ARVO 2025: LUGANO and LUCIA trial design

At the ARVO 2025 meeting in Salt Lake City, Utah, Nimesh Patel, MD, presented on the LUCIA and LUGANO phase 3 pivotal trials for EYP-1901 against aflibercept for the treatment of wet macular degeneration.

Video Transcript:

Editor's note: The below transcript has been lightly edited for clarity

Nimesh Patel, MD:

Hello there. I'm Nimesh Patel. I'm from Harvard Medical School, Boston Children's Hospital, and Mass Eye and Ear–ophthalmology departments. I'm here presenting the LUCIA and LUGANO phase 3 pivotal trials for EYP-1901, against aflibercept for the treatment of wet macular degeneration.

The medication is a novel, bio-erodible implant that lasts 6 months. It's a tyrosine kinase inhibitor that works intracellularly to inhibit pan-VEGF and VEGFR. One of the benefits of this is it does go away and fully bioerodes. It's 94% medication and only 6% vehicle. It's only one five-thousandth the volume of the eye, so it's very small, and it lasts for up to 6 months. The study that we're doing is we're characterizing this against aflibercept dose every 8 weeks. The trial design is randomized, double masked, global. These are 2 sister studies run in parallel. Both arms, the treatment and the control group have aflibercept started monthly for 3 months. And then in the treatment arm, you get the EYP-1901, medication, and in the treatment arm, you also get a sham injection every 8 weeks. The control group maintains aflibercept every 8 weeks.

The outcomes are at 1 year, with the primary endpoint best corrected visual acuity, with secondary end points being central subfield thickness as well as number of injections and safety.

There are rescue criteria. So if the patient loses a certain amount of letters, or if there's an increase in retinal thickness, there is options to dose patients with aflibercept in the control group as a rescue medication. One of the benefits of this treatment is it's really a paradigm shift in the way we treat wet macular degeneration. This is the first intravitreal injection implant that offers zero-order kinetics and sustained release without a surgical technique. So it offers our patients a point of difference and a possible new treatment for wet macular degeneration. And we're looking forward to the study results. The treatment naive patients are still eligible to be enrolled, and we've already finished enrollment of the previously treated patients.