Ocular Therapeutix™ Reports First Quarter 2025 Results and Business Highlights

Core Insights - Ocular Therapeutix is advancing its AXPAXLI registrational program for wet AMD with a focus on redefining the retina experience and improving long-term outcomes [2][3] - The company received positive FDA feedback for a potential registrational trial design for AXPAXLI in non-proliferative diabetic retinopathy (NPDR) [2][3] - The company reported a cash balance of $349.7 million as of March 31, 2025, which is expected to support operations through 2028 [4] Clinical Trials and Developments - SOL-1 trial for wet AMD is on track for topline data readout in 1Q 2026, with exceptional retention rates and a recent FDA amendment allowing re-dosing at Weeks 52 and 76 [3][14] - SOL-R trial enrollment remains strong, with a reduced target of approximately 555 subjects, and is expected to accelerate trial readout [3][17] - The primary endpoint for SOL-1 is maintaining visual acuity at Week 36, while SOL-R aims to demonstrate non-inferiority in mean BCVA change at Week 56 [16][19] Financial Performance - Total net revenue for Q1 2025 was $10.7 million, a 27.6% decrease from $14.8 million in Q1 2024, primarily due to lower DEXTENZA sales [5][6] - Net product revenue was $10.6 million for Q1 2025, reflecting a 27.7% decrease compared to the same quarter in 2024 [6] - Research and development expenses increased to $42.9 million in Q1 2025, up from $20.7 million in Q1 2024, due to costs associated with clinical trials [8] Market Context - Wet AMD affects approximately 14.5 million individuals globally, with significant challenges in current treatment regimens leading to undertreatment and lack of long-term vision improvement [20][21] - The company aims to address these challenges with AXPAXLI, which is designed to provide a more sustainable therapy with a potential dosing regimen of every 6 to 12 months [2][3]