Phase IV trial results show Eylea dosing schedule improvement is possible

GlobalData Healthcare 7th February 2020 (Last Updated February 7th, 2020 16:15)

Bayer's recently released results from the trial have shown that there can be greater flexibility in the treatment regimen for patients with macular degeneration using Eylea.

Phase IV trial results show Eylea dosing schedule improvement is possible

Bayer has recently released new data from a Phase IV trial, ALTAIR, investigating Eylea (aflibercept) in patients with wet age-related macular degeneration (wet AMD). Bayer markets Eylea in Europe where it was approved for the treatment of wet AMD in 2012. The results from the trial have shown that there can be greater flexibility in the treatment regimen for patients using Eylea.

Currently, Eylea is administered every four weeks for the first three months and then once every two months following that. The ALTAIR trial showed that at week 96 of treatment, up to 60% of patients were able to receive three-monthly or more injections and that more than 40% of patients were able to receive four-monthly injections, without worsening symptoms.

While the increase in intervals between doses will not work for every patient, it will provide a huge benefit for many wet AMD patients, reducing the number of necessary injections of Eylea. Furthermore, as Eylea is administered by injection into the eye, which can be an unpleasant experience for patients, reducing the frequency of injections of Eylea will significantly reduce the disease burden for wet AMD patients, and ultimately relieve pressures for healthcare providers.

Eylea currently dominates the wet AMD market, and is currently the highest-selling drug in the ophthalmology space. In October 2019, Novartis received approval from the FDA for its wet AMD drug Beovu (brolucizumab), which became the first anti-VEGF therapy to offer a three-monthly dosing interval without compromising on efficacy, giving it a strong competitive edge over Eylea. This makes the ALTAIR trial results particularly significant; by demonstrating the efficacy of Eylea in a reduced dosing frequency schedule, Eylea will be able to compete with Beovu. Bayer will be hopeful that this will reduce the market share that Beovu is able to take from Eylea when Beovu is approved in Europe later this year.

The ALTAIR results also give Eylea a competitive edge over one of its other competitors, Genentech/Roche’s Lucentis (ranibizumab). While Lucentis can be administered on a reduced dosing frequency, its prescribing label states that this is less effective than the recommended once-monthly schedule.