Ocular stock rises ~15% as eye drug implant shows promise in ongoing phase 1 trial
Sharamand

Ocular Therapeutix (NASDAQ:OCUL) reported 10-month interim data from a U.S. phase 1 trial of OTX-TKI, an intravitreal hydrogel implant containing axitinib.
Axitinib is a tyrosine kinase inhibitor being developed to treat wet age-related macular degeneration (wet AMD), diabetic retinopathy and other retinal diseases, according to the company
The ongoing phase 1 trial is being undertaken in patients previously treated with anti-VEGF therapy and is evaluating a 600 Âµg dose of OTX-TKI in a single implant, with a 2 mg injection of Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) and Regeneron Pharmaceuticals' (REGN) Eylea (aflibercept) four weeks after the implant, compared to 2 mg aflibercept injections given every 8 weeks.
According to interim data, people treated with a single OTX-TKI implant showed stable and sustained best corrected visual acuity (BCVA) (average change from baseline of -0.3 letters) and central subfield thickness (CSFT) of retina (mean change from baseline of -1.3 Âµm) in the OTX-TKI group at 10 months.
This was comparable with the aflibercept arm (mean change from BCVA baseline of -0.8 letters; mean change from CSFT baseline of -4.5 Âµm).
The company said 73% of patients who were rescue-free up to month 7, continued to show OTX-TKI's extended duration of action and remained rescue-free up to month 10. Overall, a 92% reduction in treatment burden was seen in OTX-TKI treated patients for up to 10 months.
OTX-TKI implant continued to be generally well tolerated with no drug-related ocular or systemic serious adverse events (SAEs) seen in the 10 months.
The company noted that as previously announced at the 7-month readout, one SAE of endophthalmitis was seen in the OTK-TKI group which happened after the aflibercept injection at month 1 and was assessed by the investigator as related to the injection procedure.
Endophthalmitis is a pus containing inflammation of the tissues or fluids inside the eyeball.
"These results demonstrated maintenance of controlled wet AMD subjects for up to 10 months with a single administration of OTX-TKI. We intend to discuss with the FDA future clinical trial requirements and will plan to initiate a first pivotal trial for OTX-TKI in the third quarter of this year, subject to financing including a potential strategic alliance," said President and CEO Antony Mattessich.
Ocular added that there were no elevated IOP, retinal detachment, retinal vasculitis or implant migration into the anterior chamber adverse events seen in the OTX-TKI group.
OCUL +16.54% to $4.51 premarket Feb. 13