What Is EYP-1901?
EYP-1901 is an investigational drug being studied as an intravitreal injection. It is designed to deliver vorolanib, an active medication, directly into the vitreous humor of the eye. The drug is administered via a single injection through the pars plana using a pre-loaded applicator with a 22-gauge needle. Each EYP-1901 intravitreal (IVT) insert is designed to provide sustained delivery of vorolanib for approximately 6 to 9 months. This sustained-release approach aims to reduce the frequency of injections required for chronic eye conditions, potentially improving patient convenience and adherence compared to more frequent treatments.
Currently, EYP-1901 is under investigation in clinical trials for several serious eye conditions. These include Diabetic Macular Edema (DME), Wet Age-related Macular Degeneration (wAMD), and Nonproliferative Diabetic Retinopathy. A total of 8 trials involving 1,562 participants have been conducted or are ongoing for EYP-1901, sponsored by EyePoint Pharmaceuticals, Inc.
Uses and Conditions Under Study
EYP-1901 is currently being investigated in clinical trials for several retinal diseases. These conditions are characterized by abnormal blood vessel growth or fluid leakage in the eye, which can lead to vision loss.
- Diabetic Macular Edema (DME): This condition is a complication of diabetes, where high blood sugar levels damage blood vessels in the retina, causing fluid to leak into the macula (the central part of the retina responsible for sharp, detailed vision). This leakage leads to swelling and blurred vision. EYP-1901 is being studied to see if its sustained delivery of vorolanib can help reduce this fluid leakage and swelling. A total of 7 trials are investigating EYP-1901 for DME.
- Wet Age-related Macular Degeneration (wAMD): wAMD is a leading cause of vision loss in older adults, characterized by the growth of abnormal, leaky blood vessels under the macula. These vessels can bleed or leak fluid, distorting vision and creating blind spots. EYP-1901 aims to provide a long-acting treatment to inhibit the growth and leakage of these abnormal vessels. EYP-1901 is being studied in 6 trials for wAMD.
- Nonproliferative Diabetic Retinopathy: This is an early stage of diabetic retinopathy where damaged blood vessels in the retina begin to leak, causing swelling and deposits. While vision may not be severely affected initially, NPDR can progress to more severe forms of diabetic retinopathy. EYP-1901 is being investigated in 1 trial to determine if it can help stabilize the retinal blood vessels and prevent progression of the disease.
Overall, clinical trials for EYP-1901 have enrolled 1,562 participants across these conditions, with the earliest trial starting in 2021 and the latest projected to conclude in 2026.
Dosing
EYP-1901 is administered as an intravitreal injection, meaning it is injected directly into the eye. The drug is delivered via a pre-loaded applicator with a 22-gauge needle. The unique design of the EYP-1901 intravitreal (IVT) insert allows for sustained release of the active medication, vorolanib, for an extended period, typically between 6 to 9 months following a single injection.
In clinical trials, various strengths of EYP-1901 have been studied to determine the most effective and safe dose. These investigational strengths range from 440 µg to 3090 µg. Specific dosages include:
- EYP-1901 440 µg (single dose)
- EYP-1901 1343 µg
- EYP-1901 2060 µg (also studied as a single dose)
- EYP-1901 2686 µg
- EYP-1901 3090 µg (also studied as a single dose)
These different dosages are being evaluated across the conditions under study, such as Diabetic Macular Edema and Wet Age-related Macular Degeneration, to optimize treatment outcomes. Other substances like Aflibercept and Sham IVT have been used as comparators in these studies.
Side Effects
In a study of EYP-1901 for wet age-related macular degeneration (wAMD) (NCT05381948), systemic treatment-emergent adverse events (TEAEs) were a frequently reported category. In this trial, 75.0% of patients receiving EYP-1901 3090 mcg experienced systemic TEAEs, compared to 59.6% of patients on EYP-1901 2060 mcg, and 76.9% of patients receiving aflibercept. Study eye TEAEs were reported in 63.8% of patients on EYP-1901 2060 mcg, 57.7% on EYP-1901 3090 mcg, and 57.7% on aflibercept. Fellow eye TEAEs occurred in 23.4% of patients on EYP-1901 2060 mcg, 38.5% on EYP-1901 3090 mcg, and 40.4% on aflibercept. Serious systemic TEAEs were observed in 12.8% of patients on EYP-1901 2060 mcg, 17.3% on EYP-1901 3090 mcg, and 11.5% on aflibercept. Serious study eye TEAEs were reported in 0% of patients on EYP-1901 2060 mcg, 7.7% on EYP-1901 3090 mcg, and 3.8% on aflibercept.
In a separate study of EYP-1901 for nonproliferative diabetic retinopathy (NPDR) (NCT05383209), non-ocular TEAEs were a common category. 61.5% of patients receiving EYP-1901 2060 mcg experienced non-ocular TEAEs, compared to 48.0% of patients on EYP-1901 3090 mcg, and 57.7% of patients receiving sham injection. Study eye TEAEs were reported in 26.9% of patients on EYP-1901 2060 mcg, 44.0% on EYP-1901 3090 mcg, and 26.9% on sham. Non-study eye TEAEs occurred in 30.8% of patients on EYP-1901 2060 mcg, 28.0% on EYP-1901 3090 mcg, and 34.6% on sham. Serious non-ocular TEAEs were observed in 26.9% of patients on EYP-1901 2060 mcg, 4.0% on EYP-1901 3090 mcg, and 7.7% on sham.
Clinical Trial Results
Wet Age-Related Macular Degeneration (wAMD)
Results from a study of EYP-1901 in patients with wet age-related macular degeneration (wAMD) (NCT05381948) compared
Currently Recruiting Trials
EYP-1901 is currently being investigated in two pivotal Phase 3 clinical trials for Diabetic Macular Edema (DME), a serious eye condition that can lead to vision loss. These studies aim to evaluate the efficacy and safety of EYP-1901 compared to an existing treatment, aflibercept. Both trials are double-masked, meaning neither the participants nor the study staff will know which treatment is being administered, helping to ensure unbiased results.
The first study, known as COMO, is a Phase 3 randomized, double-masked trial comparing EYP-1901 against aflibercept in participants with DME. This study, identified as NCT07449936, is sponsored by EyePoint Pharmaceuticals, Inc. It is designed to enroll approximately 240 participants to assess how effectively EYP-1901, at a dosage of 2686 µg, can manage DME symptoms compared to aflibercept.
The second study, named CAPRI, is also a Phase 3 randomized, double-masked trial investigating EYP-1901 versus aflibercept for DME. This trial, NCT07449923, is also sponsored by EyePoint Pharmaceuticals, Inc. Like COMO, the CAPRI study plans to enroll around 240 participants and will evaluate the same dosage of EYP-1901 (2686 µg) against aflibercept to understand its potential benefits for patients living with DME.
Where to Participate
Clinical trials for EYP-1901 are currently recruiting across a wide geographic area, offering opportunities for participation in many communities. There are 73 sites located in 72 cities across 25 states. If you are considering participating, you may find a study site near you.
Top locations with multiple sites include:
- Carmel, Indiana (2 sites)
- San Antonio, Texas (2 sites)
- Sacramento, California (2 sites)
- Phoenix, Arizona (2 sites)
- Redlands, California (2 sites)
- Glendale, California (1 site)
- Encino, California (1 site)
- Scottsdale, Arizona (1 site)
- Poway, California (1 site)
- Mountain View, California (1 site)
Eligibility criteria for these studies specify that participants must be between 18 and 80 years of age. All genders are welcome, but healthy volunteers are not being recruited, and children are not eligible to participate.
Development Timeline
The journey of EYP-1901 began with its first clinical trial on February 10, 2021, driven entirely by EyePoint Pharmaceuticals, Inc. Since then, the development program has expanded significantly, with a total of 8 trials conducted to date, enrolling 1,562 participants across various phases.
Initially, the research focused on conditions such as IBS-C and hyperphosphatemia. However, the pipeline quickly broadened to address significant unmet needs in ophthalmology. This expansion led to investigations for Diabetic Macular Edema (DME), Wet Age-related Macular Degeneration (wAMD), and Nonproliferative Diabetic Retinopathy.
The drug's development has progressed through all clinical phases, starting with 1 Phase 1 trial, moving into 3 Phase 2 trials, and now advancing to 4 Phase 3 trials. This progression demonstrates a commitment to thoroughly evaluating EYP-1901's potential. The latest trial for EYP-1901 is projected to conclude by March 4, 2026, marking a significant milestone in its ongoing development.