Will PBS listing of Bayer’s high dose Eylea gain an edge over competitor?

Pharma News: Every year, around 21,000 Australians are diagnosed with wet age-related macular degeneration (wAMD), a condition that can lead to severe vision loss. Currently, 80,000 people across the country receive anti-VEGF eye injections to help retain their sight and prevent blindness.

From 1 October, Bayer’s vascular endothelial growth factor (VEGF) inhibitor, Eylea (aflibercept) 8mg, will be made available through the Pharmaceutical Benefits Scheme (PBS). This higher dose of the drug is expected to benefit approximately 11,000 Australians with wAMD or diabetic macular oedema (DMO).

The Macular Disease Foundation Australia (MDFA) warns that treatment adherence remains a major challenge. According to the MDFA, 20% of patients stop receiving eye injections within the first year, and 50% discontinue within five years.

This drop-out rate leaves patients vulnerable to severe vision loss or blindness. Longer-acting therapies like Eylea 8mg could help reduce this treatment burden by addressing issues such as macular scarring or fibrosis, which can arise with inconsistent care.

Professor Andrew Chang, a Sydney-based ophthalmologist involved in clinical trials for Eylea 8mg, hailed the PBS subsidy as a crucial advancement. “

This is a welcome development in eye care at a time when avoidable vision loss and blindness continues to grow,” he said.

“As the population ages and diabetes becomes more prevalent, the demand for sight-saving therapies is on the rise,” Professor Chang noted.

Eye injections are among the most common medical procedures in the country, he explained, adding that “one-in-six Australians with age-related macular degeneration will suffer vision loss.” As treatments advance, Professor Chang emphasised the goal of reducing both the disease burden and the treatment burden for patients.

Eylea 8mg’s efficacy is based on results from the PULSAR clinical trial for wAMD and the PHOTON trial for diabetic macular oedema. Both trials achieved their primary endpoints, demonstrating that Eylea 8mg, with 12- or 16-week dosing regimens, was non-inferior in improving visual acuity compared to the 2mg version, which has been PBS-listed since 2012 with an 8-week treatment interval.

In the PULSAR study, 88% of participants were able to maintain a dosing interval of 12 weeks or more by the study’s end, with 78% consistently achieving this interval over two years. Notably, 71% of participants met the criteria for even longer intervals, with 47% able to extend to 20 weeks and 28% achieving 24-week intervals. These results underscore the potential of high dose Eylea for extended treatment periods, reducing the frequency of injections for patients.

Manoj Saxena, CEO of Bayer ANZ and Country Division Head for the Pharmaceutical Division, underscored the company’s commitment to combating vision loss.

“Bayer has a strong heritage in eye care and remains focused on delivering innovations for more patients with common sight-stealing diseases,” he said.

He added, “Our company is proud to support Australians and play its part in addressing the increasing rates of avoidable vision loss and blindness from age-related macular degeneration and diabetic macular oedema.”

The PBS listing of Eylea 8mg faces competition from Roche’s Vabysmo (faricimab), a VEGF and Ang2 inhibitor, which is currently its biggest rival.

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.