Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Vorolanib
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...
Top 16 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
EYP-1901 is an investigational small molecule developed by EyePoint, Inc. for retinal diseases. It is being studied in Phase 3 clinical trials for diabetic macular edema, nonproliferative diabetic retinopathy, and wet age related macular degeneration. It is not yet approved for commercial use.
EYP-1901 targets VEGF receptors. By acting on these receptors, the small molecule is designed to inhibit vascular endothelial growth factor signaling, a pathway involved in the abnormal blood vessel growth and leakage seen in retinal conditions such as diabetic macular edema and wet age related macular degeneration.
EYP-1901 is being developed by EyePoint, Inc., which trades on the Nasdaq under the ticker EYPT. EyePoint is the sponsor of the clinical program evaluating the drug across retinal indications.
EYP-1901 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program includes four trials, two of which are active and not recruiting, with a combined total enrollment of 978 participants across the studies.
EYP-1901 is being evaluated in four Phase 3 trials. The COMO (NCT07449936) and CAPRI (NCT07449923) studies test it against aflibercept in diabetic macular edema. The LUCIA (NCT06683742) and LUGANO (NCT06668064) studies evaluate it in wet age related macular degeneration.
The Phase 3 trials are randomized, double-masked, and active-controlled, comparing EYP-1901 against aflibercept. The COMO and CAPRI studies each enroll 240 patients with diabetic macular edema, while the LUCIA and LUGANO studies each enroll 400 patients with wet age related macular degeneration.