EyePoint has entered the final phase of development for its lead product, Duravyu, announcing the completion of patient enrolment for LUGANO, its pivotal Phase III clinical trial. The current wet age-related macular degeneration (wAMD) treatment landscape is largely dominated by vascular endothelial growth factor (VEGF) inhibitors. Duravyu is expected to introduce a novel mechanism of action (MOU), offering enhanced durability and consistent dosing in the wAMD therapeutic arena.
Duravyu is a sustained-release intravitreal implant that selectively inhibits tyrosine kinase activity by targeting all three VEGF receptors: VEGFR-1, VEGFR-2, and VEGFR-3, as well as the platelet-derived growth factor receptor, while sparing the TIE-2 receptor. It is being evaluated in the LUGANO trial, a randomised, active-controlled, quadruple-masked, multicentre Phase III study designed to assess Duravyu’s efficacy, safety, and durability at two dosage levels in patients with wAMD. Enrolment for this trial has been completed across multiple sites in the US.
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Data from the completed Phase II DAVIO2 trial, presented by Dr Katherine Talcott, vitreoretinal surgeon at the Cole Eye Institute, Cleveland Clinic, during the 2025 Association for Research in Vision and Ophthalmology Annual Meeting, demonstrated that both 2mg (n=50) and 3mg (n=52) doses of Duravyu were statistically non-inferior to aflibercept administered every eight weeks (n=54) in terms of improvement in best-corrected visual acuity (BCVA), thereby meeting the primary endpoint. Additionally, BCVA and central subfield thickness were maintained over one year. Remarkably, 63% of eyes treated with Duravyu did not require supplemental aflibercept treatment for up to six months post-insertion. The treatment burden was reduced by 80% among trial participants compared to their pretrial regimen, whereas those previously on standard care experienced a 70% reduction. These findings highlight Duravyu’s potential to significantly alleviate treatment burden while maintaining efficacy and durability, a critical consideration for patients managing wAMD.
Key opinion leaders (KOLs) interviewed by leading data and analytics company GlobalData have praised Duravyu’s initial clinical data, emphasising its promising potential in the wAMD patient population. They noted that Duravyu has demonstrated a level of durability that surpasses many currently approved therapies on the market.
In summary, Duravyu shows considerable promise as a treatment option for wAMD patients and clinicians, given its encouraging efficacy, safety, and durability profiles. Should the LUGANO trial confirm these benefits, Duravyu could emerge as a leading therapy offering much-needed durability in wAMD management.
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