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Comparing the new EYP-1901 eye treatment with aflibercept for diabetic macular edema

A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)

PHASE3 · EyePoint Pharmaceuticals, Inc. · NCT07449936

This trial will test whether a single-dose, sustained-release EYP-1901 eye treatment works better than regular aflibercept injections for adults with diabetic macular edema.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorEyePoint Pharmaceuticals, Inc. (industry)
Locations46 sites (Bakersfield, California and 45 other locations)
Trial IDNCT07449936 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-masked phase 3 trial that assigns participants to receive either EYP-1901 or aflibercept (2.0 mg) for diabetic macular edema. Eligible adults may be treatment-naïve or previously treated, with study eye best-corrected visual acuity between 35 and 78 ETDRS letters and prior anti-VEGF treatments allowed if the last dose was at least 12 weeks before screening. The study will compare visual acuity and retinal fluid outcomes between the two groups over the planned follow-up period. Multiple ophthalmology centers in California are participating to enroll patients and perform masked assessments.

Who should consider this trial

Good fit: Adults with diabetic macular edema in one eye, best-corrected visual acuity of 35 to 78 ETDRS letters in the study eye, and who meet the timing criteria for prior anti-VEGF treatment are ideal candidates.

Not a fit: Patients with very poor vision in the fellow eye (BCVA <30 ETDRS letters) or who do not meet the visual acuity or prior-treatment timing criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, EYP-1901 could reduce injection frequency and improve or preserve vision for people with diabetic macular edema.

How similar studies have performed: Earlier-phase studies of EYP-1901 and other sustained-release tyrosine kinase inhibitors have shown encouraging signs for reducing retinal fluid and improving vision, but definitive phase 3 evidence is still pending.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit.
* Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 78 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).
* For previously treated participants: at least 1 injection of anti-VEGF in the past 12 months, the most recent anti-VEGF treatment for DME must not have been administered less than 12 weeks prior to the Screening Visit.

Exclusion Criteria:

* BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.

Where this trial is running

Bakersfield, California and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetic Macular Edema, DME, EyePoint, EYP-1901, Tyrosine Kinase Inhibitor

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.