Erin Henry is the VP of Product Strategy and Innovation at Iveric Bio, An Astellas Company. She has more than 15 years of biopharma experience, leading teams in ophthalmology clinical development, medical affairs, marketing and product strategy. Iveric Bio is a biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases. Last year, the FDA approved IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to AMD.
Ophthalmology Management: What is the significance of IZERVAY and how does it work?
Erin Henry: IZERVAY is the only FDA-approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two pivotal trials. IZERVAY is also the first FDA-approved GA treatment to demonstrate a statistically significant reduction in the rate of GA progression at the 2-year timepoint in a pivotal trial.
IZERVAY is a molecule with a differentiated mechanism of action and a well-documented efficacy and safety profile. It is a complement C5 protein inhibitor and an RNA aptamer. By targeting C5, IZERVAY may preserve upstream benefits of the complement system while preventing formation of the membrane attack complex, reducing inflammation and cell death associated with the development and progression of GA.1
OM: Iveric Bio reported results from the GATHER2 Phase 3 trial. Can you give us an overview?
EH: The latest results from the GATHER2 Phase 3 clinical trial, which were presented during AAO 2023, demonstrated IZERVAY dosed monthly or every other month (EOM) continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through 2 years.2 The IZERVAY treatment effect vs sham more than doubled over 2 years compared to 1 year.2
IZERVAY’s safety profile in GATHER2 was consistent with year 1, with no cases of ischemic optic neuropathy or retinal vasculitis.2 Over 2 years, only a slight increase in the incidence of choroidal neovascularization (CNV) was observed for IZERVAY pooled vs sham (11.6% vs 9.0%, respectively); in year 2, the incidence of CNV was similar for IZERVAY EOM dosing vs sham.2
GA impacts an estimated 1.5 million people in the United States.3 However, approximately 75% of people living with this progressive disease in the United States are believed to be undiagnosed.4 Given this significant unmet need, we are pleased that with IZERVAY, we are able to provide a new differentiated GA therapy with a well-documented efficacy and safety profile. Across the GATHER clinical trials, there were no cases of retinal vasculitis, and the safety profile in clinical practice to date has been consistent with the GATHER study results.
OM: Your company initiated a campaign to raise awareness about GA. Can you tell us more?
EH: More to See is an educational campaign that aims to spread awareness of the impact of GA. The campaign website (www.askaboutga.com) includes resources intended to educate individuals who may be struggling with GA and those who have been diagnosed with AMD. As a part of the campaign, we partnered with two-time Emmy award-winning actor, Eric Stonestreet, to encourage people to join him in prioritizing their eye health and raising awareness about GA. Eric’s maternal grandmother lived with significant vision loss due to AMD and was later diagnosed with GA, and his mother, was also diagnosed with AMD.
OM: What other developments are in the pipeline for the US?
EH: The research and development strategy of Astellas, which acquired Iveric Bio last year, is based on a Focus Area Approach. As part of our Blindness & Regeneration Primary Focus area, we are working to develop new treatment options to replace, preserve and restore the function of cells critical for vision. In the United States, avacincaptad pegol is being evaluated in an ongoing study for autosomal recessive Stargardt patients. Our lead ophthalmology cell therapy candidate, ASP7317, is in Phase 1 clinical development for GA secondary to AMD. That trial is currently recruiting patients with GA secondary to dry AMD in the United States. OM
REFERENCES
1. Desai D, Dugel PU. Complement cascade inhibition in geographic atrophy: a review. Eye (Lond). 2022;36:294-302.
2. Khanani AM, Patel SS, Staurenghio, et al. GATHER2: Two-Year Data. Presented at American Academy of Ophthalmology 127th Annual Meeting, San Francisco, Nov. 3-6, 2023.
3. Jaffe GJ, Westby K, Csaky KG, et al. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021;128:576-586.
4. Data on file. Iveric Bio, An Astellas Company, Parsippany, N.J.
