On Thursday, Ocular Therapeutix Inc (NASDAQ:OCUL) announced topline results from the Phase 1 HELIOS study evaluating Axpaxli versus sham control in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema (DME).
6 of 13 (46.2%) patients in the Axpaxli group experienced a 1 or 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks, with 2 of the 6 having a 2-step improvement.
No patients in the control group showed 1- or 2-step improvement at the same time point.
No patients in the Axpaxli group experienced any worsening in DRSS. 1 of 8 (12.5%) in the control group experienced worsening in the DRSS at 40 weeks.
A single injection of AXPAXLI provided durable DRSS improvement up to 40 weeks.
No patients in either arm received rescue medication.
The company says the HELIOS results support the decision to move directly to a Phase 3 study with Axpaxli in patients with NPDR, pending discussions with the FDA.
Axpaxli was generally well tolerated, with no inflammation observed, and there was no incidence of iritis, vitritis, or vasculitis.
Earlier this month, Ocular Therapeutix revealed Phase 2 data for Paxtrava (travoprost intracameral implant or OTX-TIC) in patients with open-angle glaucoma or ocular hypertension.
The data highlight consistent and sustained reductions in Intraocular Pressure (IOP), statistically significant (p<0.0001) through six months, with clinically meaningful reductions of 24-30% achieved with a single Paxtrava implant.
Price Action: OCUL shares are down 15.40% at $6.42 at the last check Thursday.
Photo by Amanda Dalbjörn on Unsplash
