BITIFRIN (bimatoprost/timolol) - Glaucoma and ocular hypertension

Opinions on drugs - Posted on Dec 05 2024

Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement in the reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

No clinical added value compared to the reference medicinal product, GANFORT 0.3 mg/5 mg/mL eye drops, solution in single-dose containers.

Clinical Benefit

Substantial

The Committee considers that the clinical benefit of BITIFRIN (bimatoprost/timolol) is substantial in the MA indication.

Clinical Added Value

no clinical added value

This medicinal product is a hybrid that does not provide any clinical added value (CAV V) compared to the reference medicinal product, GANFORT 0.3 mg/5 mg per mL (bimatoprost/timolol) eye drops, solution.