ILUVIEN 190 µg (acetonide de fluocinolone) (prevention rechute uveite)
Reason for request
Key points
Favourable opinion for reimbursement in the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.
What therapeutic improvement?
No clinical added value in the therapeutic strategy.
Role in the care pathway?
The preventive treatment of recurrent non-infectious uveitis is not standardised and will depend primarily on the aetiology of the eye inflammation.
Currently, intra/periocular corticosteroids are used to treat, as they occur, relapses of recurrent non-infectious uveitis not requiring systemic treatment (idiopathic involvement, purely ophthalmological involvement) or uveitis requiring intraocular corticosteroid treatment in addition to systemic treatment (particularly in recurrent severe involvement despite maximum systemic treatment).
In the event of inflammatory recurrence in a patient having required the use of a systemic corticosteroid, this may be prolonged and/or increased and the patient may receive corticosteroid-sparing therapy (immunosuppressant, biotherapy). These substances will be maintained as long-term therapy with the objective of preventing a further inflammatory relapse. Hence in routine practice, systemic corticosteroids, as well as any immunosuppressant or immunomodulatory (biotherapy) treatments are used in the prevention of relapse in recurrent non-infectious posterior uveitis. However, they have significant systemic adverse effects.
Role of the medicinal product in the care pathway
ILUVIEN (fluocinolone acetonide intravitreal implant) is a first-line intraocular corticosteroid treatment in the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye, with unilateral or asymmetric bilateral involvement.
ILUVIEN (fluocinolone acetonide) should be administered following a recurrence under OZURDEX (dexamethasone vitreal implant) and respecting the following conditions:
- uveitis aetiology not requiring systemic treatment (idiopathic involvement, purely ophthalmological involvement) or requiring intraocular corticosteroid treatment in addition to systemic treatment (particularly in recurrent severe involvement despite maximum systemic treatment);
- pseudophakic patient or patient having already had a cataract (do not inject into a young patient with a clear lens);
- absence of ophthalmological contraindications: uncontrolled glaucoma, aphakic patient, iris or scleral-fixated implant, wide peripheral iridectomy, history of infection (in particular toxoplasmosis, ocular herpes).
Clinical Benefit
Substantial |
The Committee deems that the clinical benefit of ILUVIEN (fluocinolone acetonide) intravitreal implant is substantial in the MA indication extension to the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. |
Clinical Added Value
no clinical added value |
The Committee deems that ILUVIEN (fluocinolone acetonide) intravitreal implant provides no clinical added value (CAV V) compared to the current management, in adults, of relapses in recurrent non-infectious uveitis affecting the posterior segment of the eye. |