RGX-314

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
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 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.

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).

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

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.