DAVIO trial update: 12-month safety results indicate no serious adverse events, reduced treatment burden


Nancy Lurker, CEO of EyePoint Pharmaceuticals, shares the 12-month safety data from the DAVIO trial, investigating EYP-1901 for the treatment of wet age-related macular degeneration (AMD) and nonproliferative diabetic retinopathy.

Video transcript

Hi, I'm Nancy Lurker. I'm the CEO of EyePoint Pharmaceuticals. And this morning here at ASRS in New York City, we just announced our 12-month results from our Phase 1 Davio trial, which is using our EYP-1901 insert, which has an anti-VEGF tyrosine kinase inhibitor in a bioerodable insert designed to last for six months.

Now we did show 12-month data, this is a safety trial, and we showed some very encouraging results with those 12-month data.

Please note, this is really intended to be used for prior treated patients who are now controlled under standard-of-care therapy, and then you insert 1901. And potentially our goal is that every six months, a patient gets a new insert, it bioerodes, you insert another one and that over 50% of patients could be well-controlled with this therapy.

Our results showed that at 12 months, we had a very nice continued reduction in overall treatment burden compared to prior to when these patients entered the trial. And we show that there was a 74% 12-month treatment burden reduction versus 79% at six months, so that continues to be quite impressive. In addition, we showed that 35% of patients got up to 12 months with no need for additional supplemental therapy, despite the implant we know has already run out.

So it's an interesting result that we're seeing, coupled with the fact that we had very strong positive safety results, which showed no serious adverse events now through 12 months, no endophthalmitis, no migration of the insert, no other any type of significant serious adverse events. So it continues to be a very, very safe product.

And this marries up what we're seeing in the commercial space where Yutiq, Iluvien, commercialized by our partner, Alimera, and even Retisert all are using the Durasert platform, and they continue to have very good safety results.

So so far, we're quite pleased with very nice safety with our EYP-1901. But more importantly, this treat-to-maintain paradigm where patients can be treated with standard of care until they're under control—that might take four to six months—then put an EYP-1901 insert on, and hopefully 50% or more can be controlled just on EYP-1901. Some may need an occasional booster or supplement with standard of care, but a substantial reduction in treatment burden that is still quite high.

So of interest is the fact that we are looking forward to initiating our Phase 2 Davio trial in wet AMD and nonproliferative diabetic retinopathy this year, and we hope to have results in about 18 months, so we look forward to continuing to move this product through the pipeline and the potential benefits that can provide to patients.

Note: This transcript has been lightly edited for clarity.

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