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Brimo PS DDS

Phase 2

Patients Who Participated in an Intravitreal Brimo PS DDS® Study | Small molecule | Ophthalmology |AbbVie Inc.|Trials Updated: Feb 20, 2015

Brimo PS DDS development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2010

Brimo PS DDS target and mechanism

Molecular targetADRA2A, ADRA2C, ADRA2B
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

SHAM_CONTROLLED
Total Trials1
Total Enrollment215

FDA Designations

No designations recorded

Brimo PS DDS clinical trials

Brimo PS DDS · 1 trial · 1 indication

Phase 2 1
NCT01080209Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery SystemPatients Who Participated in an Intravitreal Brimo PS DDS® Study
COMPLETED215 Analytics
PHASE2COMPLETED
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Patients Who Participated in an Intravitreal Brimo PS DDS® StudyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients With No Visible Implants in the Study Eye
Month 36

Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.

Secondary Endpoints

Number of Patients With Vision Loss in the Study Eye
Baseline of Parent Study, Month 36
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Brimo PS DDS® 400 μg (2 implants)EXPERIMENTALPatients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
Brimo PS DDS® 400 μg (1 implant)EXPERIMENTALPatients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
Brimo PS DDS® 200 μg (2 implants)EXPERIMENTALPatients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
Brimo PS DDS® 200 μg (1 implant)EXPERIMENTALPatients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
Brimo PS DDS® 100 μg (1 implant)EXPERIMENTALPatients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
Brimo PS DDS® 50 μg (1 implant)EXPERIMENTALPatients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
ShamSHAM_COMPARATORPatients who received sham in a previous study.

Interventions

NameTypeDescription
Brimo PS DDS®DRUGPatients who received Brimo PS DDS® intravitreal implant in a previous study.
ShamOTHERPatients who recieved sham in a previous study.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason * Applicable studies: Prev...

Countries:United StatesAustraliaCzechiaFranceGermanyIndiaIsraelItalyPhilippinesPortugalSouth KoreaUnited Kingdom
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Frequently asked questions about Brimo PS DDS

What is Brimo PS DDS?

Brimo PS DDS is an investigational small molecule therapy developed by AbbVie Inc. (ticker ABBV) for ophthalmology. It is a posterior segment drug delivery system containing brimonidine tartrate, studied in patients who previously participated in an intravitreal Brimo PS DDS study. It is not approved and remains in clinical development.

What does Brimo PS DDS target?

Brimo PS DDS targets the alpha-2 adrenergic receptors ADRA2A, ADRA2C, and ADRA2B as an agonist. By activating these receptors, it is designed to modulate pathways relevant to retinal health. The drug is delivered to the posterior segment of the eye via an intravitreal delivery system.

Who is developing Brimo PS DDS?

Brimo PS DDS is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is responsible for the clinical program, including the completed Phase 2 safety extension study NCT01080209.

What phase is Brimo PS DDS in?

Brimo PS DDS is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The only listed trial, NCT01080209, is a completed Phase 2 safety extension study.

What clinical trials is Brimo PS DDS in?

Brimo PS DDS has been studied in one completed Phase 2 trial, NCT01080209, titled "Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System." It enrolled 215 patients across the United States, Australia, Czechia, France, Germany, India, Israel, Italy, Philippines, Portugal, South Korea, and the United Kingdom.

Is Brimo PS DDS the same as Brimo PS DDS®?

Yes, Brimo PS DDS and Brimo PS DDS® refer to the same investigational product. The registered trademark symbol is simply a notation of the brand name. Both names are used interchangeably for the brimonidine tartrate posterior segment drug delivery system developed by AbbVie.