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    AXPAXLI NDA Acceleration Might Change The Case For Investing In Ocular Therapeutix (OCUL)

    Simply Wall St·12/07/2025 17:15:23
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    • In late 2025, Ocular Therapeutix announced it plans to submit a new drug application for its wet age-related macular degeneration therapy AXPAXLI based on year 1 data from the SOL-1 Phase 3 trial, following updated interactions with the FDA that may allow reliance on a single pivotal study.
    • This shift to an earlier filing, alongside progressing Phase 3 programs in non-proliferative diabetic retinopathy and other ELUTYX-based assets, could materially reshape Ocular’s development timelines and competitive position in retinal diseases.
    • Next, we’ll examine how this accelerated AXPAXLI filing plan could reshape Ocular Therapeutix’s investment narrative and long-term growth profile.

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    Ocular Therapeutix Investment Narrative Recap

    To own Ocular Therapeutix, you need to believe AXPAXLI can become a meaningful new option in retinal disease and eventually justify today’s rich sales multiple despite ongoing losses. The updated plan to file for wet AMD based on year 1 SOL-1 data sharpens the near term focus on that single readout as the key catalyst, while also increasing sensitivity to any unexpected efficacy or safety issues in 2026.

    Among recent updates, the launch of the HELIOS-3 Phase 3 program in non proliferative diabetic retinopathy stands out, because it reinforces AXPAXLI’s potential beyond wet AMD at the same time the NDA pathway may be accelerating. Together, the earlier filing plan and NPDR expansion concentrate both upside and downside around execution quality across AXPAXLI’s Phase 3 trials and Ocular’s ability to fund these programs without overly diluting shareholders.

    Yet investors should also be aware that if SOL-1 year 1 data disappoints, Ocular’s reliance on AXPAXLI could...

    Read the full narrative on Ocular Therapeutix (it's free!)

    Ocular Therapeutix's narrative projects $192.9 million revenue and $44.8 million earnings by 2028.

    Uncover how Ocular Therapeutix's forecasts yield a $22.92 fair value, a 82% upside to its current price.

    Exploring Other Perspectives

    OCUL Community Fair Values as at Dec 2025
    OCUL Community Fair Values as at Dec 2025

    Three members of the Simply Wall St Community currently estimate Ocular’s fair value between US$5.02 and US$27.35, showing a wide spread of views. You can weigh those against the fact that Ocular is still unprofitable with high R&D needs and no clear timeline to positive earnings, which has important implications for dilution risk and long term returns.

    Explore 3 other fair value estimates on Ocular Therapeutix - why the stock might be worth less than half the current price!

    Build Your Own Ocular Therapeutix Narrative

    Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

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    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.