Bayer’s high dose therapy TGA approved in age-related macular degeneration

Pharma News: Every year approximately 21,000 new cases of wet age-related macular degeneration (wAMD) are diagnosed in Australia. Currently, 80,000 Australians receive anti-VEGF eye injections to retain vision and prevent blindness.

TGA approved Eylea (aflibercept) 8 mg represents a higher dose to the standard of care Eylea 2 mg which is currently offered to patients in Australia.

According to Macular Disease Foundation Australia (MDFA), 20% of people will stop treatment in their first year, and 50% of people will stop their eye injections within 5 years putting them at risk of severe vision loss or blindness. Longer-acting therapies will overcome the treatment burden often associated with patient drop out, as well as other issues like macular scarring or fibrosis.

The approvals have been based on positive results from the PULSAR clinical trial in wAMD and the PHOTON trial in diabetic macular oedema (DME). Both studies met their primary endpoint of non-inferior best corrected visual acuity changes with Eylea 8 mg with 12- or 16-week dosing regimens compared to Eylea 2 mg with a fixed eight-week treatment interval at week 48.

In the PULSAR study, 88% of participants achieved a dosing interval of 12 weeks or more by the study’s conclusion, with 78% maintaining this interval consistently over the two-year period. Moreover, 71% met extension criteria for even longer dosing intervals, including 47% for ≥20-week intervals and 28% for 24-week intervals, demonstrating the potential for extended treatment intervals with this higher dose regimen.

High dose Eylea will compete with Roche’s Vabysmo (faricimab), a VEGF and Ang2 inhibitor, its biggest rival currently on the market.

Roche recently presented results of the TENAYA and LUCERNE trials of Vabysmo at the Association for Research in Vision and Ophthalmology (ARVO) conference.

The two year post-hoc analysis revealed Vabysmo’s extended treatment benefits and potential for dosing every 20 weeks in wet age-related macular degeneration (wAMD). Compared to Eylea 2mg, nearly 80% of Vabysmo patients achieved dosing intervals of 12 or 16 weeks, with 56% successfully extending to 20 weeks. Patients with less fluid and fewer pigment epithelial detachments were more likely to qualify for extended dosing.

Roche is also planning to relaunch its Susvimo drug-eluting implant for wAMD, following a market recall in 2022. Roche is reportedly aiming to expand Susvimo’s indication into DME and diabetic retinopathy.

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