Recent Updates
Recently added Catalysts

ReSure Sealant, Sutures

Phase 3

Cataract Surgery Incision Leak | Unknown | Ophthalmology |Ocular Therapeutix, Inc.|Last Updated: Dec 12, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment488
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01498224ReSure Sealant Pivotal StudyPHASE3 COMPLETED 488 — — Dec 1, 2011Nov 1, 2012Dec 12, 20161 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery.
Days 1-28
Secondary Endpoints
Foreign Body Sensation
Days 1-28
Best corrected visual acuity
Day 1
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SutureACTIVE_COMPARATORSuture application
ReSure SealantEXPERIMENTALSealant application
Interventions
NameTypeDescription
ReSure SealantDEVICEComparison of ReSure Sealant to suture(s)
SuturesPROCEDURE -
Unlock Study Design Details
Eligibility Criteria
Age Range22 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens * Subject must be 22 years of age or older Exclusion Criteria: * Any intraocular inflammation in study eye or prese...

Countries:United States
Unlock Eligibility Criteria