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RGX-314

Extended indication RGX-314 monotherapy for treatment of wet age-related macular degeneration in adults over 50 years of
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance RGX-314
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication RGX-314 monotherapy for treatment of wet age-related macular degeneration in adults over 50 years of age and elderly previously treated with anti-VEGF therapy
Manufacturer Abbvie
Route of administration Subretinal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP Yes
Submission date May 2025
Expected Registration June 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks Indieningsdatum gebaseerd op primary completion datum in februari 2025.

Therapeutic value

Current treatment options Lokale VEGF-remmers (aflibercept, bevacizumab, brolucizumab, faricimab, ranibizumab) (1)
Therapeutic value No estimate possible yet
Duration of treatment one-off
References Maculadegeneratiemiddelen. FK. 2024 (1); NCT04704921 (ATMOSPHERE) (2); NCT05407636 (ASCENT) (3).

Expected patient volume per year

References Declaratiedata. 2024 (1).
Additional remarks Jaarlijks zijn er ongeveer 40.000 patiënten die een VEGF-remmer voorgeschreven krijgen voor natte leeftijdsgebonden maculadegeneratie (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.