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Dilsher Dhoot, MD: Analysis of OTX-TKI Implant Shows Promise for Wet AMD Treatment

The data show 80% of patients were rescue-free up to 6 months with a single OTX-TKI implant injection.

At the American Academy of Ophthalmology 2022 Meeting, new data from a 7-month analysis were presented on an axitinib intravitreal implant (OTX-TKI) being evaluated for the treatment of wet age-related macular degeneration (AMD).

The implant is injected via small needle into the eye at a 600 μg dose and is designed to last between six and 9 months and treat patients with wet AMD.

Presenting author Dilsher Dhoot, MD, California Retina Consultants, discussed the analysis In an interview with HCPLive at the conference.

The study evaluated a 600 µg dose of OTX-TKI in a single implant, with a 2 mg aflibercept injection four weeks after the implant, compared to 2 mg aflibercept injections administered every 8 weeks in subjects previously treated with anti-VEGF therapy.

It enrolled a total of 21 subjects at six clinical sites in the U.S., who were randomized 3:1 to the OTX-TKI arm or the on-label every 8-week aflibercept injection arm.

After the administration of OTX-TKI and single aflibercept, Dhoot noted that patients were allowed to be rescued. He noted that the data in the analysis were impressive.

"There were only five rescue injections in four patients, there was actually a 93% reduction in treatment burden," he said. "And we saw that 80% of patients were rescue free at six months, which is very impressive, I think."

With the current anti-VEGF market, Dhoot added that patients are being injected between 8 and 10 weeks. It presents a high burden for patients who may require assistance to get to the office or have to take time off work.

Thus, durability remains a focus in this space to find medications or platforms that result in less trips to the office and less injections.

"This is what really differentiates OTX-TKI potentially," Dhoot said. "Having a medication that lasts up to nine months and maybe even greater, would provide great benefit for our patients."

The year one data on OTX-TKI will be studied next year and Dhoot believes a phase 2 study will follow, as well as investigating other disease states for the platform.

"It is very likely that you would see the typical disease states that are currently being addressed with anti-VEGF, such as diabetic macular edema, potentially diabetic retinopathy, as other areas that are pursued for the OTX-TKI," he said.