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New Macular Degeneration Treatment Offers Enhanced Durability and Efficacy for Many Patients

Nov. 7, 2023 - Eden McCleskey

Although "less is more" is typically a good rule of thumb, sometimes more of a good thing can prove to be …. a good thing.

A recent study led by Houston Methodist ophthalmologist Dr. Charles Wykoff, for instance, found that patients with age-related macular degeneration (AMD) may receive greater therapeutic benefits, on average, with an 8 milligram dose of aflibercept than with a standard 2 milligram dose, including potentially improved outcomes and decreased treatment burden.

Dr. Wykoff, a leading retinal disease researcher, served as the first author of the CANDELA Phase 2 study, which explored the efficacy and safety of the quadruple-strength version of an existing intravitreal injection drug.

The findings from this study shaped the subsequent Phase 3 trials, PULSAR and PHOTON, which provided critical data leading to the FDA's August 2023 approval of the new aflibercept dosage, marketed as Eylea HD.

"The approval of high-dose aflibercept is an important step forward for retinal therapy," said Dr. Wykoff, also an investigator on the two Phase 3 trials. "This next-generation formulation may be able to meaningfully increase the interval between treatments for patients with macular degeneration and diabetic macular edema who require ongoing, repeated dosing, offering the opportunity for visual stability for longer periods and hopefully improved quality of life."

Dr. Wykoff and colleagues presented a first look at two-year data from the PULSAR and PHOTON studies at the American Academy of Ophthalmology's Annual Meeting that concluded November 6. The precursor CANDELA study was published in JAMA Ophthalmology in August.

CANDELA did not meet its initial primary endpoint, the proportion of eyes without fluid in the central subfield eight weeks after last dose. However, the 8 milligram aflibercept treatment group did demonstrate numerically greater improvements in both anatomic outcomes and visual function that were consistent across multiple efficacy measures over the course of the study.

"We observed that the retinas appeared to be drier," Dr. Wykoff explained. "While these positive results were not enough to reach statistical significance, possibly related to the study's small sample size of 106 eyes, they were compelling enough to proceed to those two larger, pivotal trials, ultimately leading to FDA approval of the new therapeutic option."

High-dose aflibercept aims to offer a longer-lasting treatment option for patients who traditionally need injections every one to three months.

Current therapies, while effective, often fall short in real-world settings due to patients' sometimes inconsistent follow-up intervals, leading to suboptimal outcomes. By potentially extending the interval between doses, aflibercept 8 milligram offers a theoretically promising solution to this adherence issue.

Despite the high dosage, the safety profile of Eylea HD appears to be consistent with the lower 2 milligram aflibercept dose, which has been a standard treatment for neovascular AMD and DME for several years. According to Dr. Wykoff, this may open the door to more manageable treatment schedules for patients without compromising safety.

"This medication is a welcome addition to our arsenal against blinding retinal diseases, not a replacement for existing anti-VEGF medications, which continue to work perfectly well for many patients," Dr. Wykoff emphasized. "This is another avenue for clinicians to further customize treatment plans based on the specific needs of each individual patient, especially those requiring more frequent intervention."

Eylea HD is now approved for use in both AMD and DME, offering relief to millions of patients affected by these chronic, sight-threatening conditions.

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