Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EYP-1901 · 8 trials · 7 indications
BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score change from Baseline to the average of Weeks 52 and 56
Timing of supplemental injection
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Week 36 from baseline.
The BCVA was measured according to the standard procedure originally developed for Early Treatment Diabetic Retinopathy Study (ETDRS). The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population
| Arm | Type | Description |
|---|---|---|
| EYP-1901 2686 µg | EXPERIMENTAL | EYP-1901 |
| Aflibercept | ACTIVE_COMPARATOR | - |
| EYP-1901 1343 µg | EXPERIMENTAL | EYP-1901 1343 µg, single dose |
| EYP-1901 2060 ug | EXPERIMENTAL | EYP-1901 2060 ug; single injection |
| EYP-1901 3090 ug | EXPERIMENTAL | EYP-1901 3090 ug; single injection |
| Sham IVT | SHAM_COMPARATOR | Sham IVT; single injection |
| EYP-1901 2060 mcg | EXPERIMENTAL | EYP-1901 2060 mcg, single dose |
| EYP-1901 3090 mcg | EXPERIMENTAL | EYP-1901 3090 mcg, single dose |
| 440 ug, single dose | EXPERIMENTAL | EYP-1901 440 ug, single dose |
| 2060 ug, single dose | EXPERIMENTAL | EYP-1901 2060 ug, single dose |
| 3090 ug, single dose | EXPERIMENTAL | EYP-1901 3090 ug, single dose |
| Name | Type | Description |
|---|---|---|
| EYP-1901 | DRUG | Intravitreal Injection |
| Aflibercept (2.0 mg) | DRUG | Intravitreal Injection |
| Aflibercept 2Mg/0.05Ml Inj,Oph | DRUG | Intravitreal Injection |
| Sham IVT | OTHER | Sham injections will be used to maintain masking of investigational EYP-1901 therapy for study subjects. |
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 Treatm...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
EYP-1901 is an investigational small molecule being developed for ophthalmology indications including nonproliferative diabetic retinopathy, wet age-related macular degeneration, and diabetic macular edema. It is currently in Phase 3 clinical trials for wet age-related macular degeneration and diabetic macular edema.
EYP-1901 is being developed by EyePoint, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EYPT. The company is conducting Phase 3 clinical trials for this investigational therapy.
EYP-1901 is in Phase 3 clinical development. It is being studied in two Phase 3 trials for diabetic macular edema and one Phase 3 trial for wet age-related macular degeneration. The drug is investigational and not yet approved by regulatory authorities.
EYP-1901 is being evaluated in several clinical trials. NCT06668064 is a Phase 3 study in wet age-related macular degeneration. NCT07449923 and NCT07449936 are Phase 3 trials comparing EYP-1901 against aflibercept in diabetic macular edema. A Phase 2 trial, NCT06099184, has been completed.
No, EYP-1901 is not the same as aflibercept. EYP-1901 is an investigational small molecule being developed by EyePoint, Inc. Aflibercept is a different, approved therapy used as an active comparator in Phase 3 clinical trials of EYP-1901 for diabetic macular edema.