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SURF-201

Phase 2

Post-surgical Ocular Inflammation | Small molecule | Ophthalmology |Harrow, Inc.|Last Updated: Jan 15, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

Clinical trial landscape

SURF-201 · 1 trial · 2 indications

Phase 2 1
NCT04324359Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery SubjectsPost-surgical Ocular Inflammation
COMPLETED91 Analytics
PHASE2COMPLETED
Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects
Post-surgical Ocular InflammationUnlock trial analytics

Study Endpoints

Primary Endpoints

Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0
Day 15

The Investigator used a slit lamp biomicroscope to assess ACCs in the study (surgery) eye. ACC counts were graded as follows: ACC Grade 0 = 0 cells were seen ACC Grade higher than 0 = 1 or more cells were seen

Secondary Endpoints

Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0
Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SURF-201EXPERIMENTAL0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate)
VehiclePLACEBO_COMPARATORTopical preservative-free vehicle (Placebo)

Interventions

NameTypeDescription
SURF-201DRUGOne drop twice daily (BID) in the study eye for 16 days.
PlaceboDRUGOne drop twice daily (BID) in the study eye for 16 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Adult subjects age 18 years or older scheduled for uncomplicated unilateral cataract surgery with posterior chamber intraocular lens (IOL) implantation. 2. Subjects must be able to understand and sign the Informed Consent Form (ICF). 3. Female subjects of childbearing potenti...

Countries:United States
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Frequently asked questions about SURF-201

What is SURF-201 used for?

SURF-201 is an investigational small molecule eye drop being studied for the treatment of post-surgical ocular inflammation and post-surgical ocular pain following cataract surgery. It is in Phase 2 clinical development for these indications.

What does SURF-201 target?

SURF-201 is a small molecule developed for use in ophthalmology. Its specific molecular target has not been disclosed in the available clinical trial information.

Who makes SURF-201?

SURF-201 is being developed by Harrow, Inc., a company traded on the NASDAQ under the ticker symbol HROW.

What phase is SURF-201 in?

SURF-201 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any use.

What clinical trials is SURF-201 in?

SURF-201 has been studied in one completed Phase 2 clinical trial, identified as NCT04324359. This randomized, double-blind, placebo-controlled study enrolled 91 participants in the United States to evaluate the drug's efficacy and side effects in cataract surgery subjects.

Is SURF-201 the same as any other drug?

No alternative names for SURF-201 have been reported in the available clinical trial information. It is identified solely by the name SURF-201.