ALTAIR study confirms the effectiveness of Bayer’s aflibercept (EYLEA®) with Treat and Extend dosing regimens in wet AMD
Reading, 5 February 2020 – Bayer is pleased to announce results from the Phase IV ALTAIR study, which evaluated the efficacy and safety of aflibercept (EYLEA®) using two different Treat and Extend (T&E) dosing regimens in patients with wet age-related macular degeneration (wet AMD). At Week 96 up to 60% of patients were able to receive three-monthly (12-week interval) or more injections, with more than 40% able to receive four-monthly (16-week interval) injections.1
Wet AMD is a serious and debilitating sight-threatening condition, with approximately 39,800 new cases diagnosed each year in the UK.2 As a leading cause of vision loss in the elderly, the condition requires ongoing treatment to prevent the worsening of symptoms.3,4 Under a T&E regimen, clinicians will be able to adjust the treatment schedule to the individual needs of every patient and reduce the burden of injections for people with wet AMD.
“Allowing greater flexibility of aflibercept injections in year one, and extension to intervals up to 16 weeks could provide significant benefits for patients and their carers, including fewer medical appointments, reduced waiting lists and an improvement in the overall burden associated with this treatment experience,” said Dr. Jackie Napier, Medical Director of Ophthalmology at Bayer. “As well as ensuring that patients receive the level of care that suits the need of each individual, these results could contribute to relieving capacity pressures and treatment costs for overstretched NHS services”.
The Phase IV ALTAIR included 246 patients, who received aflibercept treatment for three consecutive monthly doses followed by a bimonthly injection interval. At Week 16, patients were randomised 1:1 into two groups, in which the T&E dosing regimen was applied with either a two week interval adjustment or a four-week interval adjustment.1
Results, published in Advances in Therapy, showed that both the two-week and four-week interval adjustments with aflibercept delivered good vision gains. At the primary endpoint at Week 52, change from baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score was 9.0 and 8.4, respectively. These results were maintained out to Week 96, with a mean improvement of 7.6 letters achieved by patients in the two-week adjustment group and 6.1 letters for those in the four-week adjustment group.1
This treatment approach has already been proven to be effective in wet AMD in the ARIES study, a proactive T&E regimen with aflibercept led to good visual acuity gains and the distribution of injection intervals was comparable to that seen in previous studies. The data showed that more than half of patients were extended to injection intervals of 12 weeks or beyond and up to a third of patients were extended to injection intervals of 16 weeks by Week 104.5
In both the ALTAIR and ARIES studies, adverse event findings were consistent with the known safety profile for aflibercept.1,6