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Fomivirsen

Phase 2FDA approved

Cytomegalovirus Retinitis | RNA therapy | Infectious Disease |Ionis Pharmaceuticals, Inc.|Trials Updated: Jun 24, 2005

Fomivirsen development status

FDA approval on record Aug 26, 1998 as Vitravene Preservative Free
Approval holderNovartis
ApplicationNDA020961
Highest phase Phase 2

Fomivirsen target and mechanism

Target class-Sen (Aso)
ModalityRNA therapy

Also known as Fomivirsen sodium

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment194

FDA Designations

No designations recorded

Fomivirsen clinical trials

Fomivirsen · 2 trials · 2 indications

Phase 2 2
NCT00002156A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )Cytomegalovirus Retinitis
COMPLETED194 Analytics
NCT00002356The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the EyesCytomegalovirus Retinitis
COMPLETED- Analytics
PHASE2COMPLETED
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
Cytomegalovirus RetinitisUnlock trial analytics
PHASE2COMPLETED
The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
Cytomegalovirus RetinitisUnlock trial analytics

Study Design & Arms

MaskingNONE
PurposeTREATMENT

Interventions

NameTypeDescription
Fomivirsen sodiumDRUG -
GanciclovirDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria Patients must have: * AIDS. * CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy). * No more than one previous progression of CMV retinitis. Exclusion...

Countries:United States
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Frequently asked questions about Fomivirsen

What is fomivirsen used for?

Fomivirsen is an investigational RNA therapy studied for the treatment of cytomegalovirus retinitis, a viral eye infection that occurs in patients with AIDS and other immunocompromised conditions. It was evaluated in Phase 2 clinical trials in patients with CMV of the eyes and HIV infection.

How does fomivirsen work?

Fomivirsen is an antisense oligonucleotide, part of the -sen (ASO) target class. It is designed to bind to viral messenger RNA and block the production of proteins the cytomegalovirus needs to replicate. This antisense mechanism is intended to inhibit CMV replication in the eye.

Who is developing fomivirsen?

Fomivirsen is developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IONS. The company is the sponsor behind the clinical development program for the drug in cytomegalovirus retinitis.

What phase is fomivirsen in?

Fomivirsen is in Phase 2 clinical development. It is an investigational drug and has not been established as approved for commercial use. Two Phase 2 trials have been completed, and no trials are currently active.

What clinical trials is fomivirsen in?

Fomivirsen has been studied in two completed Phase 2 trials. NCT00002356 evaluated the safety and effectiveness of ISIS 2922 in patients with AIDS who have cytomegalovirus of the eyes. NCT00002156 compared intravitreal ISIS 2922 plus ganciclovir versus ganciclovir alone in patients with cytomegalovirus retinitis, enrolling 194 participants.

Is fomivirsen the same as fomivirsen sodium?

Yes, fomivirsen sodium is another name for fomivirsen. The two names refer to the same antisense oligonucleotide drug developed by Ionis Pharmaceuticals for cytomegalovirus retinitis, so readers searching either term are looking at the same asset.