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Brimonidine

Phase 3

Dry Eye | Small molecule | Ophthalmology |Ocugen, Inc.|Last Updated: Jul 18, 2022

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment336
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03785340Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)PHASE3 COMPLETED 252Dec 3, 2018Feb 25, 2019Jul 18, 202216 United States
NCT03418727Dry Eye Disease Study With BrimonidinePHASE2 COMPLETED 84Sep 6, 2017Mar 29, 2018Jul 6, 20223 United States
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Study Endpoints
Primary Endpoints
Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
Baseline, 4 weeks (Day 28)

The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores
Baseline, 4 Weeks (Day 28)

Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.

Tolerance of Test Substance Visual Analogue Scale (VAS) Score
Days 1, 28, 56, and 84

Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).

Secondary Endpoints
Change From Baseline to 2 Weeks (Day 14) in SANDE Score
Baseline, 2 weeks (Day 14)
Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores
Baseline, 2 Weeks (Day 14)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OCU-310EXPERIMENTALBrimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks
PlacebosPLACEBO_COMPARATOROphthalmic buffered saline Eye Drops given 2 times a day for 4 weeks
Study Drug Arm #1EXPERIMENTALCombination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks
Study Drug Arm #2EXPERIMENTALMonotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks
Control ArmPLACEBO_COMPARATORPlacebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks
Interventions
NameTypeDescription
Brimonidine TartrateDRUGBrimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.
PlacebosDRUGOphthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.
BrimonidineDRUGTwo products delivered in sequence twice daily.
Brimonidine Mono TherapyDRUGBrimonidine given twice daily along with placebo drops
sodium carboxymethylcelluloseDRUGPlacebo given twice daily.
Corticosteroid Eye DropDRUGEye drop to be administered after Brimonidine in treatment arm 1
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. Aged 18 years or older. 2. Sign and date informed consent form approved by the IRB 3. History of Dry Eye Disease for ≥6 months 4. Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1): 1. Conjunctival staining at ≥3 (out of a possible ...

Countries:United States
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