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SURF-201

Phase 2

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

SURF-201 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2020

SURF-201 target and mechanism

ModalitySmall molecule

Also known as 0.2% topical corticosteroid solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

SURF-201 clinical trials

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?

SURF-201 is an investigational small molecule eye drop being developed by Harrow, Inc. for post-surgical ocular inflammation. It is a Phase 2 clinical-stage candidate studied in cataract surgery patients in the United States. SURF-201 has not been approved by the FDA and remains in clinical development.

What is SURF-201 used for?

SURF-201 is being studied for post-surgical ocular inflammation following cataract surgery. The Phase 2 trial also enrolled patients with post-surgical ocular pain. It is an investigational therapy and is not approved for any indication.

Who makes SURF-201?

SURF-201 is being developed by Harrow, Inc., which trades on the Nasdaq under the ticker HROW. Harrow is an ophthalmology-focused pharmaceutical company, and SURF-201 is its small molecule eye drop candidate for post-surgical ocular inflammation.

What phase is SURF-201 in?

SURF-201 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program has not been approved by the FDA, so SURF-201 remains an investigational drug in clinical development for post-surgical ocular inflammation.

What clinical trials is SURF-201 in?

SURF-201 has been evaluated in one completed Phase 2 trial, NCT04324359, titled a study of the eye drop SURF-201 in cataract surgery subjects. The trial enrolled 91 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.

How many patients were enrolled in the SURF-201 trial?

The Phase 2 trial of SURF-201, NCT04324359, enrolled 91 participants. It was a randomized, double-blind, placebo-controlled study conducted in the United States in adults aged 18 years and older undergoing cataract surgery, evaluating post-surgical ocular inflammation and post-surgical ocular pain.