Extended indication Treatment for the signs and symptoms of dry eye disease.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Acoltremon
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication Treatment for the signs and symptoms of dry eye disease.
Manufacturer Alcon
Budgetting framework Extramural (GVS)
Additional remarks TRPM8 protein stimulants. Fabrikant: Alcon

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2024
Expected Registration January 2026
Registration phase Clinical trials
Additional remarks NCT05285644 (COMET-2); NCT05360966 (COMET-3)

Therapeutic value

Current treatment options Kunsttranen
Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen fase 3-resultaten bekend.

Expected patient volume per year

References Horizonscan Geneesmidddelen lifitegrast (1).
Additional remarks Prevalentie van ernstige DED is 2 tot 5% (340.000 tot 850.000 patiënten) (1).

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.