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Dr. Goldberg shares the topline efficacy, treatment burden, and safety results from the LUGANO trial, highlighting nine outliers who lost vision in the treatment arm.
Posted: 10/07/2026
Dr. Goldberg shares the topline efficacy, treatment burden, and safety results from the LUGANO trial, highlighting nine outliers who lost vision in the treatment arm.
Posted: 10/07/2026
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Hi, I'm Roger Goldberg from Bay Area Retina Associates in Walnut Creek, California, and I'm thrilled to be here at Euretina 2026 in Vienna, Austria. I presented today at the late breaking session the top line results of the LUGANO trial, a phase three trial in wet AMD looking at the bioerodable insert EYP 1901 as a treatment for neovascular or wet AMD. When we look at the top line efficacy results, looking at both visual acuity and anatomy, we see that it actually did not hit non-inferiority to two milligram aflibercept in the full analysis set. And interestingly, this happened despite excellent anatomic control. The CST largely overlaps and performs as well as aflibercept given every eight weeks without that typical seesaw pattern we see with bolus anti-VEGF injections. And at week 56, there was only a four micron difference in the CST between the two treatment arms.
So why do we see this disconnect in the visual acuity results despite good anatomic control of wet macular degeneration? And a post-hoc analysis looked at all of the patients who lost 15 letters of visual acuity or more. And it turns out that nine patients lost visual acuity, significant vision from causes other than wet macular degeneration. And all nine of these cases in this asymmetric cohort were in the EYP 1901 arm. Six had geographic atrophy, two had glaucoma, and one had a retinal detachment. If you exclude those nine patients, we see that the rest of the patients did achieve non-inferiority to the control arm aflibercept. There was only one patient that lost 15 or more letters in the control arm, a rate of 0.5%, which is well below the historic average of a 2Q8 design with aflibercept in wet AMD, which typically is around three to 5%.
What about the reduction in treatment burden? Here we saw great reduction in the treatment burden, 42% at one year. And 80% of patients were able to go a full year with either no or just one supplemental injection. So great results on durability. What about safety? Here again, we saw excellent safety outcomes, no cases of free floating particles, anterior chamber migration or anterior chamber opacities, no cases of occlusive or non-occlusive vasculitis, and no cases of severe intraocular inflammation. So the safety profile looks great. So in summary, in the Lugano study, although it didn't hit the primary endpoint of non-inferiority, this seemed to be driven by nine patients who lost vision, significant vision, 256 letters from causes other than wet macular degeneration. Overall, there was great anatomic control, a significant reduction in the treatment burden and a favorable safety profile. So we look forward to getting the results of LUCIA study in the next couple weeks. Thanks so much.
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