Astellas’ Izervay Shows Prolonged Efficacy in 2-Year Study for Geographic Atrophy Treatment

Astellas' Izervay Shows Prolonged Efficacy in 2-Year Study for Geographic Atrophy Treatment

Astellas made a significant acquisition of Iveric Bio earlier this year, primarily motivated by the potential of Iveric’s geographic atrophy candidate, now known as Izervay. This strategic move aimed to establish Izervay as a pivotal revenue source for the company. New findings presented at the American Academy of Ophthalmology 2023 Annual Meeting in San Francisco have shown that the drug’s effectiveness improves over time, setting the stage for a competitive battle in the market.

The 2-year GATHER2 study results, unveiled during the conference, focused on Izervay, which was administered either monthly or every other month, compared to a placebo in patients with geographic atrophy, a severe form of age-related macular degeneration that often leads to vision blind spots.

The study revealed that the drug’s treatment benefits started to manifest as early as six months into the trial, with its effects more than doubling from year 1 to year 2, according to Astellas. Notably, Izervay gained FDA approval earlier in the year based on data demonstrating its efficacy over 12 months, and Astellas secured Iveric Bio in a $4.9 billion deal to gain access to this promising drug.

Also Read: Astellas Claims Positive Results For Izervay In Geographic Atrophy But Remains Vague On Data

In the GATHER2 analysis, Astellas’ monthly dosing of Izervay achieved its primary goal by delivering a significant 14% reduction in the mean rate of lesion growth associated with geographic atrophy. When administered every other month during the second year, following monthly dosing in the first year, Izervay still managed a notable 19% reduction in the mean rate of lesion growth.

However, the drug did not meet its prespecified objective of reducing vision loss, though Astellas plans to further explore this aspect through various sensitivity analyses.

Geographic atrophy is characterized by advanced age-related macular degeneration, resulting in vision blind spots due to damaged areas in the eye.

In terms of safety, the GATHER2 study reported just one case each of non-serious intraocular inflammation and culture-positive endophthalmitis. Notably, there were no recorded instances of ischemic neuropathy or retinal vasculitis, side effects that have been a focal point in the competitive landscape between Astellas’ Izervay and Apellis’ Syfovre.

Also Read: FDA Approves Izervay For Geographic Atrophy

Earlier this year, concerns over retinal vasculitis had led to a launch delay for Apellis’ Syfovre, with reports of occlusive retinal vasculitis in patients receiving the drug. Apellis confirmed 10 cases of this inflammation disorder in October.

Apellis, after reducing its workforce by 25%, reported the shipment of 100,000 vials of Syfovre last month, with a return to weekly growth in demand, according to Chief Commercial Officer Adam Townsend. During the third quarter of 2023, Apellis generated approximately $74 million in revenue from Syfovre, while Astellas reported early sales of Izervay reaching around $8 million.

Astellas had positioned Iveric Bio’s GA drug as a “revenue-generating pillar” to mitigate the impact of losing exclusivity for its star cancer drug, Xtandi. This competition in the GA market promises to be a closely watched and dynamic battleground in the coming months.

“GA is a debilitating, progressive disease that can impact patients’ independence. These exciting results demonstrate year-over-year reductions in the rate of GA lesion growth in patients treated with monthly and every-other-month dosing compared to sham. The GA treatment benefit was observed as early as six months and continued to increase over time. The safety profile over 2 years was consistent with year 1, with no new safety signals identified. These results further validate that IZERVAY is an effective and safe treatment option for patients with GA.” 

– Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research at Sierra Eye Associates, Reno, Nevada

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