Iveric Bio Announces Positive 24-Month Topline Results from Phase 3 Study of IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy

Iveric Bio Announces Positive 24-Month Topline Results from Phase 3 Study of IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy

By, Admin 19 September 2023

 Astellas Pharma US Inc  today announced positive 24-month topline results from the Phase 3 GATHER2 clinical trial evaluating the efficacy and safety of IZERVAY™ (avacincaptad pegol intravitreal solution), a complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Topline results demonstrated that the IZERVAY monthly dosing regimen met the primary objective to significantly slow GA growth compared to sham at 24 months. Additionally, the treatment effect with the every other month dosing regimen for IZERVAY showed a similar reduction in the rate of GA growth versus sham.

Overall, safety after 24 months of treatment was consistent with previously reported 12-month data, with no new safety signals identified. There was one case of culture-positive endophthalmitis and one case of non-serious intraocular inflammation. There were no cases of occlusive or non-occlusive retinal vasculitis or ischemic neuropathy. The rate of choroidal neovascularization (CNV) was 12% in patients treated with IZERVAY and 9% in those treated with sham.

Dhaval Desai, PharmD, Senior Vice President and Chief Development Officer, Iveric Bio, An Astellas Company
"We are excited about these results, which show that IZERVAY continued to slow the rate of GA growth with a consistent safety profile after two years of treatment. We look forward to sharing results at a future scientific congress and with regulatory agencies."

IZERVAY was approved by the U.S. Food and Drug Administration on August 4, 2023, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) and is currently under review by the European Medicines Agency.

Astellas is reviewing potential financial impacts of these results for the fiscal year ending March 31, 2024.

About the GATHER2 Clinical Trial

GATHER2 (NCT04435366) was a randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of avacincaptad pegol (ACP) in 448 enrolled patients with GA secondary to AMD. ACP met its primary objective at 12 months, for which patients were randomized to receive either ACP or sham procedure monthly. In year 2 of the study, patients treated with ACP in year 1 were re-randomized to receive either ACP dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). The primary objective at 24 months was to demonstrate whether, after re-randomization at 12 months, ACP slowed the GA growth rate (slope) in the EM treatment arm compared to sham. CONTRAINDICATIONS

  • IZERVAY is contraindicated in patients with ocular or periocular infections and in patients with active intraocular inflammation.

WARNINGS AND PRECAUTIONS

  • Endophthalmitis and Retinal Detachments
    • Intravitreal injections, including those with IZERVAY, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering IZERVAY in order to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
  • Neovascular AMD
    • In clinical trials, use of IZERVAY was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (7% when administered monthly and 4% in the sham group) by Month 12. Patients receiving IZERVAY should be monitored for signs of neovascular AMD.
  • Increase in Intraocular Pressure
    • Transient increases in intraocular pressure (IOP) may occur after any intravitreal injection, including with IZERVAY. Perfusion of the optic nerve head should be monitored following the injection and managed appropriately.

ADVERSE REACTIONS

    • Most common adverse reactions (incidence ≥5%) reported in patients receiving IZERVAY were conjunctival hemorrhage, increased IOP, blurred vision, and neovascular age-related macular degeneration.

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