Chris Simms

Chris Simms is senior VP and chief commercial officer of Iveric Bio, a biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. Mr. Simms has more than 20 years’ experience as a healthcare leader, with previous leadership positions at companies including Johnson & Johnson, Genentech and Novartis.

Ophthalmology Management: Iveric Bio’s Zimura is currently in Phase 3 clinical studies as a treatment for geographic atrophy (GA). Can you give us an overview?

Chris Simms: Iveric Bio is developing Zimura as a possible treatment for GA, a disease of the retina where a lesion will slowly progress. GA usually starts at the periphery of the retina and progresses towards the fovea. Once it reaches the fovea, patients can suffer severe vision loss. We estimate GA affects approximately 1.5 million patients in the United States alone.

Zimura is part of a class called complement inhibitors. Zimura inhibits part of the complement pathway called C5. It’s at the end of the complement pathway, so inhibiting C5 should preserve the beneficial effects of the upstream pathway while inhibiting the damaging downstream effects, and potentially slowing the rate of growth of GA and potentially preserving visual function for patients.

OM: Describe the typical patient with GA and what’s important to them?

CS: I think this is an area that the broader community needs to be more knowledgeable about. We know that patients with GA are typically older and may have other comorbidities, not just those associated with eye care. If you look at GA specifically, it becomes a bit more nuanced. Some patients have mild or asymptomatic GA, and there are patients with more advanced disease who are symptomatic with vision impairment. That is usually related to how their GA has progressed and where the lesions are in relation to the fovea.

Patient characteristics, their motivation to seek treatment and awareness of the disease itself, may vary based on where the disease presents in a patient’s retina and the effect on vision. What we’re learning is the importance of treating GA early and slowing progression towards the fovea. Patients with extra-foveal lesions (lesions that have not yet entered the fovea) may not present with symptoms today or may have mild vision impairment. However, we believe that with time, we’ll learn more about the importance of earlier treatment and how it may lead to better long-term outcomes.

OM: When might Zimura be available in the United States?

CS: We have completed one of our Phase 3 trials, GATHER 1, and those results have been published. We believe that will serve as a pivotal trial for filing with the FDA. We currently have our second Phase 3 trial, GATHER 2, underway. We expect results from that trial in the second half of 2022. Our goal is to be able to launch the product as soon as we are approved.

One of the important things we monitor in these trials is injection fidelity, which serves as a proxy for patient retention in clinical trials. The injection fidelity rate is calculated by dividing the total number of actual injections for all patients by the total number of expected injections based on the total number of patients enrolled in the trial. We think that’s important because during the COVID-19 pandemic, getting patients in for a clinical trial can be more difficult; also, these are monthly administrations, which places a certain level of burden on both the site and the patient.

For GATHER 2, we are targeting above 90% injection fidelity at 12 months. That has us very encouraged for the results of our second Phase 3 trial. I think this also speaks to the unmet patient need for GA treatments. With no approved treatment options, we believe patients are motivated to continue receiving injections.

OM: Do you plan on working with the eye-care provider (ECP) community in advance of the anticipated approval?

CS: It’s vital and core to our strategy, especially considering where our patients exist today relative to their ECP interaction. Most GA patients, we believe, are diagnosed in a general ophthalmology or optometry setting; and many, but not all, are referred to a retina specialist. Working with that continuum of ECPs is going to be really important.

We believe that, if approved, the most likely ECP to prescribe and administer Zimura will be a retina specialist, and many of the market dynamics will mimic what we see in the anti-VEGF space. That said, not all these patients are being seen in a retina practice today because treatments have not previously been available; they may have been referred in at some time but may not be existing patients under the care of a retina specialist. We’ll be factoring that in as we seek to better understand the patient’s journey and our strategy going forward. OM