Clinical Izervay Demonstrates Prolonged Efficacy in GATHER2 Study Amidst Competitive...

Izervay Demonstrates Prolonged Efficacy in GATHER2 Study Amidst Competitive Landscape

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Astellas Pharmaceuticals made a substantial $5.9 billion investment earlier this year when it acquired Iveric Bio. The driving force behind this acquisition was the potential of Iveric’s geographic atrophy candidate, now known as Izervay, which Astellas saw as a key source of future revenue growth. As the market rivalry intensifies, the two-year data from the GATHER2 study indicate that Izervay’s effectiveness increases over time.

Findings from the 2-year GATHER2 study were resented only recently in San Francisco at the annual meeting of the American Academy of Ophthalmology. The trial was designed to assess the efficacy of Astellas’ Izervay, administered either monthly or every other month, in comparison to a placebo for patients with geographic atrophy, a severe form of age-related macular degeneration.

The results revealed that the treatment benefits of Izervay began to manifest as early as six months into the trial. Furthermore, the effects of the drug more than doubled from the first year to the second year, according to a statement from Astellas. This data was instrumental in securing Izervay’s FDA approval earlier in the year. It was due to these landmark results that Astellas made the decision to acquire Iveric Bio.

In the latest analysis of the GATHER2 study, the monthly dosing of Izervay from Astellas successfully achieved its primary objective by delivering a statistically significant year-over-year reduction of 14% in the mean rate of lesion growth caused by geographic atrophy. Additionally, the administration of Izervay every other month during the second year, following monthly dosing in the first year, resulted in a 19% reduction in the mean rate of lesion growth.

However, it’s crucial to highlight that Izervay did not achieve its predefined goal of reducing vision loss. Astellas has indicated that this aspect will be subject to further investigation through various sensitivity analyses.

An advanced form of age-related macular degeneration, Geographic Atrophy is often causes blind spots in patients’ vision. Lesions in the eye represent areas that have sustained damage from the disease. When it comes to safety concerns in the study, there were notably no reported cases of ischemic neuropathy or retinal vasculitis, however in the GATHER2 analysis one case of culture-positive endophthalmitis and one case of non-serious intraocular inflammation were mentioned.

The safety profile of both Izervay and Apellis’ Syfovre, a competing drug, is of paramount importance in the ongoing competition for a share of the geographic atrophy treatment market. Concerns about retinal vasculitis previously caused a delay in the launch of the Apellis drug.

A letter was issued to medical practitioners this July by the Americal Society of Retinal Specialists that highlighted six instances where patients who received Syfovre developed occlusive retinal vasculitis.  More recently, in early October, Apellis confirmed 10 cases of this sight-threatening inflammation disorder. Despite a recent reduction in its workforce by 25%, Apellis reported shipping 100,000 vials of Syfovre, and their chief commercial officer, Adam Townsend, expressed optimism about the return to weekly growth in demand.

During the third quarter of 2023, Apellis reported estimated earnings of $74 million from its drug. In contrast, Astellas reported around $8 million in early sales from Izervay.

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