Is Ocriplasmin approved by the US FDA?

Drugs@FDA lists 1 application product line for Ocriplasmin, including JETREA (Prescription).

Is Ocriplasmin authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Ocriplasmin.

Are there safety signals or safety updates for Ocriplasmin?

US FDA: 1 entry (latest 2017-02-22).

Active substance

Ocriplasmin

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
JETREA	2.5MG/ML	injectable · intravitreal	THROMBOGENICS, INC	Prescription	17 Oct 2012

EMA European Union — centrally authorised medicines

Jetrea Inceptua AB · Withdrawn · authorised 13 Mar 2013 · ATC S01XA22

Therapeutic indication (EMA)

Jetrea is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

Safety signals and safety-related labeling changes

US FDA 22 Feb 2017 JETREA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for ocriplasmin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.