Key Takeaways

  • EyePoint has dosed the first patients in its two phase 3 global trials, COMO and CAPRI, evaluating Duravyu for diabetic macular edema (DME)

  • Duravyu is the only tyrosine kinase inhibitor (TKI) currently in phase 3 trials for DME, offering a sustained 6-month dosing regimen 

  • The pivotal program follows positive phase 2 results and regulatory alignment with the FDA and EMA

EyePoint Pharmaceuticals announced that the first patients have been dosed in both its phase 3 COMO and CAPRI global clinical trials evaluating Duravyu (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME).

Duravyu is an investigational sustained-delivery therapy designed to provide continuous release of vorolanib, a selective tyrosine kinase inhibitor (TKI). The therapy brings a novel, multi-mechanism of action to DME by inhibiting VEGF-mediated vascular permeability, platelet-derived growth factor (PDGF), and IL-6-mediated inflammation.

“Dosing of the first patients in our two pivotal DME trials represents a significant milestone for EyePoint and Duravyu – the only TKI in phase 3 clinical trials for DME–and solidifies our leadership in sustained-release ocular drug delivery,” said Ramiro Ribeiro, MD, PhD, Chief Medical Officer of EyePoint. “Informed by the positive phase 2 VERONA DME results, the efficient trial design of COMO and CAPRI follow an established noninferiority regulatory pathway leveraging the relationships and infrastructure of our exceptionally well-executed pivotal wet AMD program. Together, these trials are designed to position Duravyu with the potential to be the first-in-class and best-in-class TKI for DME, a disease that continues to cause vision loss and significant treatment burden despite available anti-VEGF therapies.”

The Duravyu phase 3 DME program consists of two global, randomized, double-masked, on-label aflibercept-controlled non-inferiority trials (COMO and CAPRI) designed to evaluate the safety and efficacy of Duravyu in both treatment-naïve and previously treated DME patients. Each trial is expected to enroll approximately 240 patients. Participants are randomly assigned on Day 1 to receive either Duravyu 2.7 mg or aflibercept control. Patients in the Duravyu arm will be re-dosed every 6 months beginning on Day 1. The therapy is administered via a single standard intravitreal injection in the physician’s office, consistent with current practice for FDA-approved intravitreal treatments.

The primary endpoint of both trials is noninferior change from baseline in best corrected visual acuity (BCVA) at Weeks 52 and 56, blended, compared with aflibercept control. Secondary endpoints include safety, superiority in reduction of treatment burden, the percentage of eyes free from supplemental aflibercept injections, and anatomical outcomes measured by optical coherence tomography (OCT).

“The current standard of care is overly burdensome for a largely working-age population, and existing therapies do not fully address the underlying disease, as up to two-thirds of DME patients still have active disease after anti-VEGF loading,"  said David Eichenbaum, MD, Principal Investigator in the CAPRI clinical trial and Director of Research for Retina Vitreous Associates. "Duravyu's multi-MOA uniquely targets inflammation through inhibition of IL-6/JAK1 signaling while also reducing vascular leakage through blocking of all VEGF receptors, as indicated by the early and sustained visual and anatomical improvements in the VERONA trial. In addition, Duravyu is designed to provide consistent dosing for at least 6 months, potentially helping to protect vision between visits."

The DME pivotal program follows a positive End-of-Phase 2 meeting with the FDA and reflects alignment with both the FDA and the European Medicines Agency (EMA).