Summary

Formal subgroup results from LUGANO have not been published; EyePoint stated that subgroup analyses would be presented at retina meetings beginning with the Retina Society meeting of September 23 to 26, 2026. In the topline data, 9 of 211 participants (4%) in the vorolanib insert arm lost 15 or more letters from causes the sponsor attributed to conditions other than wet AMD: geographic atrophy (6), glaucoma (2), and retinal detachment (1). No aflibercept participants lost vision from such causes. Baseline history of glaucoma in the study eye was 11.4% in the insert arm and 5.9% in the aflibercept arm. Geographic atrophy lesions were closer to the fovea at baseline in the insert arm (825 versus 1,009 microns). Excluding these 9 participants was an ad hoc analysis. The prespecified supplement-free subgroup (113 participants, 54%) met noninferiority (nominal p = 0.0035). The EyePoint chief executive officer stated that visual acuity results were similar in treatment-naive and treatment-experienced participants, but no numerical subgroup results have been released. In DAVIO 2, which enrolled only previously treated participants, EyePoint reported that visual and anatomic outcomes were not meaningfully influenced by baseline visual acuity, duration of wet AMD, or prior treatment burden. These subgroup findings are sponsor-reported, partly post hoc, and not peer reviewed.

LUGANO: participants with vision loss unrelated to wet AMD

“DURAVYU was non-inferior to on-label aflibercept (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (≥ 15 letters) unrelated to wet AMD.” (opens the source at this quote in a new tab)
“In contrast, no patients experienced vision loss (≥ 15 letters) unrelated to wet AMD in the aflibercept control arm.” (opens the source at this quote in a new tab)

LUGANO: causes of vision loss and baseline geographic atrophy location

“Cause of Visual Loss in the 9 Patients: Geographic atrophy (n=6) Glaucoma (n=2) Retinal detachment (n=1)” (opens the source at this quote in a new tab)
“Excluding the cohort, DURAVYU arm gained +3.5 letters” (opens the source at this quote in a new tab)
“In DURAVYU eyes, GA started meaningfully closer to fovea at baseline compared to control, therefore at higher risk of losing vision” (opens the source at this quote in a new tab)

LUGANO: supplement-free subgroup

“Pre-specified analysis of change in BCVA from baseline to average Week 52/56 in supplement-free patients showed that DURAVYU was non-inferior (nominal p-value=0.0035) versus on-label aflibercept” (opens the source at this quote in a new tab)
“The 54% of DURAVYU eyes that were supplement free up to week 56 showed only a 3-micron difference in CST compared to the on-label aflibercept control” (opens the source at this quote in a new tab)

LUGANO: treatment-naive versus previously treated participants

“The results from a visual acuity perspective were similar in both arms. But once again, if you take away those 9 outlier patients, then the results would show noninferiority among all of the dataset.” (opens the source at this quote in a new tab)

LUGANO: planned subgroup presentations

“EyePoint plans to present additional details on the LUGANO dataset, including subgroup-analyses, at major retina conferences in the coming months, beginning at the Retina Society 59 th Annual Scientific Meeting from September 23-26, 2026.” (opens the source at this quote in a new tab)

DAVIO 2: consistency across baseline characteristics in previously treated participants

“Visual and anatomical outcomes were not meaningfully influenced by differences in patient baseline BCVA, duration of wet AMD diagnosis, or historical treatment burden.” (opens the source at this quote in a new tab)

Anti-VEGF comparator context: visual gains by baseline visual acuity

“Stratified by BLVA <23 (n = 382), 23 to <39 (n = 559), 39 to <60 (n = 929), 60 to <74 (n = 994), and ≥74 (n = 515), visual acuity change was 12.6 (20.63), 6.7 (17.88), 3.6 (16.41), 0.3 (13.83), and −3.0 (11.82) letters, respectively.” (opens the source at this quote in a new tab)

Visual acuity loss by choroidal neovascularization lesion subtype: untreated eyes

“Based on these studies, at 12 months 33.2% (95% CI, 19.3%-48.7%) of patients with occult choroidal neovascularization had lost between 3 and 6 lines of VA, compared with 43.7% (95% CI, 28.0%- 60.1%) of patients with classic choroidal neovascularization. This difference was not significant, as reflected by the overlapping CIs.” (opens the source at this quote in a new tab)
“In the 41 treatment arms reporting the location of choroidal neovascularization relative to the fovea, most patients had subfoveal disease (81.4%).” (opens the source at this quote in a new tab)
“We were unable to confirm or refute the commonly held clinical perception that the natural history of visual function is influenced by angiographic choroidal neovascularization subtype.” (opens the source at this quote in a new tab)

Baseline visual acuity and injection intensity: real-world United States eyes

“Greater mean 1-year change in VA also trended with worse baseline VA; those patients with better VA at presentation tended to be particularly vulnerable to vision loss.” (opens the source at this quote in a new tab)
“Specifically, patients with baseline VA of 20/200 or worse, 20/70 to 20/200, 20/40 to 20/70, and 20/40 or better received 6.5, 7.4, 7.5, and 7.3 anti-VEGF injections, respectively, over 1 year.” (opens the source at this quote in a new tab)
“Specifically, those patients with baseline VA of 20/40 or better tended to lose VA at 1 year, regardless of anti-VEGF injection frequency. However, these patients also showed better final VA compared with those patients with worse baseline VA.” (opens the source at this quote in a new tab)
“Mean 1-year change in VA tended to increase in patients with both increased anti-VEGF injection frequency and decreased baseline VA.” (opens the source at this quote in a new tab)

Duravyu (vorolanib intravitreal insert)

Heterogeneity of treatment effect