Date: 2011-06-06
Type of
information: Clinical trial authorisation
phase: 1
Announcement: clinical trial authorization
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
Therapeutic
area: Ophtalmological diseases
Country: Spain
Trial
details:
Latest
news:
- • On June 6, 2011, Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia, has received authorisation from the Spanish Medicines and Health products Agency to commence clinical trials with SYL1001 for treating or preventing eye discomfort. The endpoint of the Phase I trial is to determine the compound's safety and tolerance in healthy volunteers. The Phase I trial with SYL1001 will be performed on healthy volunteers at the Navarra University Clinic.
Is
general: Yes
