Q&A: Justis P. Ehlers, MD, on the Phase 1 HELIOS NPDR trial
Sydney M Crago
Non-proliferative diabetic retinopathy (NPDR) continues to be an area of focus for pharmaceutical innovations as patients and ophthalmologists hope for better treatment solutions for this condition. Among those treatments currently in development is OTX-TKI, a tyrosine kinase inhibitor from Ocular Therapeutix.
Justis P. Ehlers, MD, spoke to a recent post hoc analysis which looked at the impact of OTX-TKI on macular fluid metrics in patients with NPDR without center-involved diabetic macular edema. For this research, Ehlers served as the director for advanced image analysis.
Ophthalmology Times caught up with Ehlers following the meeting. In this conversation he shared the following answers to our questions on his presentation and the HELIOS trial.
Ophthalmology Times: Can you summarize the key takeaway from the presentation on the HELIOS trial at ARVO?
Justis P. Ehlers, MD: This was a post-hoc analysis of multiple imaging biomarkers from the Phase 1 HELIOS NPDR clinical trial. The key takeaways were that a single OTX-TKI injection provided sustained reduction in intraretinal fluid and quantitative leakage over the course of one year compared to sham.
OT: What is the value in having a treatment that could consistently and continuously maintain fluid for patients with DR?
Ehlers: The biggest advantage is significantly reducing the treatment burden compared to current therapies. The sustained therapeutic response over the course of one year with a single injection provides a potential new opportunity for managing DR with intravitreal pharmacotherapy.
OT: Were there any surprises or unexpected events that were seen in the trial data?
Ehlers: Previous studies have demonstrated that quantitative leakage in DR is a leading indicator of disease progression or waning therapeutic effect. The demonstration of sustained reduction of quantitative leakage on ultra-widefield imaging is an important indicator of persistent therapeutic activity at one year.
OT: What are the next steps for OTX-TKI?
Ehlers: The Phase 3 pivotal programs for OTX-TKI for wet AMD are currently fully enrolled. The next phase clinical trial for DR is currently being planned.
Previously, Ophthalmology Times reported on the HELIOS trial data that were
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