EyePoint Pharmaceuticals, Inc. has completed patient enrollment for the phase 2 clinical trial assessing EYP-1901 as a potential nine-month treatment for moderate to severe non-proliferative diabetic retinopathy (NPDR).
Talk about EYP-1901.
EYP-1901 is an investigational sustained delivery treatment for retinal disease that incorporates a bioerodible formulation of EyePoint’s proprietary Durasert delivery technology (Durasert E) with vorolanib (a tyrosine kinase inhibitor [TKI]).
What is it being studied to treat?
The small-molecule, anti-vascular endothelial growth factor (VEGF) therapy is in clinical development as a twice-yearly, single-dose intravitreal injection for the following ocular conditions:
NPDR → 9-month maintenance therapy
Wet age-related macular degeneration (AMD) → 6-month maintenance therapy
Diabetic macular edema (DME) → 6-month maintenance therapy
According to EyePoint’s pipeline, EYP-1901 is slated as a potential candidate for dry AMD and geographic atrophy (GA) in 2024.
I need more info on this Durasert technology.
The Durasert platform is designed as a miniaturized, injectable, sustained-delivery system that can provide a stable release of therapeutics within the eye over the course of weeks to months, or even years.
And is there any previous data on EYP-101?
Yup, there is; but not for NPDR ….
The phase 1, prospective, multicenter, dose-escalation, open-label DAVIO trial (NCT04747197) evaluated EYP-1901 at three dose levels (440 µg, 2060 µg and 3090 µg) as a possible six-month treatment for previously treated wet AMD.
Twelve-month data reported a favorable safety and efficacy profile for EYP-1910, with dose-limiting toxicities, ocular serious adverse events (SAEs), or drug-related systemic SAEs, and the potential to maintain the majority of patients for up to 6 months with no supplemental anti-VEGF therapy.
That sounds promising … now talk about this new study.
The multicenter, prospective, double-masked, parallel PAVIA phase 2 study (NCT05383209) is assessing the ocular efficacy and safety of EYP-1901 as a single intravitreal injection compared to sham.
A total of 77 participants (exceeding the original 60-patient goal) are being randomly assigned to receive one of two doses of EYP-1901 (2.06 mg or 3.09 mg) or to a control group to receive a sham injection.
What’s being assessed?
The primary efficacy endpoint is the percentage of patients improving at least two diabetic retinopathy severity scale (DRSS) levels following injections, from baseline to Week 36.
Secondary endpoints are evaluated at baseline, Week 48, and Week 96. They include:
- Reduction of vision-threatening complications due to DR (from baseline, Week 48, Week 96)
- Occurrence of DME and/or proliferative disease
- Retinal ischemia/nonperfusion
- Rates of ocular and nonocular treatment emergent adverse events
When can we expect results?
According to Clinical Trials, the study is expected to be completed in August 2025. Interim data will likely be reported before then though, so stay tuned!