EYPT: DSMC Review of wAMD Pivotals Continues to Support Clean Safety Profile of Repeat Dosing

研报英文原文证据摘录

EYPT: DSMC Review of wAMD Pivotals Continues to Support Clean Safety Profile of Repeat Dosing

EQUITY RESEARCH QUICK TAKE

RBC Capital Markets, LLC

Lisa Walter, Ph.D. (Analyst)

Luca Issi, Ph.D. (Analyst)

Shelby Hill, Ph.D. (Senior Associate)

Cassie Yuan, Ph.D. (Senior Associate)

May 14, 2026

EyePoint Inc

DSMC Review of wAMD Pivotals Continues to Support Clean Safety Profile of Repeat

Dosing

NASDAQ: EYPT | USD 13.43 | Outperform | Speculative Risk | Price Target USD 37.00

Sentiment: Neutral

The News: EYPT announced that the independent data safety monitoring committee (DSMC) has completed their third and last

review before the top-line results of the ongoing pivotal LUGANO and LUCIA studies in wAMD. As of the May 2nd data cut-off,

all patients have reached their week 32 visit and have received at least 2 doses of Duravyu, and over 35% have received the 3rd

dose, at week 56. The DSMC recommended that both trials continue as planned, with no modifications to the protocol. DSMC

meetings are scheduled biannually as part of the trial protocol (last review cut-off was Sept. 29th, 2025). Top-line results from

LUGANO remain on track for mid-26 (August-ish) with LUCIA to closely follow (~8 weeks later).

Our View: We touched base with the IR team, and they reiterated the DSMC found no safety signals, consistent with previous

trials, and that the safety profile was favorable. We like that the DSMC reviews have been consistent throughout the ongoing

LUGANO/LUCIA trials especially given that we had little safety data around re-dosing of Duravyu, and the DSMC really provides

our first glimpse into the safety profile of re-dosing Duravyu.

For context, from the Phase I and II studies, there have not been any prior safety concerns about EYPT's long-acting TKI (no ocular