Ocular Therapeutix provides 2022 update, reviews 2023 milestones

DEXTENZA 0.4mg: Net product revenue of DEXTENZA for the fourth quarter of 2022 is estimated to be $13.6 million, which would represent growth of approximately 14% over the previous quarter and approximately 11% over the fourth quarter of 2021. DEXTENZA net product revenue for the year is estimated to be $50.2 million, which would represent growth of 20% over 2021. The Company believes DEXTENZA remains poised for continued growth in 2023 with continued drug payment in the ambulatory surgery center setting through the non-opioid pain provision and with a focus on the growing ophthalmic surgery market, more than offsetting the loss of reimbursement in the hospital outpatient department setting. OTX-TKI for wet AMD and other retinal vascular diseases: The Company presented positive interim 6- and 7-month data from its U.S.-based Phase 1 trial of OTX-TKI for the treatment of wet AMD at the American Academy of Ophthalmology 2022 Annual Meeting.Interim data showed a single OTX-TKI implant was generally well tolerated with no drug-related ocular or systemic serious adverse events. 80% of subjects in the OTX-TKI arm were rescue-free up to 6 months and 73% of subjects in the OTX-TKI arm were rescue-free up to 7 months. Subjects treated with a single OTX-TKI implant demonstrated stable and sustained best corrected visual acuity and central subfield foveal thickness at 7 months, which was comparable with the aflibercept arm dosed every 8 weeks. The Company intends to present 9-and 10-month interim data at the upcoming Angiogenesis, Exudation, and Degeneration 2023 Meeting at 8:10 am on Saturday, February 11th, 2023, and plans to follow subjects at least until their respective one-year anniversaries of initial dosing, in accordance with the clinical trial protocol. The Company plans to meet with the FDA in early 2023 to discuss potential future clinical trial requirements with the goal of being in position to initiate a Phase 2/3 clinical trial for the treatment of wet AMD as early as Q3 2023, subject to obtaining additional funding for the trial from external sources, including potentially a strategic alliance. OTX-TKI for the potential treatment of Diabetic Retinopathy: The Company believes that the interim 7-month data from the U.S.-based Phase 1 clinical trial evaluating OTX-TKI for the treatment of wet AMD, as well as the product’s mechanism of action, support proof of concept for the potential treatment of VEGF-mediated retinal vascular diseases, including diabetic retinopathy. The Company initiated a U.S.-based Phase 1 clinical trial for the treatment of DR in December 2022. This trial will include approximately 10 sites and is designed to include approximately 21 patients randomized 2:1 to either a 600 microgram OTX-TKI single implant containing axitinib or sham control. Subject to the results of this trial, discussions with the FDA and additional financing to fund the trial, the Company believes it could be well-positioned to initiate its first Phase 3 pivotal trial for the treatment of DR as early as Q1 2024. OTX-TIC for the treatment of patients with primary open-angle glaucoma or ocular hypertension: The Company continues to enroll its U.S.-based Phase 2 prospective, multi-center, randomized, controlled clinical trial evaluating the safety, tolerability, and efficacy of OTX-TIC for the treatment of patients with primary open-angle glaucoma or ocular hypertension. The trial is designed to evaluate whether OTX-TIC can demonstrate a clinically meaningful decrease in intraocular pressure while preserving endothelial cell health while enabling repeat dosing. Due to observed elevations in intraocular pressure in the OTX-TIC 5 microgram arm of the trial, the Company has decided to terminate enrollment in the 5 microgram arm of the trial and continue forward with the OTX-TIC 26 microgram and Durysta arms of the trial. The Company expects that the Phase 2 clinical trial will consist of approximately 86 patients: approximately 35 patients in the OTX-TIC 26 microgram treatment arm, 35 patients in the Durysta arm and 16 patients that were previously enrolled in the OTX-TIC 5 microgram treatment arm. The Company plans to provide top-line data from the trial in Q4 2023. OTX-DED: The Company continues to advance both dry eye programs and plans to launch a small study in the first half of 2023 to evaluate the performance of OTX-DED versus fast-dissolving collagen plugs and no inserts at all in order to identify a proper placebo control for any future trials of these product candidates. The Company plans to use the results of this study to inform the next steps for both OTX-DED and OTX-CSI.