Ocular Therapeutix Sees Positive Trial Results for OTX-TKI Wet AMD Treatment
September 27 2022 - 6:49AM
Dow Jones News
By Chris Wack
Ocular Therapeutix Inc. said Tuesday it saw positive interim
seven-month data from its U.S. Phase 1 clinical trial evaluating
OTX-TKI, its axitinib intravitreal hydrogel implant being developed
for the treatment of wet age-related macular degeneration and other
retinal diseases.
The biopharmaceutical company said these interim results will
allow it to discuss future development plans with the U.S. Food and
Drug Administration.
If the talks with the FDA go well, Ocular plans to initiate a
Phase 2 clinical trial in the third quarter of 2023.
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 observed. No subjects dropped out
of either arm.
The interim results showed subjects treated with a single
OTX-TKI implant demonstrated stable and sustained best corrected
visual acuity and central subfield thickness at seven months. These
data have not been reviewed by FDA.
The company also plans to follow subjects in the Phase 1 trial
at least until their respective one-year anniversaries of initial
dosing, in accordance with the clinical trial protocol. Given the
potential broad applicability of OTX-TKI to other retina diseases,
Ocular also plans to initiate a U.S.-based Phase 1 clinical trial
to evaluate OTX-TKI for the treatment of diabetic retinopathy in
the first quarter of 2023.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 27, 2022 06:34 ET (10:34 GMT)
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