FDA Approval for Amendment to SOL-1 Protocol
Received FDA approval for an amendment in SOL-1 to incorporate redosing at weeks 52 and 76, potentially increasing label flexibility to every six to 12 months.
Completion of SOL-1 Randomization
SOL-1 trial completed randomization ahead of schedule in December 2024 with 344 subjects.
Strong Patient Retention in SOL-1
Reported exceptional patient retention in SOL-1, with most rescue treatments aligning with prespecified criteria.
Financial Position and Cash Runway
Cash balance of $392 million as of December 31, 2024, with a cash runway into 2028.
Expansion Opportunities in NPDR and DME
Positive results from the HELIOS trial in NPDR and DME, with FDA feedback on clinical trial design expected in the first half of 2025.