Favourable opinion for maintenance of reimbursement in the treatment of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis.
Clinical Benefit
Substantial
The clinical benefit of OZURDEX 700 µg (dexamethasone) intravitreal implant in applicator remains substantial in the MA indication.
Clinical Added Value
moderate
Considering:
evidence of the superiority of dexamethasone intravitreal implant (OZURDEX 700 µg) compared to a simulated injection on the proportion of patients with a vitreous haze score of 0 (absence) at week 8 (46.8% versus 11.8%, p < 0.001) in the phase 3 HURON study conducted in adult patients with inflammation of the posterior segment of the eye related to non-infectious uveitis;
a percentage of patients with an improvement in best-corrected visual acuity (BCVA) ≥ 15 letters (ETDRS scale) of 42.9% in the OZURDEX 700 µg group versus 6.6% in the simulated injection group (exploratory results in the absence of control of the alpha risk);
the safety profile marked primarily by ocular adverse effects, in particular those related to the administration of a corticosteroid (elevated intraocular pressure, cataract) and the implant injection procedure (reduced visual acuity, vitreous detachment, vitreous floaters, vitreous opacities, blepharitis, eye pain, photopsia, conjunctival oedema, conjunctival hyperaemia);
data from the French LOUVRE 2 observational study, which are not of a nature to modify the previous assessment of OZURDEX 700 µg (dexamethasone),
the Committee deems that the clinical added value of OZURDEX 700 µg (dexamethasone) intravitreal implant in applicatorremains moderate (CAV III) in the management of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis.
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