VIDEO: OTX-TKI for NPDR shows promising safety, tolerability at 48 weeks
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In this Healio Video Perspective from the ASRS meeting, Dilsher Dhoot, MD, of California Retina Consultants discusses interim safety and efficacy results for OTX-TKI for the treatment of nonproliferative diabetic retinopathy.
According to Dhoot, patients with moderately severe to severe nonproliferative diabetic retinopathy were randomly assigned 2:1 to receive OTX-TKI (axitinib intravitreal implant, Ocular Therapeutix) or sham and then followed for 52 weeks. The study’s primary endpoint was safety and tolerability, while secondary endpoints included change in Diabetic Retinopathy Severity Scale (DRSS) score, need for rescue therapy, and change in vision and central subfield thickness.
“We saw from the HELIOS phase 1 interim data at 48 weeks that OTX-TKI demonstrated DRSS stability or improvement, with durability through 48 weeks,” Dhoot said. “We saw that none of the OTX-TKI patients developed vision-threatening complications through week 48, and most importantly, we saw that OTX-TKI was well tolerated, with no reported incidence of intraocular inflammation, iritis, vitritis or vasculitis.”
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Dhoot D. Interim safety and efficacy results from the phase 1 HELIOS trial of sustained-release axitinib implant (OTX-TKI) for NPDR. Presented at: American Society of Retina Specialists annual meeting; July 17-20, 2024; Stockholm.
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