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GRF312 5%

Phase 2

Dry Eye Disease | Small molecule | Ophthalmology |Grifols, S.A.|Last Updated: Jun 16, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

GRF312 5% · 1 trial · 1 indication

Phase 2 1
NCT07264517Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).Dry Eye Disease
COMPLETED103 Analytics
PHASE2COMPLETED
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).
Dry Eye DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number and proportion of participants with treatment-emergent AEs (TEAEs), serious TEAEs, and TEAEs leading to discontinuation.
Up to Day 84
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group A: GRF312 5% administered b.i.d. (morning/evening)EXPERIMENTAL -
Group B: Vehicle administered b.i.d. (morning/evening)PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
GRF312 5%DRUGImmune Globulin (Human), (GRF312 5% Ophthalmic Solution
Placebo ComparatorOTHERVehicle.
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Eligibility Criteria

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

Inclusion criteria 3. Participant willing and able to self-administer eye drops, follow instructions during the Run-in Period and Treatment Period, and be present for the required visits for the duration of the study. 4\. Participant-reported history of DED in O.U. 5. History of non-prescription (o...

Countries:United States
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Competitive Landscape -Dry Eye Disease 7 trials

Recent Changes (Last 90 Days)

MEDIUMJul 17, 2026NCT07264517TRIAL_REMOVED: changed
MEDIUMJul 17, 2026NCT07264517TRIAL_REMOVED: changed
MEDIUMJul 17, 2026NCT07264517TRIAL_REMOVED: changed
HIGHJun 16, 2026NCT07264517Status: RECRUITING → COMPLETED
HIGHJun 16, 2026NCT07264517Status: RECRUITING → COMPLETED
HIGHJun 16, 2026NCT07264517Status: RECRUITING → COMPLETED

Frequently asked questions about GRF312 5%

What is GRF312 5% used for?

GRF312 5% is an investigational small molecule being developed for the treatment of Dry Eye Disease. It is a topical ophthalmic formulation currently in clinical development, though it is not yet approved by regulatory authorities.

Who makes GRF312 5%?

GRF312 5% is being developed by Grifols, S.A., a biopharmaceutical company traded on the NASDAQ under the ticker GRFS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for Dry Eye Disease.

What phase is GRF312 5% in?

GRF312 5% is in Phase 2 clinical development. A Phase 2 trial has been completed, evaluating the safety, tolerability, and efficacy of the drug in participants with Dry Eye Disease. The drug remains investigational and has not received FDA approval.

What clinical trials is GRF312 5% in?

GRF312 5% has been studied in one completed Phase 2 clinical trial, identified as NCT07264517. This randomized, double-blind, placebo-controlled trial enrolled 103 participants with Dry Eye Disease in the United States, with a minimum age of 18 years.

Is GRF312 5% FDA approved?

GRF312 5% is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Dry Eye Disease. The completed Phase 2 trial assessed its safety and efficacy, but the drug has not yet received regulatory approval for commercial use.