Ocriplasmin

Overview

Ocriplasmin is a recombinant truncated form of human plasmin with a molecular weight of 27.2 kDa produced by recombinant DNA technology in a Pichia pastoris expression system. Ocriplasmin is a protein made up of 249 amino acids and has two peptide chains. Agent for pharmacologic vitreolysis; thrombolytic agent. FDA approved in October 17, 2012.

Background

Indication

Ocriplasmin is a proteolytic enzyme indicated for the treatment for symptomatic vitreomacular adhesion.

Associated Conditions

Symptomatic Vitreomacular Adhesion (VMA)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase I RVC With Ocriplasmin for CRVO	2016/04/21	NCT02747030	Phase 1	Completed	Universitaire Ziekenhuizen KU Leuven
A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR	2016/02/12	NCT02681809	Phase 2	Terminated	ThromboGenics
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion	2014/12/23	NCT02322229	Phase 4	Completed	Alcon Research
Assessment of Patients Treated With JETREA® for Vitreomacular Traction	2014/01/14	NCT02035748	Phase 4	Completed	Alcon Research
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion	2013/06/28	NCT01889251	Phase 3	Completed	Alcon Research
Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole	2011/09/07	NCT01429441	Phase 3	Completed	ThromboGenics
Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies	2011/02/02	NCT01287988	N/A	Completed	ThromboGenics
Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema	2010/09/03	NCT01194674	Phase 1	Terminated	National Institutes of Health Clinical Center (CC)
The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)	2010/07/09	NCT01159665	Phase 2	Completed	ThromboGenics
Safety and Efficacy Study of Microplasmin in for Non-Surgical Treatment of Focal Vitreomacular Adhesion	2010/01/25	NCT01055535	Phase 2	Completed	ThromboGenics

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Jetrea	Inceptua AB,Gustavslundsv. 143,16751 Bromma,Sweden	Authorised	3/13/2013
Jetrea	Inceptua AB,Gustavslundsv. 143,16751 Bromma,Sweden	Authorised	3/13/2013

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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