Diabetic Macular Edema (DME)

5
Pipeline Programs
4
Companies
5
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
1100%
+ 4 programs with unclassified modality

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Regeneron
RegeneronTARRYTOWN, NY
2 programs
1
1
Aflibercept 8 mgPhase 41 trial
aflibercept 8 mg PFSPhase 31 trial
Active Trials
NCT05989126Completed35Est. May 2024
NCT06662994Recruiting15Est. Aug 2027
ANI Pharmaceuticals
1 program
1
ILUVIEN 0.19 MGPhase 41 trial
Active Trials
NCT02424019CompletedEst. Jul 2020
Celltrion
CelltrionKorea - Incheon
1 program
1
CT-P42Phase 31 trial
Active Trials
NCT04739306Completed348Est. Apr 2023
BioCryst Pharmaceuticals
1 program
1
avoralstatPhase 1Small Molecule1 trial
Active Trials
NCT07228559Recruiting9Est. Sep 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
RegeneronAflibercept 8 mg
ANI PharmaceuticalsILUVIEN 0.19 MG
Regeneronaflibercept 8 mg PFS
CelltrionCT-P42
BioCryst Pharmaceuticalsavoralstat

Clinical Trials (5)

Total enrollment: 407 patients across 5 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

Phase 4 IOP Signals Associated With ILUVIEN®

Start: May 2015Est. completion: Jul 2020
Phase 4Completed
NCT05989126Regeneronaflibercept 8 mg PFS

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

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

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

A Study of Avoralstat In Participants With Diabetic Macular Edema

Start: Oct 2025Est. completion: Sep 20269 patients
Phase 1Recruiting

Phase Legend

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

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 407 patients
4 companies competing in this space