Extended indication Moderately severe to severe non-proliferative diabetic retinopathy in adults and elderly with type 1 or 2 diabetes mellitus.
Registration phase Clinical trials

Product

Active substance Tarcocimab tedromer
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Diabetes
Extended indication Moderately severe to severe non-proliferative diabetic retinopathy in adults and elderly with type 1 or 2 diabetes mellitus.
Proprietary name KSI-301
Manufacturer Kodiac
Portfolio holder Kodiac
Mechanism of action Other, see general comments
Route of administration Ocular
Therapeutical formulation Solution
Budgetting framework Intermural (MSZ)
Additional remarks KSI-301 is een anti-VEGF therapie die gebruik maakt van Kodiak Sciencesʼ Antibody Biopolymer Conjugate (ABC) Platform.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2026
Expected Registration 2027
Orphan drug No
Registration phase Clinical trials
Additional remarks Primary completion (estimated): 30 december 2025.

Therapeutic value

References NCT05066230 (GLOW1); NCT06270836 (GLOW2)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Cost 3,700.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (S01LA - anti‑neovascularisatie middelen) geneesmiddelen in Nederland.

Potential total cost per year

Off label use

Indication extension

Other information