Opthea (OPT) Investor Day 2025 summary

Strategic priorities and future plans

• Advancing sozinibrecept as a first-in-class VEGF-C/D inhibitor for wet AMD, aiming for superior vision outcomes in combination with anti-VEGF-A therapies.

• Top-line data from pivotal COAST and SHORE phase 3 trials expected in early and mid-2024 or 2025, with BLA submission planned for the first half of 2026 and potential FDA approval by end of 2026.

• Fast Track designation allows for modular or rolling BLA submissions and potentially faster FDA review.

• Manufacturing scale-up is on track or ahead of plan, with validation batches supporting regulatory filings and launch readiness.

• Building a world-class commercial team with extensive retina product launch experience and robust market research to ensure successful market entry.

Financial guidance and market opportunity

• U.S. wet AMD market estimated at $7 billion, with over 1.2 million treated eyes annually; global opportunity is $12 billion.

• Market is highly concentrated, with 1,400 physicians performing 80% of anti-VEGF injections, enabling a lean commercial footprint.

• Buy-and-bill reimbursement model offers economic favorability for combination therapy, with Medicare covering over 90% of patients.

• Payers expect pricing at parity with branded anti-VEGF-A therapies and seek at least a 20% improvement in vision outcomes for broad coverage.

• Additional funding may be required before commercialization to meet obligations and support launch activities.

Clinical development and differentiation

• Sozinibrecept demonstrated statistical superiority in phase 2B when combined with standard of care, with robust safety profile and no increased ocular adverse events.

• Phase 3 trials (COAST and SHORE) enrolled 1,984 patients across 33 countries, are large, global, and designed as superiority trials targeting all-comer and key subpopulations.

• Primary endpoints at week 52, with two-year follow-up; trials powered at 90% to detect differences between arms.

• Combination therapy aims to address persistent disease activity and improve absolute vision gains, a key unmet need not addressed by current anti-VEGF-A monotherapies.

• Phase 2B data show over 30% improvement in visual acuity over ranibizumab monotherapy and a 42% relative increase in patients achieving 20/40 vision in key subpopulations.