Our Programs
With an Eye
on the Future™
Our retinal disease–focused pipeline is built to redefine outcomes for patients. When it comes to matters of sight, innovation is our vision.
Addressing the need for reliable, durable retinal therapies
EyePoint aims to redefine the treatment paradigm for serious retinal diseases by creating best-in-class, durable therapies that improve patient outcomes while reducing frequency of follow-up treatments.
| DURASERT E™ PROGRAMS | Indication | Discovery | Pre-Clinical | Phase 1 | Phase 2 | Phase 3 | Next Milestone | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
DURAVYU™ vorolanib intravitreal insert (tyrosine kinase inhibitor) | Wet AMD |
| LUCIA topline data expected in 4Q 2026 | |||||||||||||||||||
DME |
| COMO and CAPRI topline data expected in Q4 2027 | ||||||||||||||||||||
Undisclosed candidates | Retinal Diseases |
| ||||||||||||||||||||
Completed
In Progress
DME=diabetic macular edema; wet AMD=wet age-related macular degeneration
DURAVYU™ (vorolanib intravitreal insert) has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU™ (vorolanib intravitreal insert) is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.
DURAVYU™
DURAVYU™ (vorolanib intravitreal insert in Durasert E™), is being developed as a sustained-delivery treatment for patients suffering from serious retinal diseases, with the potential to provide patients with better visual outcomes with less burden.
DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for DURAVYU™. DURAVYU™ is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.
Description
DURAVYU™ combines vorolanib, a differentiated and patent-protected tyrosine kinase inhibitor (TKI), with Durasert E™, EyePoint’s proprietary next-generation bioerodible matrix.
Vorolanib features a multi-mechanism of action, as it targets VEGF-mediated vascular permeability through the inhibition of all VEGF receptors, and IL-6 mediated inflammation through the inhibition of JAK1 signaling.
Vorolanib has also demonstrated neuroprotection in an in vivo model of retinal detachment1, and inhibits PDGFR, which may provide antifibrotic effect2 – all without inhibiting the TIE2 receptor.
HIGHLIGHTS
- Inhibition of VEGF receptors, PDGF and pro-inflammatory IL-6–mediated signaling3
- Therapeutic levels of vorolanib reached within hours3
- Consistent daily dosing with target inhibition for ≥6 months
- Full elution of vorolanib before matrix bioerosion; no free-floating drug particles
- No cold storage required unlike approved biologics; pre-loaded IVT syringe injector
1. Liu Y, Noda K, Murata M, Wu D, Kanda A, Ishida S. Blockade of Platelet-Derived Growth Factor Signaling Inhibits Choroidal Neovascularization and Subretinal Fibrosis in Mice. J Clin Med. 2020 Jul 15;9(7):2242. doi: 10.3390/jcm9072242. PMID: 32679740; PMCID: PMC7408710.; 2. Howard-Sparks M, Saim S, Farjo R, Paggiarino D, Duker J, Lurker N. Neuroprotective effect of tyrosine kinase inhibitor vorolanib in a mouse model of retinal detachment. Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2829.; 3. Data from preclinical studies. Following a single DURAVYU 900 µg dose in Dutch-Belted rabbits, vorolanib reached concentrations exceeding IC50 in the choroid and retina within hours of administration.
Clinical Trials – EYP-1901
Additional details can be found at www.clinicaltrials.gov
Phase 2 DAVIO 2 Clinical Trial Topline Results (Wet AMD)
A Non-inferiority Trial Evaluating Two Doses of DURAVYU Against an Aflibercept Control in Wet AMD
RESULTS
Nearly two-thirds of eyes treated with DURAVYU were supplement-free up to six months after treatment.
Phase 2 DAVIO 2 Sub-Group Analysis (Wet AMD)
Patients Anti-VEGF Supplement-Free Up to 6 Months
RESULTS
DURAVYU-treated patients had strong and sustained anatomic control vs. aflibercept on-label control patients in supplement-free subgroup.
Phase 2 DAVIO 2 Clinical Trial 12 Month Results (Wet AMD)
A non-inferiority trial versus an aflibercept control
RESULTS
DURAVYU-treated patients had clinically-meaningful supplement-free rates and demonstrated a favorable safety profile through month 12.
Phase 2 VERONA Clinical Trial 24 Week Interim Results (DME)
A randomized, open-label, aflibercept controlled trial in DME
RESULTS
Eyes treated with DURAVYU 2.7mg demonstrated a meaningful and sustained improvement in vision and anatomical control with a continued favorable safety profile.
Phase 3 LUGANO and LUCIA Clinical Trials (Wet AMD)
Global, randomized, double-masked, aflibercept controlled studies designed to enable global regulatory approval of DURAVYU™ (vorolanib intravitreal insert) in wet AMD
OBJECTIVE
Demonstrate DURAVYU, when administered every six months, achieves similar outcomes to on-label aflibercept while reducing treatment burden.
Phase 3 COMO and CAPRI Clinical Trials (DME)
Global, randomized, double-masked, aflibercept controlled studies designed to enable global regulatory approval of DURAVYU™ (vorolanib intravitreal insert) in DME
OBJECTIVE
Demonstrate DURAVYU, when administered every six months, achieves similar outcomes to on-label aflibercept while reducing treatment burden.
Clinical Trials Recruitment
At EyePoint, we are committed to developing therapeutics to improve the lives of patients with serious retinal diseases.
Information regarding our current and previous clinical trials can be found at clinicaltrials.gov. There you can learn more about study participation including eligibility and the risks and benefits of participation as well as gain access to resources that explain more about what it means to participate in a clinical trial.
Anyone interested in involvement with EyePoint clinical trials, please reach out by way of the website or by calling 1-833-EYEPOINT. To learn more about ongoing, EyePoint-sponsored clinical trials, refer to the list below.
Wet AMD (wAMD)
Lugano
A phase 3 study evaluating the efficacy and safety of DURAVYU™ in subjects with wAMD*
Active
Lucia
A phase 3 study evaluating the efficacy and safety of DURAVYU™ in subjects with wAMD*
Active
DAVIO 2
A phase 2 study evaluating the efficacy and safety of DURAVYU™ in subjects with wAMD*
Completed
* Click here for more Information on LUGANO – NCT06668064
* Click here for more Information on LUCIA – NCT06683742
Diabetic Macular Edema (DME)
Verona
A phase 3 study evaluating the efficacy and safety of DURAVYU™ in subjects with DME*
Active
Verona
A phase 3 study evaluating the efficacy and safety of DURAVYU™ in subjects with DME*
Active
Verona
A phase 2 study evaluating the efficacy and safety of DURAVYU™ in subjects with DME
Completed