Ocular Therapeutix Axpaxli Advances In Phase 3 For Wet AMD, Analyst Forecasts Huge Upside

Core Viewpoint - Needham initiated coverage on Ocular Therapeutix Inc, highlighting the potential of its lead asset, Axpaxli, for treating wet age-related macular degeneration (wet AMD) [1] Group 1: Product Development - Axpaxli is currently under evaluation in two phase 3 trials, with the potential for a product label allowing maintenance treatment every 6 to 12 months, which is a significant improvement over existing treatments that require dosing every 2 to 4 months [2] - The first trial, SOL-1, has completed randomization, with topline results expected in Q4 2025 [3] - The second trial, SOL-R, has enrolled 311 subjects, and the company plans to seek FDA feedback on clinical trial design for Axpaxli in non-proliferative diabetic retinopathy in the first half of 2025 [4] Group 2: Market Potential - The retinal disease market, primarily driven by intravitreally injected anti-VEGFs, is valued at approximately $15 billion [4] - Axpaxli is expected to serve as a second-line treatment for about 40% of the 1.65 million wet AMD patients who do not respond adequately to anti-VEGFs, with peak sales projected around $1.5 billion based on a 15-20% market share of this patient population [5] Group 3: Financial Performance - Ocular Therapeutix reported a fourth-quarter loss of $0.29 per share, compared to a consensus estimate of $0.24, with sales of $17.1 million [6] - The company has a cash balance of $392.1 million, which is expected to fund operations into 2028 without the need for additional capital [6] Group 4: Stock Performance - OCUL stock experienced a rise of 10.10%, reaching $8.42 [7]