COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eyepoint Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

6 May 2026 → ongoing

Decision date (initial)

2026-04-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

EyePoint Pharmaceuticals, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To evaluate the efficacy of EYP-1901 2686 μg intravitreal (IVT) inserts on best corrected visual acuity (BCVA) changes compared to aflibercept treatment.

Secondary objectives 5

1. 1. To evaluate the efficacy of EYP-1901 IVT inserts on injection burden
2. 2. To evaluate the efficacy of EYP-1901 IVT inserts on changes in retinal thickness
3. 3. To evaluate the efficacy of EYP-1901 IVT inserts on additional BCVA outcomes
4. 4. To evaluate the need for supplemental injection treatment following administration of EYP-1901 IVT inserts
5. 5. To evaluate DME progression following the administration of EYP-1901 IVT inserts

Conditions and MedDRA coding

Diabetic Macular Edema (DME)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Participants will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied. 1. Male or female participants, ≥18 years of age
2. 2. Participants with a diagnosis of diabetes mellitus (DM; Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association. Must have stable DM for a minimum of 3 months prior to the Screening Visit currently managed with use of oral antihyperglycemic agents, insulin, or other injectable drugs.
3. 3. Hemoglobin A1c (HbA1c) <10% at the Screening Visit.
4. 4. Able to understand, and willingness to sign, the informed consent. For US participants only: must be willing to provide access to personal health information via Health Insurance Portability and Accountability Act (HIPAA) authorization.
5. 5. Willingness and ability to comply with all scheduled visits, restrictions, and assessments.
6. 6. For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study.
7. Ocular Inclusion Criteria for Study Eye: 7. Previously diagnosed with macular edema associated with diabetic retinopathy (DR) at any time For the full list of the inclusion criteria please refer to Protocol section 4.1

Exclusion criteria 1

1. Participants who meet any of the following exclusion criteria will be excluded from the study. 1. Ocular Exclusion Criteria for the Study Eye Only 2. Ocular Exclusion Criteria for Either Eye 3. General Exclusion Criteria For the full list of the exclusion criteria please refer to Protocol section 4.2.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint (or outcome) of this study is to find out whether EYP-1901 can produce the same vision benefits as aflibercept over 56 weeks.

Secondary endpoints 6

1. The secondary endpoints (or outcomes) of the study are to find out: • How often injections are needed over the 56 weeks of treatment
2. • Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from the first treatment over time
3. • The percentage of participants who maintain, gain, or lose a certain number of letters on an eye chart over time
4. • The percentage of participants who need additional aflibercept injections up to 88 weeks
5. • The total number of additional aflibercept injections needed by Week 88
6. • The percentage of participants whose DME improves over time and also how quickly DME improves over time

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eyepoint Inc.

Sponsor organisation

Eyepoint Inc.

Address

480 Pleasant Street

City

Watertown

Postcode

02472-2463

Country

United States

Scientific contact point

Organisation

Eyepoint Inc.

Contact name

Medical Affairs

Public contact point

Organisation

Eyepoint Inc.

Contact name

Medical Affairs

Third parties 8

Locations

3 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 77 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications