EyePoint, Inc.: Non-Inferiority Trial Miss Positions the Stock for NT Pressure; Downgrading to Neutral

Research evidence excerpt

J P M O R G A N

North America Equity Research

17 August 2026

EyePoint, Inc.

▼Neutral

Previous: Overweight

Non-Inferiority Trial Miss Positions the Stock for NT

Pressure; Downgrading to Neutral

EYPT, EYPT US

Price (14 Aug 26):$14.75

Earlier this morning, EyePoint announced that the phase 3 LUGANO trial evaluating

Duravyu in wet AMD failed to achieve its primary endpoint of non-inferiority to onlabel aflibercept on BCVA in the full dataset, confounded by an asymmetric cohort

(9/211 patients) who experienced vision loss (≥15 letters) unrelated to wet AMD.

EyePoint believes it is likely that this was “due to chance alone;” in an ad-hoc analysis

that excluded these patients, Duravyu achieved non-inferiority to on-label aflibercept

(nominal p-value=0.0096). In our conversations, there was a broad expectation that

the trial would meet non-inferiority in the overall dataset, so this outcome came as a

surprise and see shares down substantially (approaching cash levels) in the near term.

The Street had been discussing more what would be needed on the secondary

endpoints to excite investors where, notably, the results on the secondary endpoints

appear compelling and at the high end of the scenarios we previously outlined (see

here; e.g., 42% reduction in treatment burden, achieving superiority vs on-label

aflibercept (nominal p-value<0.0001), translating to two fewer injections on average

in Duravyu treated patients vs on-label aflibercept up to 56wk). Additionally, 54% of

Duravyu treated patients were supplement-free up to 56wk (and 79% of patients

received zero or one supplement up to 56wk). On safety, Duravyu was shown to be

safe and well tolerated with repeat dosing in patients. EyePoint plans to present

additional details, including subgroup-analyses, at major conferences in the coming

months, starting with the Retina Society 59th Annual Scientific Meeting (Sept. 2326). Of note, EyePoint expects topline results from the phase 3 LUCIA trial in 4Q26

with a potential NDA submission in 1H27.

SMid Biotechnology

Taking a step back, while we acknowledge that there is some evidence in the overall

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