Ocular Therapeutix (OCUL) Piper Sandler 36th Annual Healthcare Conference summary

Company focus and technology

• Recently redefined identity and focus, leveraging a bioresorbable hydrogel technology for retinal therapeutics.

• Aims to address sustainability and long-term visual outcomes in wet macular degeneration.

• Hydrogel delivers a potent TKI, targeting both sustainability and prevention of fibrosis-related vision loss.

Unmet needs and market landscape

• Current anti-VEGF treatments are effective but only reach about 50% of the market due to sustainability issues.

• Many patients lose vision after five years due to fibrosis, not recurrent hemorrhage.

• AXPAXLI offers 9-10 months durability, aiming to surpass biosimilars and existing anti-VEGF therapies.

Clinical trial design and regulatory strategy

• Two phase III trials: SOL-1 (superiority, non-traditional design) and SOL-R (non-inferiority, traditional design).

• SOL-1 avoids sham controls per FDA guidance, with a SPA agreement; SOL-R validated as registrational with a Type C response.

• SOL-1 completed enrollment of over 300 patients ahead of schedule; SOL-R targets 825 patients with seamless patient transfer.