Recent Updates
Recently added Catalysts

Dorzolamide-timolol

Phase 2

Neovascular Age-related Macular Degeneration | Small molecule | Ophthalmology |Atlantic International Corp.|Last Updated: Jun 19, 2020

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03034772Dorzolamide-timolol in Combination With Anti-vascular Endothelial Growth Factor Injections for Wet Age-related Macular DegenerationPHASE2 COMPLETED 52Feb 8, 2017Jul 5, 2019Jun 19, 20205 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change in Mean Central Subfield Thickness (CST)
Baseline and 18 weeks

Change in mean CST on spectral domain optical coherence tomography from baseline to the final visit

Secondary Endpoints
Change in Mean Maximum Subretinal Fluid (SRF) Height
Baseline and 18 weeks
Change in Mean Maximum Pigment Epithelial Detachment (PED) Height
Baseline and 18 weeks
Change in Visual Acuity
Baseline and 18 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dorzolamide-timololACTIVE_COMPARATORTopical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Artificial tearsPLACEBO_COMPARATORTopical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals.
Interventions
NameTypeDescription
Dorzolamide-timololDRUGTopical eye drop (active comparator) used twice daily for study duration
Artificial tearsOTHERTopical eye drop (placebo comparator) used twice daily for study duration
Unlock Study Design Details
Eligibility Criteria
Age Range45 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Active choroidal neovascularization (CNV) due to AMD. 2. Prior treatment with at least 4 injections of anti-VEGF agents in the past 6 months and persistent intraretinal and/or subretinal fluid on SD-OCT at each visit during this period. 3. Baseline CST ≥ 270 µm on SD-OCT auto...

Countries:United States
Unlock Eligibility Criteria