Ocular Therapeutix (NASDAQ:OCUL) said its eye implant OTX-TKI was seen to be safe and well tolerated in patients as per interim 7-month data from a U.S. phase 1 trial to treat wet age-related macular degeneration (wet AMD).
The company noted that OTX-TKI is an axitinib intravitreal hydrogel implant being developed to treat wet AMD and other retinal diseases. Axitinib is sold as Inlyta by Pfizer (NYSE:PFE).
The phase 1 study is evaluating a 600 µg dose of OTX-TKI in a single implant, with a 2 mg aflibercept [sold as Eylea by Regeneron (REGN) and Bayer (OTCPK:BAYZF) (OTCPK:BAYRY)] injection four weeks after the implant, compared to 2 mg aflibercept injections administered every 8 weeks in patients previously treated with anti-VEGF therapy, Ocular added.
In addition, the company said that OTX-TKI implant showed stable and sustained best corrected visual acuity (BCVA) (mean change from baseline of -1.3 letters) and central subfield thickness at seven months, which was comparable with the aflibercept group dosed every 8 weeks.
Ocular noted that 80% of people were rescue-free up to 6 months and 73% of people were rescue-free up to 7 months after a single OTX-TKI implant injection.
"This adds to our knowledge of the safety and biological activity of a single OTX-TKI implant in a different population of wet AMD than the Australia-based Phase 1 clinical trial where we are studying subjects with uncontrolled subretinal or intraretinal fluid," said Ocular Chief Medical Officer Rabia Gurses.
The company plans to meet with the FDA to discuss potential future clinical trial requirements to start a phase 2 trial in wet AMD in Q3 2023. Ocular also intends to start a U.S.-based phase 1 trial of OTX-TKI to treat diabetic retinopathy in Q1 2023.
Wet AMD is chronic eye disorder which causes blurred vision and can also lead to vision loss.
OCUL +8.90% to $5.75 premarket Sept. 27