Iveric readies eye drug for FDA following study success

Dive Brief:

• An experimental drug from Iveric Bio helped slow the growth of retinal lesions in people with a form of vision loss known as geographic atrophy, positioning the company to ask for regulatory approval next year.
• After one year, eye lesions of people who received Iveric’s drug were on average about 14% or 18% smaller, depending on the method of measurement, than those who received a placebo. There were no reports of eye inflammation, though more treated study participants had harmful new blood vessels form in their eye, a sign of possible future vision loss.
• Iveric’s drug, called Zimura, is one of two similar treatments in late-stage testing for geographic atrophy. The other, from Apellis Pharmaceuticals, is currently being reviewed by the Food and Drug Administration. Iveric’s drug has now met its goal in two Phase 3 trials, while Apellis’ medicine failed one of two late-stage studies. Iveric’s shares climbed by more than 50% in early trading Tuesday.

Dive Insight:

Geographic atrophy is an irreversible eye disease that results from age-related macular degeneration, where damage to the macula — the part of the eye responsible for central vision — causes progressive vision loss. Once damage occurs, retinal cells can waste away and die, forming the patchy lesions that characterize the disease.

People with the “wet” form of age-related macular degeneration have multiple treatment options that can restore vision. Those with geographic atrophy don’t, meaning they can’t stop the degradation of their vision.

Iveric and Apellis are trying to change that. Both are developing injectable drugs that block activation of the complement system, a part of the body’s innate immune response. They’ve each shown in testing that their drugs appear to slow the growth of the lesions, or scar tissue, that’s found in the eyes of people with geographic atrophy. Iveric’s drug produced a statistically significant reduction in lesion size in two trials, while Apellis’ treatment did so in one of two late-stage studies.

Neither company has proven that slowing lesion growth directly translates to improved vision, though. Apellis, for instance, recently reported that patients in its late-stage trials didn’t experience a visual acuity benefit after two years of treatment. Iveric said it found a “favorable trend” on one measure of vision after a year, but the data wasn’t statistically significant.

Nonetheless, Iveric and Apellis are trying to win approval of their drugs. “We believe the reduction in [geographic atrophy] progression that we have seen [in the two studies] is clinically meaningful and has the potential to alter the natural course of the disease,” said Iveric president Pravin Dugel, on a conference call with analysts on Tuesday.

Iveric’s trial enrolled 448 participants and randomized them to receive monthly eye injections of Zimura or a sham for a year. Patients’ eye lesions were evaluated at the trial’s start, and then again after six and 12 months. Zimura recipients have since been re-randomized to receive drug injections either once monthly or every two months for an additional year.

Analysts at Jefferies were looking for a greater than 25% difference in lesion growth compared to a placebo, citing similar-sized results in Iveric’s other study as well as Apellis’ trials. Iveric didn’t hit that number, though the company pointed to an analysis showing better results — anywhere from a 25% to 32% slowing of lesion growth — in the roughly 40% of patients in the study who were enrolled in the U.S. The company said those patients had smaller lesions at the start of the trial, and claimed Zimura “may have a greater impact on patients who are treated earlier,” Dugel said.

“That’s our hypothesis,” he added. “There’s still a lot of work to be done.”

Iveric will reveal full study results at a medical meeting later this month and plans to file an application with the FDA by the end of the first quarter of 2023.

An approval, if it comes, would give Iveric its first product. The company was once known as Ophthotech, but it rebranded and changed its strategy after a drug it was developing for age-related macular degeneration failed multiple Phase 3 trials.

An FDA decision on Apellis’ drug, meanwhile, is expected by Nov. 26.

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