Extended indication Citicoline in combination with intraocular pressure lowering agent for preventive treatment of progressing open angle glaucoma in adults and elderly.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Citicoline
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication Citicoline in combination with intraocular pressure lowering agent for preventive treatment of progressing open angle glaucoma in adults and elderly.
Manufacturer Omikron Italia
Portfolio holder Omikron Italia
Route of administration Ocular
Therapeutical formulation Eye drops
Budgetting framework Extramural (GVS)
Additional remarks Fosfatidylcholinestimulant

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2025
Expected Registration December 2026
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Substantiation Uit een kleine trial bleek effect. Er loopt nu nog een fase 3 aanvullende therapie.
Frequency of administration 3 times a day
References NCT05710198
Additional remarks Driemaal daags één druppel in het oog.

Expected patient volume per year

Patient volume 120,000 - 140,000

Market share is generally not included unless otherwise stated.

References VZinfo.nl
Additional remarks In 2023 waren er ongeveer 384.600 mensen met glaucoom bekend bij de huisarts. POAG is meest voorkomende vorm van glaucoom. De prevalentie van POAG in Nederland is ongeveer 1%, dus rond de 200.000 mensen. Ongeveer 60 tot 70% daarvan wordt behandeld met medicatie.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information