Effect of NOVA22007 after treatment discontinuation in DED patients

• Research type

  Research Study

• Full title

  A Multicenter, Open Label, Interventional, Prospective, Non Randomized, One Cohort Extension Study To Assess the Sustainability of the Effect of NOVA22007 Following Treatment Discontinuation in Improved Patients With Severe Dry Eye Disease (DED

• IRAS ID

  113954

• Contact name

  Francisco Figueiredo

• Sponsor organisation

  Novagali Pharma SAS

• Eudract number

  2012-002066-12

• ISRCTN Number

  N/A

• Research summary

  More than 100 million of patients around the world suffer from Dry Eye Disease (DED). DED is characterized by symptoms that cause discomfort, visual disturbance and potential damage to the ocular surface. The efficacy of Ciclosporin (CsA) has already been studied in several randomized clinical studies versus placebo in order to obtain Marketing Authorization of Restasis© in the United States (an anionic emulsion containing 0.05% of Ciclosporin). During a previous clinical Phase III study (NVG06C103) in 492 patients with moderate to severe DED in Europe, NOVA 22007© demonstrated a statistically significant improvement in corneaflurescein staining (CFS) after 6 months of treatment. The study revealed no safety concerns and no unsuspected adverse events occurred. Post hoc data analysis showed the greatest treatment benefit with NOVA 22007© over the vehicle occurred in patients with severe DED (grade 4 CFS) with the highest levels of ocular surface inflammation at baseline. Based on this insight, we chose to include only patients with severe DED in a new study (NVG10E117 ??Sansika Study), as these patients should be the ones that will benefit the most from treatment with CsA. The 12-month Sansika study was to demonstrate the superiority of NOVA22007 over vehicle and to evaluate the ocular tolerability and safety of NOVA22007. The proposed study (NVG12D122) is an extension of the Sansika study, that will last 24 months. The aim of the proposed study is to assess the sustainability of the effect of NOVA22007 following treatment discontinuation and to estimate for how long improved patients do not absolutely need NOVA22007 treatment. It will also be possible to identify prognostic factors that flunce markedly the time to relapse, to estimate the onset of action of the drug following treatment resumption, and to eventually estimate for how long patients need and do not need NOVA22007 treatment.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  12/NE/0403

• Date of REC Opinion

  25 Jan 2013

• REC opinion

  Further Information Favourable Opinion