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Diabetic Macular Edema (DME)

5
Pipeline Programs
8
Companies
9
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
150%
Monoclonal Antibody
150%
+ 7 programs with unclassified modality

Competitive Landscape

8 companies ranked by most advanced pipeline stage

ANI Pharmaceuticals
ANI PharmaceuticalsPRINCETON, NJ
1 program
1
ILUVIEN 0.19 MGPhase 41 trial
Active Trials
NCT02424019Completed153Est. Jul 2020
Kodiak Sciences
Kodiak SciencesCA - Palo Alto
1 program
1
Tabirafusp tedromerPhase 31 trial
Active Trials
NCT07734844Recruiting910Est. Sep 2029
Ollin Biosciences
1 program
1
FaricimabPhase 1Monoclonal Antibody1 trial
Active Trials
NCT07484074Completed164Est. Dec 2025
BioTherapeutics Inc
BioTherapeutics IncVA - Blacksburg
1 program
1
LX111 InjectionPhase 11 trial
Active Trials
NCT07362927Recruiting32Est. Sep 2031
Surrozen
SurrozenSOUTH SAN FRANCISCO, CA
1 program
1
SZN-8141 for InjectionPhase 11 trial
Active Trials
NCT07817121Not Yet Recruiting9Est. Aug 2027
Regeneron
RegeneronTARRYTOWN, NY
2 programs
aflibercept 8 mg PFSPHASE_31 trial
Aflibercept 8 mgPHASE_41 trial
Active Trials
NCT05989126Completed35Est. May 2024
NCT06662994Recruiting15Est. Aug 2027
BioCryst Pharmaceuticals
1 program
avoralstatPHASE_1Small Molecule1 trial
Active Trials
NCT07228559Terminated3Est. Apr 2026
Celltrion
CelltrionKorea - Incheon
1 program
CT-P42PHASE_31 trial
Active Trials
NCT04739306Completed348Est. Apr 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
RegeneronAflibercept 8 mg
ANI PharmaceuticalsILUVIEN 0.19 MG
Kodiak SciencesTabirafusp tedromer
Regeneronaflibercept 8 mg PFS
CelltrionCT-P42
SurrozenSZN-8141 for Injection
BioTherapeutics IncLX111 Injection
BioCryst Pharmaceuticalsavoralstat
Ollin BiosciencesFaricimab

Clinical Trials (9)

Total enrollment: 1,669 patients across 9 trials

NCT06662994RegeneronAflibercept 8 mg

High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy

Start: Jul 2025Est. completion: Aug 202715 patients
Phase 4Recruiting
NCT02424019ANI PharmaceuticalsILUVIEN 0.19 MG

Phase 4 IOP Signals Associated With ILUVIEN®

Start: May 2015Est. completion: Jul 2020153 patients
Phase 4Completed
NCT07734844Kodiak SciencesTabirafusp tedromer

A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO

Start: Aug 2026Est. completion: Sep 2029910 patients
Phase 3Recruiting
NCT05989126Regeneronaflibercept 8 mg PFS

Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)

Start: Apr 2024Est. completion: May 202435 patients
Phase 3Completed
NCT04739306CelltrionCT-P42

Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema

Start: Jul 2021Est. completion: Apr 2023348 patients
Phase 3Completed
NCT07817121SurrozenSZN-8141 for Injection

A First-in-human Trial of SZN-8141 in Diabetic Macular Edema

Start: Oct 2026Est. completion: Aug 20279 patients
Phase 1Not Yet Recruiting
NCT07362927BioTherapeutics IncLX111 Injection

Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients

Start: Mar 2026Est. completion: Sep 203132 patients
Phase 1Recruiting
NCT07228559BioCryst Pharmaceuticalsavoralstat

A Study of Avoralstat In Participants With Diabetic Macular Edema

Start: Oct 2025Est. completion: Apr 20263 patients
Phase 1Terminated
NCT07484074Ollin BiosciencesFaricimab

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324

Start: Feb 2025Est. completion: Dec 2025164 patients
Phase 1Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 1,669 patients
8 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.