普通外文研报
Key Takeaways From Our Virtual Ophthalmology Symposium
研报英文原文证据摘录
Key Takeaways From Our Virtual Ophthalmology Symposium
es (referencing injectable complement inhibitors)
has historically been more conservative. The ongoing DRAGON II trial (n=73; US, UK,
and Japan) was designed specifically to enable approval in Japan under Pioneer Drug
Designation, using a 1:1 randomization (vs 2:1 in DRAGON I) for greater statistical power
and a less restrictive visual acuity eligibility cutoff (20/400 vs 20/200 in Dragon I); mgmt noted
enrollment completed quickly, aided by increased patient motivation following DRAGON I's
positive readout. On safety, mgmt emphasized that the two most notable AEs, delayed dark
adaptation and transient xanthopsia (yellow-tinged vision during light/dark transitions), are
mechanistically expected (reflecting temporary slowing of rod-mediated adaptation due to
reduced vitamin A availability), benign, and manageable through patient education, with no
serious ocular treatment-related AEs observed to date. Mgmt also reiterated that the Ph3
PHOENIX trial in GA (n=530) has completed enrollment, with an interim analysis (including
sample size re-estimation) guided to YE26, and voiced optimism regarding the broader
commercial opportunity in GA.
• Epion Therapeutics (private): Epion Therapeutics is developing EpiSmart, a non-invasive,
third-generation corneal cross-linking (CXL) system designed to treat keratoconus without
surgical intervention or epithelial disruption. President/CEO Mike Webb estimates a total
addressable market (TAM) of 3M patients in the U.S., which includes roughly 1M "watch
and wait" keratoconus patients, who are already in the U.S. healthcare system today. This
compares to the ~20k eyes being treated with CXL therapy annually in the domestic market.
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