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Fomivirsen

Phase 2

Cytomegalovirus Retinitis | Small molecule | Infectious Disease |Ionis Pharmaceuticals, Inc.|Last Updated: Jun 24, 2005

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment194
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002156A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )PHASE2 COMPLETED 194 - -Jun 24, 200518 United States
NCT00002356The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the EyesPHASE2 COMPLETED - - -Jun 24, 200525 United States
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Study Design & Arms
MaskingNONE
PurposeTREATMENT
Interventions
NameTypeDescription
Fomivirsen sodiumDRUG -
GanciclovirDRUG -
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Eligibility Criteria
Age Range18 Years — 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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