CATIOLANZE (latanoprost) - Angle glaucoma or ocular hypertension

The Committee deems that the clinical benefit of CATIOLANZE 50 µg/ml eye drops, emulsion is substantial in the MA indications.

Considering:

• evidence of the non-inferiority of CATIOLANZE (preservative-free latanoprost) compared to XALATAN (latanoprost with preservative) on the reduction of intraocular pressure morning and evening after 12 weeks of treatment,
• evidence of the superiority of CATIOLANZE compared to XALATAN on the reduction in corneal fluorescein staining (CFS) score in patients with a CFS score ≥ 1 at baseline, after 12 weeks of treatment, 

but: 

• the lack of evidence of a superiority of CATIOLANZE compared to XALATAN after 12 weeks for:
  • the reduction of IOP morning and evening, given the non-significant difference between the two groups for the evening measurement,
  • the change in ocular surface disease (OSD) score, in patients with a mean score of > 0 at baseline,
• the short-term safety profile (12 weeks) of CATIOLANZE similar to that of XALATAN and primarily marked by ocular adverse events, such as ocular and conjunctival hyperaemia, eye irritation, punctate keratitis, eye pain, photophobia or conjunctivitis, and adverse effects related to the prostaglandin analogue class (iris hyperpigmentation, eyelash growth),
• the absence of long-term comparative safety data versus XALATAN enabling an advantage of the preservative-free formulation to be demonstrated, 

the Committee deems that CATIOLANZE 50 µg/ml eye drops, emulsion provides no clinical added value (CAV V) compared to XALATAN (latanoprost) eye drops, solution.