Primo-inscription.
L'essentiel
Avis favorable au remboursement dans l’indication de l’AMM : « Roclanda est indiqué pour la réduction de la pression intraoculaire (PIO) élevée chez les patients adultes atteints de glaucome primitif à angle ouvert ou d’hypertonie oculaire et chez lesquels une monothérapie par prostaglandines ou nétarsudil ne permet pas de réduire suffisamment la PIO. »
Quel progrès ?
Pas de progrès dans la stratégie de prise en charge.
Quelle place dans la stratégie thérapeutique ?
Il s’agit d’un traitement de seconde intention chez les patients atteints de glaucome à angle ouvert ou d’hypertension intraoculaire à réserver en cas de réponse insuffisante aux prostaglandines ou au nétarsudil en monothérapie et lorsqu’un traitement par bithérapie est envisagé.
En raison de la faible robustesse de la démonstration de la non-infériorité et de la dégradation de la tolérance par rapport à GANFORT (bimatoprost, timolol), la Commission recommande de privilégier les associations contenant un bêta-bloquant et d’utiliser ROCLANDA (latanoprost, nétarsudil) en cas de contre-indication aux bêta-bloquants.
Sa formulation contenant un conservateur, son utilisation n’est pas à privilégier par rapport aux collyres sans conservateur, plus particulièrement pour les patients ayant une sécheresse oculaire ou une autre pathologie de la surface oculaire.
| no clinical added value |
Considering:
- demonstration of the superiority of the latanoprost 0.005% + netarsudil 0.2% fixed-dose combination compared to the individual components (latanoprost and netarsudil) in two multicentre, randomised, double-blind studies (MERCURY 1 and 2) conducted in adults with open-eye glaucoma or ocular hypertension in both eyes, for the primary outcome measure of mean IOP determined at each of the 9 measurements performed at 08:00, 10:00 and 16:00 at week 2, week 6 and month 3;
- data after 12 months in the MERCURY 1 study, demonstrating maintenance of the reduction in IOP in the longer term;
- demonstration of its non-inferiority (only in the ITT population, n = 430) compared to the bimatoprost 0.03% + timolol 0.5% combination (GANFORT) in a multicentre, randomised, double-blind study (MERCURY 3) conducted in adults with open-eye glaucoma or ocular hypertension in both eyes and inadequately controlled under treatment and/or requiring treatment with a combination, having shown for the same primary outcome measure as that used in the MERCURY 1 and 2 studies: demonstrated non-inferiority with a confidence interval respecting the non-inferiority margin of 1.5 mmHg for all 9 measurements and respecting the non-inferiority margin of 1.0 mmHg for 6 of the 9 measurements;
- the medical need covered by numerous medicinal products as monotherapy and dual therapy available in the form of fixed-dose combinations but the contraindication against beta-blockers in some patients (particularly in the event of asthma, COPD and cardiovascular diseases) and the absence of reimbursed fixed-dose combinations containing a prostaglandin analogue and a Rho-kinase inhibitor without beta-blockers;
but considering:
- the weakness of the demonstration of the non-inferiority of ROCLANDA compared to GANFORT insofar as:
- the non-inferiority was not confirmed in the per protocol population (PP) (n = 339 patients), with only 8 of the 9 measurements having a confidence interval respecting the non-inferiority margin of 1.5 mmHg;
- demonstration of non-inferiority was sensitive to the choice of missing data imputation method (not quantified);
- an amendment during the study modified the analysis population (from PP to ITT population), with the justification appearing to be inadequate;
- a high number of patients discontinued the study prematurely (15.8%, 25.2% of whom in the ROCLANDA group and 6.1% in the GANFORT group), primarily due to adverse events in the ROCLANDA group (18.3%);
- its less good safety compared to the bimatoprost 0.03% + timolol 0.5% combination (70.2% vs 51.9% for all adverse events and 60.1% vs 30.2% for ocular adverse events);
- the lack of efficacy and safety data beyond 12 months;
the Committee deems that ROCLANDA 50 µg/mL + 200 µg/mL (latanoprost, netarsudil) eye drops, solution provides no clinical added value (CAV V) compared to GANFORT (bimatoprost, timolol). |
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