FDA approves second geographic atrophy drug, paving way for Astellas’ Iveric Bio to compete with Apellis

Iveric Bio secured an FDA approval for its geographic atrophy treatment on Friday evening, marking the second drug that’s been cleared for a leading cause of blindness.

The New Jersey drugmaker will launch avacincaptad pegol as Izervay in two to four weeks and set a wholesale acquisition cost of $2,100 per single-dose vial, a spokesperson told Endpoints News.

The nod pads the case for Astellas’ recently completed $5.9 billion acquisition of Iveric and follows a February green light for competitor Apellis, which has run into rare but serious retinal inflammation concerns since launching its drug Syfovre.

Izervay was approved for monthly dosing but its use is capped at 12 months, whereas Apellis’ treatment can be prescribed for dosing once every month or every other month and has no limitations on duration of treatment.

Iveric expects to have 24-month data, including efficacy results on an every-other-month regimen, “a few weeks” after the original Aug. 19 decision date, Iveric president Pravin Dugel told Endpoints in a Friday interview. The biotech hopes the data will warrant longer use of Izervay. “This drug is for life,” Dugel said.

Pravin Dugel

Iveric is a few months behind Apellis in gaining a regulatory OK as its Boston-area competitor has distributed about 68,000 vials to date. Safety will likely be top of mind for retinal specialists looking to choose between the two options, which are the only FDA-approved treatments for the condition that impacts about 1.5 million people in the US.

Apellis has run into safety concerns since launching Syfovre, with reports of rare, but serious inflammation known as retinal vasculitis. Last week, the biotech confirmed seven cases after having reported no such cases in its clinical trials. Iveric said it also experienced no cases of retinal vasculitis across its clinical trials of Izervay.

“We’re happy to be as transparent as possible regarding our safety profile. There’s absolutely no reason to believe that there’s any class effect here whatsoever,” Dugel said.

Both drugs are complement inhibitors and attack different parts of the complement cascade, which contributes to inflammation and is implicated in multiple diseases. Iveric’s treatment goes after the protein C5 and Apellis targets C3. Other biotechs, including gene therapy startup Complement Therapeutics, are emerging to hit different parts of the cascade.

The FDA based its approval of Izervay on two Phase III trials known as GATHER1 and 2. The monthly 2 mg intravitreal drug met the primary endpoint in reducing lesion growth in both studies, showing up to a 35% reduction in disease progression over 12 months. It’s critical to treat patients early because once photoreceptor cells die, they don’t come back and the vision loss can impair everyday activities.

Izervay’s label comes with warnings of endophthalmitis, retinal detachments, neovascular age-related macular degeneration and increase in intraocular pressure.

With an anticipated salesforce of more than 60 people, Iveric is geared up for a quick launch in a field with about 3,000 retina specialists in the US, Dugel said, and its educational campaign also extends to optometrists and ophthalmologists. Iveric hopes to win marketing approval in other regions, like Europe. The globalization strategy was a big reason for linking arms with Astellas, a Japanese pharma with commercialization experience, Dugel said.

The drug almost didn’t make it this far.

Under previous iterations of Iveric, when it was known as Ophthotech, the company had placed more of an emphasis on gene therapy and another asset known as fovista. But that Novartis-partnered drug would end up failing in Phase III. Once Izervay, then known as Zimura, succeeded on the first GATHER study, Iveric wound up funneling more resources to it.

“I don’t know how many in the company honestly thought that it was going to be successful because this company really had evolved into more of a gene therapy company. So it just kept spluttering along until we saw the results of the GATHER1 study,” Dugel said.

therapeutics
gene therapy
biotech
pharma
fda
clinical trials
shares