OMG! Hehehe!
$Ocular Therapeutix(OCUL.US$ These results are actually really good! ZERO patients in control/placebo group had any improvement! But the actual group! Well here look for yourself! Then keep in mind coming into today there’s almost 12 million shares sold short! With 14 DTC at this volume! Hehehe! but I digress! Hehehe! (((((((((((((. Ocular Therapeutix (NASDAQ:OCUL) announced Thursday that its Phase 1 HELIOS study for retinal disease candidate Axpaxli generated positive results in patients with diabetic retinopathy without diabetic macular edema (DME).
A hydrogel implant comprising a tyrosine kinase inhibitor called axitinib, Axpaxli, was generally well tolerated with no inflammatory indications, the company said, citing topline results from its U.S.-based trial.
The readout represented 21 evaluable subjects who had moderately severe to severe non-proliferative diabetic retinopathy without DME.
HELIOS was designed to evaluate the frequency of treatment-emergent adverse events as its primary endpoint. As for its secondary goal, the Diabetic Retinopathy Severity Scale (DRSS), 46% of subjects in the Axpaxli arm saw 1 or 2-step improvement in DRSS, compared to no such improvement in the control arm.
Zero patients in the Axpaxli group and ~13% in the control group experienced worsening of DRSS. The company expects to discuss HELIOS data with the FDA to advance Axpaxli directly to a Phase 3 trial in NPDR.
A hydrogel implant comprising a tyrosine kinase inhibitor called axitinib, Axpaxli, was generally well tolerated with no inflammatory indications, the company said, citing topline results from its U.S.-based trial.
The readout represented 21 evaluable subjects who had moderately severe to severe non-proliferative diabetic retinopathy without DME.
HELIOS was designed to evaluate the frequency of treatment-emergent adverse events as its primary endpoint. As for its secondary goal, the Diabetic Retinopathy Severity Scale (DRSS), 46% of subjects in the Axpaxli arm saw 1 or 2-step improvement in DRSS, compared to no such improvement in the control arm.
Zero patients in the Axpaxli group and ~13% in the control group experienced worsening of DRSS. The company expects to discuss HELIOS data with the FDA to advance Axpaxli directly to a Phase 3 trial in NPDR.
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