Dry Eye Disease

Ophthalmology
29
Pipeline Programs
18
Companies
45
Clinical Trials
6 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
11
0
13
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
1100%
+ 39 programs with unclassified modality

On Market (1)

Approved therapies currently available

U
BROMFENAC SODIUMApproved
bromfenac
Unknown Company
ophthalmic2022

Competitive Landscape

17 companies ranked by most advanced pipeline stage

Bausch + Lomb
Bausch + LombNJ - Bridgewater
8 programs
3
2
2
LotemaxPhase 41 trial
bromfenacPhase 41 trial
Lifitegrast/perfluorohexyloctanePhase 31 trial
NOV03Phase 31 trial
Lifitegrast/Perfluorohexyloctane Fixed Dose CombinationPhase 21 trial
+3 more programs
Active Trials
NCT01650584Completed35Est. Jan 2013
NCT07128628Recruiting423Est. Nov 2026
NCT00758784Completed38Est. Jan 2009
+5 more trials
Alcon
AlconFORT WORTH, TX
9 programs
1
3
0.003% AR-15512Phase 31 trial
0.003% AR-15512 ophthalmic solutionPhase 31 trial
0.003% AR-15512 ophthalmic solutionPhase 31 trial
Hydroxypropyl Guar GalactomannanPhase 21 trial
FID123359 test formulationN/A1 trial
+4 more programs
Active Trials
NCT06571656Terminated73Est. Jul 2025
NCT07238699Not Yet RecruitingEst. Aug 2026
NCT03492541CompletedEst. May 2019
+6 more trials
Sylentis
SylentisSpain - Madrid
3 programs
3
SYL1001 ophthalmic solutionPhase 31 trial
Tivanisiran sodium ophthalmic solutionPhase 31 trial
Tivanisiran sodium ophthalmic solutionPhase 31 trial
Active Trials
NCT03108664CompletedEst. Nov 2018
NCT04819269CompletedEst. Dec 2023
NCT05310422CompletedEst. Oct 2023
AbbVie
AbbVieNORTH CHICAGO, IL
2 programs
1
1
ABBV-444Phase 32 trials
AGN-242428Phase 1/21 trial
Active Trials
NCT04030962Completed292Est. Mar 2022
NCT07284381Recruiting250Est. Nov 2026
NCT05878067Completed40Est. Oct 2023
Stuart Therapeutics
2 programs
1
1
ST-100Phase 31 trial
ST-100 Ophthalmic SolutionPhase 21 trial
Active Trials
NCT05241470CompletedEst. Oct 2021
NCT06178679UnknownEst. Jul 2024
Azura Ophthalmics
Azura OphthalmicsIsrael - Tel Aviv
1 program
1
AZR-MD-001Phase 31 trial
Active Trials
NCT06329791Active Not RecruitingEst. Nov 2025
BRIM Biotechnology
BRIM BiotechnologyTaiwan - Taipei
1 program
1
BRM421 Ophthalmic SolutionPhase 31 trial
Active Trials
NCT05695781CompletedEst. Mar 2024
M&
Merck & Co.RAHWAY, NJ
1 program
1
diquafosol tetrasodiumPhase 35 trials
Active Trials
NCT00403975Completed640Est. Nov 2004
NCT00404131Completed500Est. Dec 2001
NCT00403715Completed500Est. Sep 2002
+2 more trials
S
SantenCA - Emeryville
3 programs
2
DE-101 Ophthalmic SuspensionPhase 21 trial
Diquafosol sodium 3%Phase 21 trial
Artificial tearsN/A1 trial
Active Trials
NCT06298890RecruitingEst. Sep 2027
NCT01468168Completed183Est. Nov 2012
NCT06146881UnknownEst. Mar 2024
Grifols
GrifolsNEW YORK, NY
1 program
1
GRF312 5%Phase 21 trial
Active Trials
NCT07264517RecruitingEst. Nov 2026
Palatin Technologies
1 program
1
PL9643 Ophthalmic SolutionPhase 21 trial
Active Trials
NCT04268069CompletedEst. Oct 2020
Glaukos
GlaukosALISO VIEJO, CA
1 program
1
Pilocarpine Ophthalmic Topical Cream, Dose 1Phase 21 trial
Active Trials
NCT05119920CompletedEst. Jul 2022
O
OculisZUG, Switzerland
1 program
1
licaminlimabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT05896670CompletedEst. Mar 2024
Ipsen
IpsenChina - Tianjin
1 program
1
PalovarotenePhase 11 trial
Active Trials
NCT04762355Completed48Est. Jan 2019
TRB Chemedica International
TRB Chemedica InternationalSwitzerland - Geneva
2 programs
BUFY01 eye drops in single-dose containersN/A1 trial
BUFY02 eye drops in single-dose containersN/A1 trial
Active Trials
NCT05865379RecruitingEst. Jun 2027
NCT05865457RecruitingEst. Jun 2027
Lumenis
LumenisAustralia - Chatswood
2 programs
IPL_RF_MGXN/A1 trial
Protection of eyes with tinted soft scleral eye shieldsN/A1 trial
Active Trials
NCT05487547Completed33Est. Dec 2022
NCT05168670Completed20Est. Jan 2022
Thea Pharma
Thea PharmaMA - Waltham
1 program
Thealoz DuoN/A1 trial
Active Trials
NCT05356728UnknownEst. Dec 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Bausch + Lombbromfenac
Bausch + LombLotemax
AbbVieABBV-444
Bausch + LombLifitegrast/perfluorohexyloctane
Alcon0.003% AR-15512 ophthalmic solution
Alcon0.003% AR-15512 ophthalmic solution
Alcon0.003% AR-15512
Azura OphthalmicsAZR-MD-001
Stuart TherapeuticsST-100
AbbVieABBV-444
BRIM BiotechnologyBRM421 Ophthalmic Solution
SylentisTivanisiran sodium ophthalmic solution
SylentisTivanisiran sodium ophthalmic solution
Bausch + LombNOV03
SylentisSYL1001 ophthalmic solution

Showing 15 of 45 trials with date data

Clinical Trials (45)

Total enrollment: 4,390 patients across 45 trials

Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Start: Aug 2007Est. completion: Aug 200842 patients
Phase 4Completed

Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis

Start: Nov 2006Est. completion: Sep 20075 patients
Phase 4Completed

A Clinical Study to Evaluate the Effect and Side Effect of a New Artificial Tear Formulation (ABBV-444) Compared to Refresh Optive Unit Dose in Adult Participants With Dry Eye Disease

Start: Dec 2025Est. completion: Nov 2026250 patients
Phase 3Recruiting
NCT07111013Bausch + LombLifitegrast/perfluorohexyloctane

A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease

Start: Dec 2025Est. completion: Apr 20270
Phase 3Withdrawn
NCT06660290Alcon0.003% AR-15512 ophthalmic solution

A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

Start: Jan 2025Est. completion: Feb 202555 patients
Phase 3Completed
NCT06544707Alcon0.003% AR-15512 ophthalmic solution

A Study Designed to Evaluate Tear Production

Start: Oct 2024Est. completion: Jan 2025
Phase 3Completed
NCT06544694Alcon0.003% AR-15512

A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease

Start: Oct 2024Est. completion: Mar 202579 patients
Phase 3Completed

A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)

Start: May 2024Est. completion: Nov 2025
Phase 3Active Not Recruiting

Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)

Start: Dec 2023Est. completion: Jul 2024
Phase 3Unknown

A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants

Start: Jun 2023Est. completion: Oct 202340 patients
Phase 3Completed
NCT05695781BRIM BiotechnologyBRM421 Ophthalmic Solution

Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.

Start: Feb 2023Est. completion: Mar 2024
Phase 3Completed
NCT05310422SylentisTivanisiran sodium ophthalmic solution

Safety Study of Tivanisiran to Treat Dry Eye

Start: Mar 2022Est. completion: Oct 2023
Phase 3Completed
NCT04819269SylentisTivanisiran sodium ophthalmic solution

Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

Start: May 2021Est. completion: Dec 2023
Phase 3Completed

Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)

Start: Nov 2020Est. completion: Aug 2021620 patients
Phase 3Completed
NCT03108664SylentisSYL1001 ophthalmic solution

HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)

Start: May 2017Est. completion: Nov 2018
Phase 3Completed
NCT00403975Merck & Co.diquafosol tetrasodium

Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease

Start: Jun 2004Est. completion: Nov 2004640 patients
Phase 3Completed
NCT00404131Merck & Co.diquafosol tetrasodium

Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Start: Mar 2001Est. completion: Dec 2001500 patients
Phase 3Completed
NCT00403715Merck & Co.diquafosol tetrasodium

Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Start: Feb 2001Est. completion: Sep 2002500 patients
Phase 3Completed

Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).

Start: Nov 2025Est. completion: Nov 2026
Phase 2Recruiting
NCT07128628Bausch + LombLifitegrast/Perfluorohexyloctane Fixed Dose Combination

A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease

Start: Oct 2025Est. completion: Nov 2026423 patients
Phase 2Recruiting
NCT05896670Oculislicaminlimab

Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye Disease

Start: Nov 2023Est. completion: Mar 2024
Phase 2Completed
NCT06146881SantenDiquafosol sodium 3%

Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia

Start: Oct 2022Est. completion: Mar 2024
Phase 2Unknown
NCT05119920GlaukosPilocarpine Ophthalmic Topical Cream, Dose 1

Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease

Start: Jan 2022Est. completion: Jul 2022
Phase 2Completed
NCT05241470Stuart TherapeuticsST-100 Ophthalmic Solution

Study of ST-100 as Treatment for Dry Eye Disease

Start: May 2021Est. completion: Oct 2021
Phase 2Completed
NCT04268069Palatin TechnologiesPL9643 Ophthalmic Solution

Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

Start: Feb 2020Est. completion: Oct 2020
Phase 2Completed
NCT01468168SantenDE-101 Ophthalmic Suspension

A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

Start: Oct 2011Est. completion: Nov 2012183 patients
Phase 2Completed
NCT00758784Bausch + Lombbromfenac ophthalmic solution 0.06%

Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

Start: Aug 2008Est. completion: Jan 200938 patients
Phase 2Completed
NCT00760045AlconHydroxypropyl Guar Galactomannan

Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time

Start: Aug 2008
Phase 2Completed
NCT00667004Bausch + Lombecabet ophthalmic solution

Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease

Start: Mar 2008Est. completion: Sep 2008183 patients
Phase 2Completed
NCT00679718Merck & Co.diquafosol tetrasodium

A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

Start: Jan 2000Est. completion: Jul 2000150 patients
Phase 2Completed
NCT00680108Merck & Co.diquafosol tetrasodium

A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution

Start: Sep 1999Est. completion: May 200062 patients
Phase 2Completed

A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease

Start: Mar 2020Est. completion: Mar 2022292 patients
Phase 1/2Completed
NCT04762355IpsenPalovarotene

Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects

Start: Aug 2018Est. completion: Jan 201948 patients
Phase 1Completed
NCT05865379TRB Chemedica InternationalBUFY01 eye drops in single-dose containers

Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease

Start: Mar 2026Est. completion: Jun 2027
N/ARecruiting
NCT07238699AlconFID123440 test formulation

An Evaluation of the Safety and Tolerability of Ocular Lubricants

Start: Mar 2026Est. completion: Aug 2026
N/ANot Yet Recruiting
NCT05865457TRB Chemedica InternationalBUFY02 eye drops in single-dose containers

Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease

Start: Sep 2025Est. completion: Jun 2027
N/ARecruiting
NCT06571656AlconFID123359 test formulation

Evaluation of the Safety and Tolerability of Ocular Lubricants

Start: Apr 2025Est. completion: Jul 202573 patients
N/ATerminated
NCT06298890SantenArtificial tears

The Pattern of Dry Eye Disease After Cataract Surgery

Start: Mar 2024Est. completion: Sep 2027
N/ARecruiting

Feasibility of IPL Combined With RF for Treatment of DED Due to MGD

Start: Jul 2022Est. completion: Dec 202233 patients
N/ACompleted

Comparison of Two Types of Artificial Tears

Start: Mar 2022Est. completion: Dec 2023
N/AUnknown
NCT05168670LumenisProtection of eyes with tinted soft scleral eye shields

Safety of Tinted Soft Scleral Eye Shields When IPL is Applied on Eyelids

Start: Dec 2021Est. completion: Jan 202220 patients
N/ACompleted
NCT05056155AlconSystane Complete

Systane Complete Multi-symptom Relief

Start: Nov 2021Est. completion: Mar 2022119 patients
N/ACompleted
NCT03492541AlconPropylene glycol-based eye drops

Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye Disease

Start: Jul 2018Est. completion: May 2019
N/ACompleted

Evaluation of Ocular Comfort With ISTA Tears vs Systane

Start: Jun 2012Est. completion: Jan 201335 patients
N/ACompleted
NCT01775540AlconSystane Ultra

Systane Ultra Versus Maxidex Versus Saline

Start: May 2012Est. completion: Oct 2012
N/ACompleted

Related Jobs in Ophthalmology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

13 late-stage (Phase 3) programs — potential near-term approvals
6 actively recruiting trials targeting 4,390 patients
18 companies competing in this space