Recent Updates
Recently added Catalysts

ADX-102

Phase 3

Non-infectious Anterior Uveitis | Small molecule | Ophthalmology |Aldeyra Therapeutics, Inc.|Last Updated: Feb 10, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

ADX-102 · 3 trials · 3 indications

Phase 3 1Phase 2 2
NCT03131154SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.Non-infectious Anterior Uveitis
COMPLETED123 Analytics
PHASE3COMPLETED
SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
Non-infectious Anterior UveitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells
The efficacy assessment period was 4 weeks; baseline was defined as Day 1.

Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to \>0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count \<1 is Grade 0 (absent) and a cell count of \>50 is Grade 4+ (severe).

Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.
Efficacy assessment period (Day 1 through Day 29), Day 29 reported.

Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.

Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.

Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Efficacy assessment period (Day 1 through Day 15), Day 15 reported.

Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ADX-102 Ophthalmic Solution (0.5%)EXPERIMENTAL -
Vehicle of ADX-102 Ophthalmic SolutionPLACEBO_COMPARATOR -
ADX-102 Ophthalmic Solution (0.1%)EXPERIMENTAL -
ADX-102 Ophthalmic Lipid Solution (0.5%)EXPERIMENTAL -
ADX-102 Ophthalmic Drops (0.5%)EXPERIMENTALADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%)EXPERIMENTALADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Vehicle of ADX-102 Ophthalmic DropsPLACEBO_COMPARATORVehicle of ADX-102 Ophthalmic Drops

Interventions

NameTypeDescription
ADX-102 Ophthalmic Solution (0.5%)DRUGADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
Vehicle of ADX-102 Ophthalmic SolutionDRUGVehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
ADX-102 Ophthalmic Solution (0.1%)DRUGADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
ADX-102 Ophthalmic Lipid Solution (0.5%)DRUGADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.
ADX-102 Ophthalmic Drops (0.5%)DRUGADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%)DRUGADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Vehicle of ADX-102 Ophthalmic DropsDRUGVehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Male or female subjects aged ≥ 18 years and ≤ 85 years. * Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks. * Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about ADX-102

What is ADX-102 used for?

ADX-102 is an investigational small molecule being studied for allergic conjunctivitis, dry eye syndromes, and non-infectious anterior uveitis. It is being developed by Aldeyra Therapeutics, Inc. (ALDX) and has completed clinical trials in these indications.

Who makes ADX-102?

ADX-102 is being developed by Aldeyra Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ALDX. The company is conducting clinical research on this investigational small molecule for inflammatory eye conditions.

What phase is ADX-102 in?

ADX-102 is an investigational drug that has completed Phase 2 and Phase 3 clinical trials. It is not FDA approved and remains in clinical development. The most advanced trial was a Phase 3 study in non-infectious anterior uveitis.

What clinical trials is ADX-102 in?

ADX-102 has completed three clinical trials: NCT03012165, a Phase 2 study in allergic conjunctivitis with 154 participants; NCT03131154, a Phase 3 trial in non-infectious anterior uveitis with 123 participants; and NCT03162783, a Phase 2 study in dry eye syndromes with 51 participants.

Is ADX-102 the same as any other drug?

No alternative names for ADX-102 have been disclosed in the available clinical trial information. The drug is referred to solely as ADX-102 in the studies registered on ClinicalTrials.gov.