EyePoint (EYPT) investor relations material

Company overview and clinical pipeline

• Focuses on sustained drug delivery for retinal diseases, with lead candidate DURAVYU (EYP-1901), a bioerodible insert delivering vorolanib, targeting VEGF and JAK1 receptors for anti-VEGF and anti-inflammatory effects.

• Phase III trials underway for wet AMD (LUGANO, LUCIA) and DME (COMO, CAPRI), with wet AMD readouts expected in August and DME fully enrolled by Q3 2024; DME top-line data expected Q4 2027.

• Key milestones include multiple phase III readouts and NDA filing over the next 12–18 months.

Differentiation and clinical data

• DURAVYU offers sustained anti-VEGF effect for six months or longer with a single office-based injection, unlike surgical port delivery systems.

• Demonstrates both anti-VEGF and anti-inflammatory activity, potentially leading to better long-term vision and reduced treatment burden.

• Phase II VERONA trial in DME showed rapid and superior vision gains and dryness compared to EYLEA, attributed to JAK1 inhibition and IL-6 pathway modulation.

• DAVIO 2 phase II in wet AMD showed non-inferiority to EYLEA with strong safety and durable anatomic control; about 50% of eyes remained rescue-free at one year.

Phase III trial design and expectations

• Wet AMD phase III trials use a non-inferiority design, enrolling mostly treatment-naïve patients and re-injecting every six months to support a six-month dosing label.

• Primary endpoint is non-inferiority in BCVA; secondary endpoints include safety and reduction in treatment burden, with a target of at least 20% reduction.

• DME trials mirror wet AMD design but dose on day one and include early vision/anatomy endpoints at week four.