Q&A: Dilsher S. Dhoot, MD, on the HELIOS trial for diabetic retinopathy

Dilsher S. Dhoot, MD, onsite at Retina World Congress 2025 in Fort Lauderdale, Florida.

At the Retina World Congress 2025 in Lauderdale, Florida, Dilsher S. Dhoot, MD, with California Retina Consultants, Retina Consultants of America, in Santa Barbara, California, shared research on the pharmaceutical candidate, OTX-TKI which is being evaluated as a potential treatment for diabetic retinopathy. The presentation focused on the HELIOS trial, which demonstrated promising results for a potential new treatment approach.

The following conversation has been lightly edited for clarity.

Ophthalmology Times: Can you share some insights on your recent work and your presentation at Retina World Congress 2025?

Dilsher S.Dhoot, MD: At Retina World Congress 2025, I have the honor of presenting an update on OTX-TKI for diabetic retinopathy, in particular the HELIOS trial. I had the pleasure of discussing the top line results, namely that OTX-TKI was well-tolerated and safe with no serious adverse events. I also discussed secondary end points, including DRSS improvements. We saw that all DRSS improvements occurred in the OTX-TKI arm and all worsening occurred in the sham arm. We also looked at vision threatening complications, and we saw that all patients with vision threatening complications were in the sham arm, with no patients in the OTX-TKI arm having vision threatening complications.

OT: Can you speak to the analysis of this data?

Dhoot: Now, post-hoc analysis was done, looking specifically at ultrawidefield fluorescing angiography, and we were interested in leakage, and this utilized innovative technology with Justin Sayers and his team from Cole Eye [Institute at Cleveland Clinic], and we were able to measure leakage on fluorescing angiography, and we say that patients with OTX-TKI improved in terms of leakage, compared to those patients in the sham group, who worsened in terms of their leakage. We measured leakage as the total retina, the peripheral retina, and the posterior pole. So this is more compelling data of the action and the biologic activity of OTX-TKI. We look forward to further studies with OTX-TKI in the diabetic retinopathy population.

OT: What do you think the potential of TKIs as a whole hold for the future of ophthalmic treatments?

Dhoot: Tyrosine kinase inhibitors (TKIs) as a class, are really fascinating and intriguing, and I'm very optimistic. In general, the value add here will likely be a durability play. We have a platform where, by TKIs are able to be sustained at levels in the eye with biologic activity for 6 months plus even out to 1 year, snd so these likely be a foundational therapy. In some patients, certainly you'll be supplementing, but hopefully the majority of patients will remain stable, reducing fluctuations in activity and potentially helping with vision.