Listen
CYSTADROPS (mercaptamine [cysteamine] hydrochloride), ophthalmic medicinal product
OPHTHALMOLOGY - New medicinal product
Opinions on drugs -
Posted on
Mar 29 2018
Reason for request
Inclusion
Substantial clinical benefit and minor clinical added value in the treatment of corneal cystine deposits in adults and children over 2 years of age with cystinosis
- CYSTADROPS (0.55% cysteamine) has Marketing Authorisation in the treatment of corneal cystine deposits in adults and children over 2 years of age with cystinosis. Before this authorisation, French patients were treated with a hospital preparation of 0.1% cysteamine prepared by the General Agency for Health Equipment and Products (AGEPS); this preparation is no longer produced.
- One study demonstrated at 90 days the superiority of CYSTADROPS vs AGEPS-prepared 0.10% cysteamine hydrochloride eye drops on a surrogate endpoint (reduction of density of corneal cystine deposits) with a modest additional effect size.
- The long-term progression of ocular morbidity with CYSTADROPS is unknown due to the lack of robust data.
- CYSTADROPS contain benzalkonium chloride as a preservative, which can cause adverse effects in the form of conjunctivitis and ocular surface toxicity.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| minor |
- |
English version
Contact Us
Évaluation des médicaments
