I'm LongbridgeAI, I can summarize articles.Ocular Therapeutix (OCUL) stock rose 6% as rival EyePoint's Duravyu failed to meet the primary endpoint in its Phase 3 LUGANO trial for wet AMD. While EyePoint cited a confounding subgroup, analysts view the data as validation for the TKI class and reduced regulatory risk for Ocular's Axpaxli. Ocular plans to submit an NDA for Axpaxli in Q4 2026, supported by SOL-1 efficacy data.
Ocular Therapeutix Inc. (NASDAQ:OCUL) stock is trading higher on Monday as the stock reacts to underwhelming data from its rival, EyePoint Inc. (NASDAQ:EYPT).
EyePoint released topline results from its pivotal Phase 3 LUGANO trial. The study evaluated Duravyu for wet age-related macular degeneration, or wet AMD.
The trial showed significant clinical progress on key secondary endpoints. However, it failed to meet its primary visual acuity endpoint. EyePoint attributed the result to a confounding patient subgroup.
Ocular Therapeutix Advances Axpaxli For Wet AMD
Ocular Therapeutix is developing Axpaxli, also known as OTX-TKI, for wet AMD and diabetic retinal disease. The investigational treatment combines a bioresorbable intravitreal hydrogel with axitinib. Axitinib is a small-molecule, multi-target tyrosine kinase inhibitor.
The company is planning to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2026.
The company will support the application with SOL-1 efficacy and safety data. It will also include an interim SOL-R safety analysis of patients who reach Week 52 in the fourth quarter, along with confirmatory evidence.
In its latest quarterly earnings release, Peter Kaiser, Chief Development Officer of Ocular Therapeutix, said, “SOL-1 is the first and only successful superiority trial of a novel agent against an approved anti-VEGF therapy since the class emerged two decades ago.”
Read Also: Ocular's Axpaxli Cuts Risk Of Worsening In Late-Stage AMD Study
Analyst Says EyePoint Data Validate Axpaxli Profile
William Blair on Monday wrote, “Given the totality of the data here, we expect Duravyu would likely be able to be filed on a clean positive readout from LUCIA, though we see greater regulatory risk.”
Analyst Lachlan Hanbury-Brown said the results provide additional validation for the TKI class. However, he said differences in trial design make a direct comparison between Duravyu and Axpaxli difficult.
William Blair also said the positive topline and additional SOL-1 results support Axpaxli’s profile as a durable and effective treatment for nAMD. The firm sees potential in other vascular retinal diseases as well.
The firm said the results also reduce risk around the ongoing SOL-R study, which is expected to read out in the first quarter of 2028, as well as Axpaxli’s potential approval.
OCUL Stock Price Activity: Ocular Therapeutix shares were up 6.32% at $10.81 at the time of publication on Monday, according to Benzinga Pro data.
Image via Shutterstock
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