The National Medicines Safety Agency (ANSM) announces that it has been informed by the Abbvie laboratory of its intention to stop marketing its drug vitamin A Dulcis Ophthalmic ointment, for reasons related to manufacturing. “The judgment comes on June 30, 2025”is it specified in his opinion dated 1is July.
“For several weeks, the ANSM has been very strongly mobilized, in connection with representatives of patient associations and health professionals, to identify immediate and longer term alternatives”, indicates the agency which issues recommendations for use.
In the short term, the ANSM requests to reserve access to the remaining stock of this drug for patients with very severe ophthalmic disorders and who do not respond to first -line treatments.
The indications selected are thus listed:
– severe dry syndromes;
– Resistant and complicated healing of the cornea;
– neurotrophic ulcers;
– Anomalies for the conformation of the eyelids.
The health agency also asks doctors to specify on the order “The number of tubes corresponding to the duration of the prescribed treatment”.
Vigilance on the composition of alternatives
In addition, the ANSM asks pharmacists to reserve the issuance of this drug to patients with a prescription dating from less than a year and give them the right quantity they need. For these patients, the agency adds that “Some comparable composition medical devices can be adapted (notably Vitanuit or Xailin Night)”. But to date, they are not supported by health insurance. The agency ensures, in parallel, actively search for drugs or similar medical devices within the European Union which could be imported or put on the market in France.
For other patients, it is recommended to use therapeutic alternatives, “In particular products based on hyaluronic acid or dexperhenol, some of which are supported on prescription by an ophthalmologist”. The agency calls for vigilance on the composition of these alternatives, “Because some components can sometimes be poorly tolerated in patients”.
In the longer term, the ANSM ensures actively seeking “Laboratories likely to resume the marketing of the ophthalmic ointment vitamin A Dulcis or any other similar drug”.
