Two-year data confirm efficacy of EYLEA® (aflibercept solution for injection) Treat and Extend dosing regimens for patients with wet age-related macular degeneration
· Significant visual acuity gains observed in the first year of treatment with aflibercept were largely maintained for 96 weeks
· Up to 60% of patients had an injection of 12 weeks or beyond at the end of the second year
· On average patients received fewer than 4 injections during the second year of treatment
Reading, 24 September, 2018 – Bayer has announced two-year outcomes data from the Phase IV ALTAIR study evaluating the efficacy and safety of aflibercept using Treat and Extend (T&E) dosing regimens in patients who have wet age-related macular degeneration (wAMD). The study results, which were presented today at the 18th Congress of European Society of Retina Specialists (EURETINA) in Vienna, Austria, demonstrated significant benefits for patients through the 96 week observation period.
AMD is the most common cause of vision loss in adults1 with approximately 39,700 new cases diagnosed each year in the UK.2 The T&E dosing regimen offers physicians the option to extend their patients’ dosing intervals by two-, four- and 12-weekly increments depending how long the patient has been on therapy. The advantages of a proactive T&E dosing regimen for intravitreal anti-VEGF therapy, like aflibercept, lie in the opportunity to adjust the treatment interval to the individual needs of every patient, by gradually extending or shortening the dosing interval, based on the patient’s disease activity at the time of injection.
“The ability to tailor aflibercept dosing regimes for individual wet AMD patients offers an important clinical benefit for those who have this sight threatening eye condition,” said Dr Nitin Jain, Senior Medical Advisor at Bayer. “The ALTAIR data show that the significant visual gains achieved for aflibercept patients were maintained after two years and more than 4 in 10 patients were treated with a 4-monthly dosing interval at the end of the second year of the study.”
In the ALTAIR study, vision gains achieved at 52 weeks were largely maintained at the end of 96 weeks using the T&E dosing regimens with aflibercept: a mean improvement of 6.1 letters was achieved by patients in the 4-week adjustment group (4W-Adj), and 7.6 letters for those in the 2-week adjustment group (2W-Adj). These results at 96 weeks were similar to those observed in the pivotal Phase III studies of aflibercept (VIEW1 and VIEW2) at the same timepoint.3
The mean number of injections from week 52 to week 96 in the 4W-Adj group was 3.7 and in the 2W-Adj group 3.6, with a mean last injection interval up to week 96 of 12.5 and 12.2 weeks, respectively. The proportion of patients with a last injection interval of 12 weeks or more at week 96 was up to 60% across the study, and the mean number of injections received through 96 weeks was less than 11. Adverse event findings during the study were consistent with the known safety profile for aflibercept.3
Aflibercept is an anti-VEGF treatment specifically developed to rapidly deliver sustainable improvements in vision, while offering patients and healthcare professionals a predictable dosing programme.3 It is licensed in the UK for the treatment of wet AMD; visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) and visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO); visual impairment due to diabetic macular oedema (DMO) and myopic choroidal neovascularisation (mCNV).4
In July 2018, the European Commission approved a new treatment approach for aflibercept, based on outcomes of the ALTAIR study, allowing clinicians already in the first year of treatment to extend patients’ individual treatment intervals to 12 weeks and beyond based on visual and/or anatomic outcomes.5