Ocular Therapeutix Announces 12-Month Topline Data from Ongoing U.S.-Based Phase 1 Clinical Trial Evaluating OTX-TKI for Treatment of Wet AMD

OTX-TKI maintained vision and CSFT comparable to aflibercept every eight weeks, with 89% reduction in treatment burden over a 12-month period

OTX-TKI demonstrated no drug-related ocular or systemic serious adverse events in the trial through Month 12

Implant observed to bioresorb consistently at about eight to nine months in trial, informing potential redosing timeline

Investor/analyst conference call to discuss results to be held on Monday, June 12, at 8:30 a.m. ET

BEDFORD, Mass., June 10, 2023 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye, today announced 12-month data from its Phase 1 U.S. clinical trial evaluating OTX-TKI, the Company’s axitinib intravitreal hydrogel implant, for the treatment of wet age-related macular degeneration (wet AMD). OTX-TKI is also being developed for the treatment of diabetic retinopathy and other retinal diseases.

The data are being presented by Arshad M. Khanani, MD, MA, principal investigator on the trial and Director of Clinical Research at Sierra Eye Associates today at 6:29 p.m. ET (4:29 p.m. MT) at the Clinical Trials at the Summit 2023 Meeting in Park City, Utah. The presentation can be accessed by visiting the scientific and medical presentations tab of the investor section of the Company’s website at www.ocutx.com.

An investigational, bioresorbable hydrogel intravitreal implant, OTX-TKI is designed to continuously deliver a potent tyrosine kinase inhibitor, axitinib, for the treatment of wet AMD and other VEGF-mediated retinal diseases. The 12-month data demonstrated maintenance of controlled wet AMD subjects comparable to aflibercept injections every eight weeks with a single administration of OTX-TKI. Four subjects received rescue therapy for the first time at Month 12, indicating the waning of OTX-TKI’s therapeutic effect and potential disease reactivation, which helps establish a re-dosing timeline for patients. No serious drug-related ocular or systemic adverse events have been observed in the trial.

“We are very pleased to see the durability in the 12-month OTX-TKI data in previously treated patients with wet AMD,” said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. “Pharmacodynamic effects observed in this trial support the characteristics of a treatment for wet AMD with durability between 9 to 12 months with a single injection. Following discussions with the FDA, we have two potential pivotal designs and are prepared to initiate a first pivotal trial for OTX-TKI in wet AMD as early as the third quarter of this year. We are excited for what these data could mean for patients living with VEGF-mediated retinal diseases.”