Ocular Therapeutix Reports Positive Interim Data From Phase 1 Trial Of OTX-TKI For Wet AMD

Ocular Therapeutix Inc. (OCUL), a biopharmaceutical company focused on eye diseases, announced Tuesday positive interim results from its U.S. Phase 1 clinical trial evaluating OTX-TKI, the axitinib intravitreal hydrogel implant being developed for the treatment of wet age-related macular degeneration or wet AMD and other retinal diseases.

The company said it will discuss future development plans with the FDA and, subject to those discussions, plan to initiate a Phase 2 clinical trial in the third quarter of 2023.

In pre-market activity on Nasdaq, Ocular Therapeutix shares were gaining around 11.4 percent to trade at $5.88.

The interim 7-month data from the trial showed that OTX-TKI was well tolerated and demonstrated a favorable safety profile with no drug-related ocular or systemic serious adverse events or SAEs.

The data will be presented in more detail at the upcoming American Academy of Ophthalmology or AAO 2022 Annual Meeting Subspecialty Day in Chicago on September 30.

wet AMD is a major cause of severe, irreversible vision loss. OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties.

The company noted that the U.S.-based Phase 1 clinical trial is a prospective, multi-center, randomized, controlled study that is evaluating a 600 µg dose of OTX-TKI in a single implant, with a 2 mg aflibercept injection four weeks after the implant. This is compared to 2 mg aflibercept injections administered every 8 weeks in subjects previously treated with anti-VEGF therapy.

The clinical trial enrolled a total of 21 subjects at six clinical sites in the U.S., who were randomized 3:1 to the OTX-TKI arm or the on-label every 8-week aflibercept injection arm.

The trial is assessing the safety, durability and tolerability of OTX-TKI, as well as biological activity in subjects by measuring visual acuity and anatomical changes of the retina using optical coherence tomography.

Antony Mattessich, President and Chief Executive Officer, said, "These interim results from our U.S.-based Phase 1 trial of OTX-TKI for the treatment of wet AMD represent a significant milestone for Ocular. … The data presented today highlights the potential of OTX-TKI to become a highly-differentiated product capable of providing a durable anti-VEGF response that improves upon today's standard of care in the management of wet AMD and with potential in other retinal diseases."

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