Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia has commenced a Phase II clinical trial with SYL1001 for treating or preventing eye discomfort. The endpoint of this Phase II trial is to determine the analgesic effect of SYL1001 in patients with dry eye and eye discomfort. This is Sylentis's fifth clinical trial using products based on RNAi technology and its second compound to undergo clinical trials, evidencing the company's commitment to developing innovative compounds to treat eye diseases. Sylentis is also the second company in Europe to conduct clinical trials with products based on interference RNA.
- This Phase II trial with SYL1001 will be conducted at Hospital Clínico San Carlos (Madrid), Instituto Oftalmológico Fernández-Vega (Oviedo) and Fundación Jiménez Díaz (Madrid).
Is
general: Yes
