Expand all sections

Tarcocimab tedromer

Extended indication Macular edema due to retinal vein occlusion (RVO)
Therapeutic value Possible benefit in ease of use
Registration phase Clinical trials

Product

Active substance Tarcocimab tedromer
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Eye disorders
Extended indication Macular edema due to retinal vein occlusion (RVO)
Manufacturer Kodiac
Route of administration Intravitreal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Fabrikant: Kodiac Sciences Vascular endothelial growth factors inhibitors

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2025
Expected Registration 2026
Orphan drug No
Registration phase Clinical trials
Additional remarks NCT04592419

Therapeutic value

Current treatment options Bevacizumab en aflibercept worden op dit moment off-label gegeven.
Therapeutic value Possible benefit in ease of use
Substantiation Een voordeel is de toediening van eenmaal per 2 maanden ten opzichte van de huidige opties. Het betreft een VEGF-remmer en werkt op dezelfde aangrijpingspunten als de andere beschikbare geneesmiddelen.
Frequency of administration 1 times every 2 months
Dosage per administration 5mg
References NCT04592419
Additional remarks Intravitreal injection of KSI-301 (5mg) at Day 1, Week 4, and once every 8 weeks through Week 20 followed by an individualized dosing regimen of Intravitreal injection of KSI-301 (5mg) from Week 24 to Week 44.

Expected patient volume per year

References Laouri M, Chen E, Looman M, Gallagher M. The burden of disease of retinal vein occlusion: review of the literature. Eye (Lond). 2011 Aug;25(8):981-8. doi: 10.1038/eye.2011.92. Epub 2011 May 6. PMID: 21546916; PMCID: PMC3178209.
Additional remarks Bevolkingsstudies rapporteren een prevalentie van 0,5 tot 2,0% van BVRO en 0,1 tot 0,2% voor CRVO. Ongeveer 5 tot 15% van de ogen met BRVO ontwikkelt macula-oedeem gedurende 1 jaar.

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.