Ocular Therapeutix, Inc. (NASDAQ:OCUL) today announced interim 7-month data from its U.S. Phase 1 clinical trial evaluating OTX-TKI, the Company’s axitinib intravitreal hydrogel implant being developed for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. The data will be presented in more detail at the upcoming American Academy of Ophthalmology (AAO) 2022 Annual Meeting Subspecialty Day being held in Chicago by Dilsher Dhoot, MD on Friday, September 30th at 3:29 CT and can be accessed approximately two hours after the presentation’s conclusion for 90 days by visiting the investors section of the Company’s website at investors.ocutx.com.
“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,” said Antony Mattessich, President and Chief Executive Officer. “Wet AMD is a leading cause of blindness affecting approximately 14 million individuals globally and approximately 2 million in the U.S. alone. 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. We look forward to discussing our 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.”
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, compared to 2 mg aflibercept injections administered every 8 weeks in subjects previously treated with anti-VEGF therapy. The trial is designed to assess the safety, durability and tolerability of OTX-TKI, and to assess biological activity in subjects by measuring visual acuity and anatomical changes of the retina using optical coherence tomography. 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.
Based on the data cutoff of August 24, 2022, interim data from the U.S.-based Phase 1 clinical trial showed that the single OTX-TKI implant was generally well tolerated with a favorable safety profile. There were no drug-related ocular or systemic serious adverse events (SAEs) observed. One SAE of endophthalmitis was observed in the OTK-TKI arm which occurred following the mandated aflibercept injection at Month 1 and assessed by the investigator as related to the injection procedure. There were no reported adverse events such as elevated IOP, retinal detachment, retinal vasculitis, or implant migration into the anterior chamber observed in the OTX-TKI arm, and no subjects dropped out of either arm.
