The landscape of retinal disease treatment is evolving with promising results from EyePoint Pharmaceuticals' EYP-1901 clinical development program, showing significant potential in both wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) treatment.
Breakthrough Results in Wet AMD Treatment
The Phase 2 DAVIO-2 study, currently the largest tyrosine kinase inhibitor (TKI) program in wet AMD, has met its primary endpoint of non-inferiority compared to aflibercept. The study enrolled approximately 150 patients across three arms: EYP-1901 high dose, EYP-1901 low dose, and aflibercept control. Following three initial aflibercept loading doses, patients received DURAVYU (EYP-1901) at week eight.
Most notably, about 50% of patients treated with EYP-1901 did not require any supplemental anti-VEGF injections, achieving an impressive 80% reduction in treatment burden while maintaining vision. This significant decrease in injection frequency represents a major quality-of-life improvement for patients managing chronic retinal conditions.
Promising DME Program Developments
The VERONA trial, investigating EYP-1901 in DME patients, has produced encouraging interim results at 16 weeks. The study design included three treatment groups, with patients receiving either high-dose EYP-1901, low-dose EYP-1901, or aflibercept following an initial aflibercept dose on day one.
High-dose EYP-1901 demonstrated superior efficacy, with patients experiencing approximately 6 letters of vision gain compared to aflibercept alone. The treatment also showed substantial reduction in central subfield thickness (CST) and required fewer supplemental aflibercept injections compared to the control arm.
Advancing Phase 3 Studies
The Phase 3 program for wet AMD, comprising the LUGANO and LUCIA trials, is progressing rapidly. The LUGANO study has already enrolled over one-third of its target patient population, exceeding expectations, while the LUCIA trial is also advancing ahead of schedule.
Innovative Mechanism of Action
EYP-1901 combines the bioeriodable Durasert E drug delivery system with voroanib, a small molecule TKI. This approach differs from traditional anti-VEGF treatments by working intracellularly to block receptors. Dr. Ramiro Ribeiro, MD, PhD, emphasizes that EYP-1901 should be viewed as complementary to anti-VEGF therapy rather than a replacement, with the primary goal of maintaining vision while reducing treatment burden.
The DME trial results have particularly highlighted EYP-1901's rapid therapeutic effect, with significant improvements in best-corrected visual acuity (BCVA) observed as early as week four compared to aflibercept alone. This quick onset of action demonstrates the efficient delivery and therapeutic potential of the TKI approach in retinal disease management.
