Piper Sandler analyst Joseph Catanzaro tells investors in a research note that Ocular Therapeutix provided additional data for OTX-TKI as part of its corporate presentation that he thinks points to very favorable early activity, saying the inserts appear to be well-tolerated and predictable with the insert resorbing consistently at 9-10 months. Catanzaro says the update was a very positive early look for OTX-TKI and the hydrogel platform in retinal diseases that could provide significant upside to his current model assumptions. He keeps an Overweight rating and $7 price target on the shares.

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Ocular Therapeutix announced positive topline results from the Phase 1 HELIOS study evaluating AXPAXLI versus a sham control in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema. Ocular plans to present the study results at an upcoming meeting. Summary of Topline Phase 1 HELIOS Results Safety: AXPAXLI was generally well tolerated with no inflammation observed including no incidence of iritis, vitritis or vasculitis. Efficacy Results: 6 of 13 patients in the AXPAXLI group experienced a 1 or 2-step improvement in the Diabetic Retinopathy Severity Scale at 40 weeks, with 2 of the 6 having a 2-step improvement. No patients in the control group showed 1- or 2-step improvement at the same time point. No patients in the AXPAXLI group experienced any worsening in DRSS. 1 of 8 in the control group experienced worsening in the DRSS at 40 weeks. Durability of Effect: A single injection of AXPAXLI provided durable DRSS improvement up to 40 weeks. Rescue medication: No patients in either arm received rescue medication. Next Steps: Positive HELIOS results support decision to move directly to a Phase 3 study with AXPAXLI in patients with NPDR, pending discussions with the FDA. Data Release: Ocular plans to present topline results from the HELIOS study at a future meeting