#AAO22: Iveric Bio, undeterred by looming PDUFA for competitor, touts subgroup data on GA drug

CHICAGO — While its competitor is on the cusp of likely securing the first FDA nod, Iveric Bio is trudging ahead with its potential treatment for geographic atrophy, an advanced form of AMD, and has new data to support its upcoming NDA filing.

The biotech said its drug was more favorable than sham across all subgroups in the second Phase III study of the investigational complement C5 protein inhibitor, performing similarly to a previous, smaller late-stage trial.

Dubbed avacincaptad pegol, or Zimura (more on that later), the drug beat out sham across patient groups with differing GA disc areas, patients with varying levels of vision clarity based on how many letters they can correctly read, age groups and gender.

Earlier this month, Iveric said the drug met the primary endpoint in the GATHER2 study, reducing the mean rate of GA lesion growth by 14.3%, a p-value of 0.0064. Avacincaptad pegol also cleared the bar in the GATHER1 study last year at a p-value of 0.007. With those two successes, Iveric claims it was the first to do so in GA.

Competitor Apellis, with a Nov. 26 PDUFA date, only succeeded on that prespecified primary goal in one of its two Phase III studies. But 18- and 24-month follow-ups turned the tide in Apellis’ favor, with the reduction rates improving. Both biotechs, within minutes of each other, presented the new data on their GA drugs at the American Academy of Ophthalmology’s annual conference in the Windy City.

Iveric is also collecting data out to 24 months, with half of the patients receiving the drug every month for the first 12 months and then rerandomized to receive it either monthly or every other month to see if benefit can be maintained.

Dhaval Desai

“We don’t really look at the guys ahead of us to say whether it influences one way or another. It just means there either will be someone there or there won’t be someone there,” Dhaval Desai, Iveric development chief and SVP, told Endpoints News Friday morning.

Desai said Iveric thinks it has a unique asset on its hands with a pegylated RNA aptamer “as opposed to a pure biologic play like some of these other compounds out there for geographic atrophy.”

“When aptamers were first in vogue, a big thing around it is they’re small molecules and they have affinity to the target. But the small molecule piece of this, we didn’t really appreciate the potential benefit until recently,” he continued, referring to the GATHER2 topline data from earlier this month.

Iveric believes the safety side is strong, too, with an “extremely clean safety profile,” Desai said. The serious treatment emergent adverse events were higher in the sham group, at 16.7%, than in the Zimura-treated patients, at 13.3%. For both groups, less than 1% of the serious events were ocular-related in the study eye.

GATHER2 was initially supposed to kick off in the early days of 2020, but the Covid-19 pandemic led Iveric to readjust and hold off on enrolling patients until after the first wave of the virus slowed down with the thought that it would lead to fewer patient no-shows. To track how well they did at retaining patients, Iveric observed “injection fidelity” rates, or the number of injections actually delivered over the number of injections expected to be given in the study. The results: 91% for Iveric’s drug and 94% for the sham group.

To help with patient retention, Desai said Iveric gave extra stipends to sites to help arrange car services for patients to get vaccinated.

With the Phase III data from both studies now out in the world, Iveric’s NDA paperwork will be at the FDA’s doorsteps before the end of the first quarter of 2023. Iveric will try to speed up that six-month timeframe, Desai said. The thought is that patients could be on treatment for five, six or more years, Desai said. The mean age of patients on the drug was 76.3 years and 76.7 years for the sham group.

In the meantime, Iveric is focused on bringing everybody up to speed on the need for treatment, how quickly GA lesions can grow and how big of an impact they have on vision, and what the health economic impact is — diminished eyesight, falling, or losing the ability to get behind the wheel.

“I think the community as a whole nor, very frankly, industry really appreciates that very well right now, so those are all the things that not only do we have to educate the community on, but we have to educate ourselves on,” Desai said.

Internally, Iveric also has to decide whether to stick with the name Zimura, which Desai said came to them via Eyetech Pharmaceuticals, well before he or other leaders arrived.

“We’ll see,” he said.

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