Business
Ocular Therapeutix™ Reports Third Quarter 2022 Financial Results and Business Update
Announced Positive Interim Data from the U.S.-based Phase 1 Clinical Trial of OTX-TKI for the Treatment of Wet AMD at the American Academy of Ophthalmology
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"\nAnnounced Positive Interim Data from the U.S.-based Phase 1 Clinical Trial of OTX-TKI for the Treatment of Wet AMD at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting\n\nInitiation of OTX-TKI Phase 1 Clinical Trial for the treatment of Diabetic Retinopathy Planned for Q1 of 2023 and Phase 2/3 Clinical Trial for the treatment of Wet AMD Planned for Q3 of 2023\n\nDEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg Recorded Quarterly Net Product Revenue of $11.9 Million\n\nRevised DEXTENZA Annual Net Product Revenue Guidance for 2022 to be between $48 to $52 million, Representing Annual Growth of Approximately 10% to 20%\n\nConference Call to Discuss Third Quarter Results to be Held at 4:30 p.m. ET\n\n BEDFORD, Mass--(BUSINESS WIRE)--\nOcular 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 reported financial results for the quarter ended September 30, 2022, and provided updates on its ophthalmology pipeline.\n\n“We presented arguably the most important clinical data in the Company’s history at this year’s AAO meeting” commented Antony Mattessich, President and CEO. “In the 7-month data from our U.S.-based Phase 1 clinical trial of a 600 µg, single implant OTX-TKI for the treatment of controlled wet AMD, 80% and 73% of subjects were rescue-free up to 6 and 7 months, respectively. In addition to our goal of moving OTX-TKI into a Phase 2/3 trial for the treatment of wet AMD in Q3 of 2023, we also plan to initiate a Phase 1 trial for the treatment of diabetic retinopathy (DR) in Q1 of 2023. Pending good results, and subject to a follow-up meeting with the FDA, we believe we could be in position to initiate our first Phase 3 trial of OTX-TKI for the treatment of DR in Q1 of 2024. On the commercial front, DEXTENZA achieved net revenue of $11.9 million for the quarter despite the continued staffing challenges that we have observed at our ASC and HOPD customers that hindered their ability to operate at full capacity. We believe these challenges are transient in nature and that recent staffing of our sales force at targeted levels and bringing new sales territories online should have a near and long term positive impact on DEXTENZA sales.”\n\nBusiness Updates\n\nOTX-TKI (axitinib i...