EYP-1901 in DME: Dante Pieramici, MD, on the COMO and CAPRI phase 3 trials

Vitreoretinal specialist Dante Pieramici, MD, of California Retina Consultants breaks down the phase 3 COMO and CAPRI trials evaluating EYP-1901 (Duravyu), an intravitreal insert redosed every 6 months, against standard-of-care aflibercept in center-involved diabetic macular edema (DME).

The two trials enrolled more than 480 patients in roughly 5 months—ahead of schedule—a pace Pieramici attributes to the persistent burden of frequent anti-VEGF injections and a real-world unmet need in drying out patients with DME. He explains why the non-inferiority design, built around a blended best-corrected visual acuity (BCVA) endpoint at weeks 52 and 56, is effectively a superiority test for treatment frequency, and what the field hopes to learn when 1-year data read out about a year from now.

Pieramici sat down with the Eye Care Network and discussed the growing momentum behind extended drug delivery in retinal disease and the design of the phase 3 COMO and CAPRI trials evaluating EYP-1901 (Duravyu) in diabetic macular edema (DME).

Drawing on 30 years of clinical research experience, Pieramici framed EYP-1901 as a potential non-operative, longer-acting option in a treatment landscape still defined by the burden of frequent intravitreal anti-VEGF injections. COMO and CAPRI are comparing the 2.7-mg dose of the insert, redosed every 6 months, against standard-of-care aflibercept in patients with center-involved DME.

The trials enrolled more than 480 patients across both studies in roughly 5 months—ahead of schedule.¹ Pieramici attributed this rapid recruitment to a persistent unmet need: many patients require frequent injections yet remain incompletely dried out, and diabetic patients in particular are younger, working-aged, and more likely to miss follow-up than patients with neovascular age-related macular degeneration (nAMD). He also credited the trials' broad inclusion of both treatment-naive and previously treated patients, an experienced investigator network carried over from the LUGANO and LUCIA programs, and a design in which every patient receives active therapy rather than observation.

On trial design, Pieramici characterized the studies as testing non-inferiority for visual acuity change while functioning, in practical terms, as superiority trials for treatment frequency—the goal being far fewer injections and a higher proportion of patients requiring no supplemental treatment across each 6-month interval. He described the blended best-corrected visual acuity (BCVA) endpoint at weeks 52 and 56 as reasonable and increasingly conventional, echoing designs used for high-dose aflibercept and faricimab, because it draws conclusions from two time points at differing intervals from the last treatment.

With both trials now fully enrolled, Pieramici said the field looks to readouts approximately a year out to determine whether the every-6-month insert can match standard-of-care outcomes while meaningfully easing the treatment burden that continues to challenge real-world DME care.

References

1. DURAVYU phase 3 DME trials COMO and CAPRI complete enrollment. Modern Retina/Ophthalmology Times. https://www.ophthalmologytimes.com/view/duravyu-phase-3-dme-trials-como-and-capri-complete-enrollment. Accessed August 21, 2026. — Modern Retina