On Thursday, Ocular Therapeutix Inc OCUL introduced topline outcomes from the Section 1 HELIOS examine evaluating Axpaxli versus sham management in sufferers with reasonably extreme to extreme non-proliferative diabetic retinopathy with out diabetic macular edema (DME).
6 of 13 (46.2%) sufferers within the Axpaxli group skilled a 1 or 2-step enchancment within the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks, with 2 of the 6 having a 2-step enchancment.
No sufferers within the management group confirmed 1- or 2-step enchancment on the similar time level.
No sufferers within the Axpaxli group skilled any worsening in DRSS. 1 of 8 (12.5%) within the management group skilled worsening within the DRSS at 40 weeks.
A single injection of AXPAXLI supplied sturdy DRSS enchancment as much as 40 weeks.
No sufferers in both arm obtained rescue medicine.
The corporate says the HELIOS outcomes assist the choice to maneuver on to a Section 3 examine with Axpaxli in sufferers with NPDR, pending discussions with the FDA.
Axpaxli was usually properly tolerated, with no irritation noticed, and there was no incidence of iritis, vitritis, or vasculitis.
Earlier this month, Ocular Therapeutix revealed Section 2 information for Paxtrava (travoprost intracameral implant or OTX-TIC) in sufferers with open-angle glaucoma or ocular hypertension.
The information spotlight constant and sustained reductions in Intraocular Stress (IOP), statistically important (p<0.0001) by way of six months, with clinically significant reductions of 24-30% achieved with a single Paxtrava implant.
Value Motion: OCUL shares are down 15.40% at $6.42 on the final test Thursday.
Picture by Amanda Dalbjörn on Unsplash
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