EyePoint Pharmaceuticals (EYPT) Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary

Clinical development progress

• Two pivotal phase III wet AMD trials (LUGANO and LUCIA) fully enrolled over 900 patients in record time, with LUGANO readout expected mid-year and LUCIA a few months later.

• DME program initiated with two 240-patient phase III trials (COMO and CAPRI), first patient dosing expected this quarter, and data anticipated by end of 2027.

• Both wet AMD and DME trials use DURAVYU, a six-month, bio-erodible intravitreal insert, aiming for non-inferiority to aflibercept and reduction in treatment burden.

• Phase II data showed robust efficacy and safety, with two-thirds of patients rescue-free for six months and 50% for a year.

• Patient population in phase III includes 75% newly diagnosed and 25% previously treated, broadening the potential label.

Safety and regulatory strategy

• No safety signals or DURAVYU-related ocular or systemic SAEs observed in over 190 patients in phase II and 900 in phase III to date.

• DSMC reviews have recommended no protocol changes, and redosing studies in animals and humans show no dose-limiting toxicity.

• FDA requires 300 evaluable patients at the go-to-market dose and interval; both LUGANO and LUCIA will provide this, supporting NDA submission with one-year data and sNDA for two-year safety.

• Supplementation criteria in phase III are stricter, with only one main criterion and KOL adjudication for hemorrhage, aiming to reduce unnecessary supplements.

Commercial outlook and manufacturing

• Market opportunity estimated at $12 billion for wet AMD and $3 billion for DME in the U.S., with 25%-40% of wet AMD patients considered candidates for DURAVYU.

• Northbridge, MA manufacturing facility operational, supporting commercial launch and FDA expectations.

• U.S. commercial launch planned with about 70 sales reps and established pre-commercial and medical affairs teams.

• Company expects to be first to file and first to market in the extended TKI space.