RGX-314 Medicine 03 December 2024 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 Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abbvie Portfolio holder Mechanism of action Unknown Route of administration Subretinal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Yes Submission date May 2025 Expected Registration June 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice 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 This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Maculadegeneratiemiddelen. FK. 2024 (1); NCT04704921 (ATMOSPHERE) (2); NCT05407636 (ASCENT) (3). Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks