ULTARCORLENE (pivalate de prednisolone)

Opinions on drugs - Posted on Oct 04 2022

Reason for request

First assessment

Key points

Approval of reimbursement for allergy-induced severe inflammatory conditions, and non infectious severe inflammatory conditions of the ocular surface and the anterior segment of the
eye.

Therapeutic improvement?

No therapeutic improvement

Role in therapeutic strategy?

Treatments of allergy-induced severe inflammatory conditions, and non-infectious severe inflammatory conditions of the ocular surface and the anterior segment of the eye generally use local corticosteroids, but depending on the cause, they may be associated with lifestyle and dietary or environmental measures, adjunctive therapies (based on medicinal products or not) or
other local anti-inflammatory treatments (NSAID, ciclosporin) or, in the context of underlying autoimmune diseases, systemic corticosteroid or immunosuppressant treatments.

Role of the medicinal product

ULTARCORLENE 5 mg/g (prednisolone pivalate), eye ointment, is a first-line topical anti inflammatory eye treatment for allergy-induced severe inflammatory conditions, and non infectious severe inflammatory conditions of the ocular surface and the anterior segment of the
eye.

Clinical Benefit

Substantial

The Committee deems that the actual clinical benefit of ULTARCORLENE 5 mg/g (prednisolone pivalate), eye ointment is significant in the marketing authorisation indication.

Clinical Added Value

no clinical added value

Considering:

the partially met medical need particularly in terms of ocular corticosteroid monotherapy, in particular in preservative-free eye ointment form,

But:

the literature data furnished which did not provide evidence of the superiority of 1% prednisolone eye drops over dexamethasone or fluorocortolone eye drops in robust studies,
the lack of studies demonstrating the superiority of 0.5% prednisolone eye ointment over other ophthalmic corticosteroids,

the Committee deems that the proprietary medicinal product ULTARCORLENE 5 mg/g (prednisolone pivalate), eye ointment, provides no clinical added value (CAV) in the management of allergy-induced severe inflammatory conditions, and non-infectious severe
inflammatory conditions of the ocular surface and the anterior segment of the eye.