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Ocriplasmin

Phase 4

Symptomatic Vitreomacular Adhesion | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Nov 30, 2015

Ocriplasmin development status

Highest phase Phase 4 (NCT02035748)
Phase scored for ALCPhase 3
Registered trials 2 across 1 sponsor since Jun 2013

Ocriplasmin target and mechanism

Molecular targetLAMA1, LAMA2, LAMA3, LAMA4, LAMA5, LAMB1
Target classHydrolytic Enzyme
ModalitySmall molecule

Also known as A01016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLED
Total Trials1
Total Enrollment251

FDA Designations

No designations recorded

Ocriplasmin clinical trials

Ocriplasmin · 1 trial · 1 indication

Phase 3 1
NCT01889251A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular AdhesionSymptomatic Vitreomacular Adhesion
COMPLETED251 Analytics
PHASE3COMPLETED
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Symptomatic Vitreomacular AdhesionUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
Day 28

VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OcriplasminEXPERIMENTALOcriplasmin administered as a single intravitreal injection to the study eye at baseline
Sham injectionSHAM_COMPARATORSingle sham injection to the study eye at baseline

Interventions

NameTypeDescription
OcriplasminDRUG -
Sham injectionDRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function; * Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye; * BCVA of 20/800 or better in the non-study eye; * Provide written informed co...

Countries:Japan
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Frequently asked questions about Ocriplasmin

What is ocriplasmin?

Ocriplasmin is an investigational small molecule developed by Alcon Inc. (ticker ALC) for symptomatic vitreomacular adhesion, an eye condition in which the vitreous gel adheres abnormally to the macula. It is being studied as a pharmacological option in ophthalmology and has completed a Phase 3 clinical trial in Japan.

What is ocriplasmin used for in symptomatic vitreomacular adhesion?

Ocriplasmin is being developed to treat symptomatic vitreomacular adhesion, a condition where the vitreous gel remains abnormally attached to the macula and causes symptoms. The clinical program targets adults aged 20 years and older with this diagnosis. It is investigational and has not been established as a marketed treatment.

What does ocriplasmin target?

Ocriplasmin targets laminin proteins, specifically LAMA1, LAMA2, LAMA3, LAMA4, LAMA5, and LAMB1. It is a hydrolytic enzyme, meaning it acts by breaking down these laminin substrates. Laminins are components of the extracellular matrix at the vitreoretinal interface, which is relevant to its proposed activity in vitreomacular adhesion.

Who makes ocriplasmin?

Ocriplasmin is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program evaluating the drug in symptomatic vitreomacular adhesion. The compound is also identified by the ChEMBL ID CHEMBL2095222.

What phase is ocriplasmin in?

Ocriplasmin is in Phase 3 development for symptomatic vitreomacular adhesion. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and is not described as approved by the FDA for this indication.

What clinical trials is ocriplasmin in?

Ocriplasmin has been studied in the Phase 3 trial NCT01889251, titled A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion. That trial enrolled 251 participants in Japan, was randomized, double blind, and sham controlled, and has completed. No trials are currently active.