Detailed data from vital studies with aflibercept 8 mg demonstrate sustained advancements in visual perceptivity and anatomic measures with large maturity of cases maintaining treatment intervals of 16
Aflibercept 8 mg maintained 16- week dosing intervals in over to 89 of cases with as many as 5 injections until week 48/ Aflibercept 8 mg demonstratednon-inferior vision earnings to Eylea ®( aflibercept 2 mg) with 83 of cases with neovascular( wet) age- related macular degeneration( nAMD) and 93 of cases with diabetic macular edema( DME) maintaining dosing intervals of 12 weeks or longer through week 48/ Superior fluid control in nAMD and robust complaint control through to week 48 in nAMD and DME/ In both studies, analogous reductions in mean change of central retinal consistence( CRT) were achieved in cases entering aflibercept 8 mg with 12- and 16- week dosing versus Eylea with 8- week dosing at week 48/ Safety of aflibercept 8 mg was harmonious with the well- established safety profile of Eylea
Bayer AG moment blazoned that detailed results from two vital clinical studies have demonstrated sustained visual perceptivity and anatomic advancements with aflibercept 8 mg with 12- and 16- week dosing rules versus Eylea ®( aflibercept 2 mg) with 8- week dosing at week 48.
The phase III PULSAR trial in neovascular( wet) age- related macular degeneration( nAMD) and phase II/ III PHOTON trial in diabetic macular edema( DME) independently met their primary endpoint ofnon-inferiority of aflibercept 8 mg extended dosing rules for stylish corrected visual perceptivity( BCVA) at week 48, compared to Eylea cured every 8 weeks, all following original yearly boluses. Cases were randomized in three different arms and all cases in the aflibercept 8 mg arms were continuously estimated under strict, clinically applicable, and patient focused dosing authority revision( DRM) criteria. 77 of nAMD and 89 of DME cases maintained every 16- week dosing intervals with aflibercept 8 mg at week 48 in the clinical trials.
In the pooled data- analysis, aflibercept 8 mg demonstrated sustained visual perceptivity with 83 of nAMD cases and 93 of DME cases, maintaining dosing intervals of 12 weeks or longer through week 48.
As presented at the Retina Society, in the PULSAR trial in nAMD, the observed computation mean change from birth in BCVA at week 48 was6.7 letters in the aflibercept 8 mg arm under a 12- week injection interval and6.2 letters in the aflibercept 8 mg arm under a 16- week injection interval versus7.6 letters in the Eylea arm under 8- week injection interval. For cases in the aflibercept 8 mg arm under the 16- week dosing schedule, the mean number of injections to week 48 was reduced to5.2, and under the 12- week dosing schedule6.1 injections, compared with6.9 in the Eylea arm on an 8- week dosing schedule. The proportion of cases with BCVA letter score earnings( measured by the ETDRS1 letter score) at week 48 was similar among the treatment groups.
PULSAR also met its crucial secondary endpoint, demonstrating superiority of aflibercept 8 mg in perfecting anatomic issues of retinal fluid at week 16 versus Eylea( p = 0.0002) which was maintained through week 48. specially, 71 and 67 of aflibercept 8 mg nAMD cases in the 12- and 16- week dosing arms had no retinal fluid in the center subfield, compared to 59 for Eylea with 8- week dosing at week 48. The median time to a fluid-free center subfield in the aflibercept 8 mg 12- and 16- week arms were 4 weeks versus 8 weeks in the Eylea arm. analogous reductions in mean change of central retinal consistence( CRT) from birth were achieved in cases entering aflibercept 8 mg 12- and 16- week dosing versus Eylea with 8- week dosing at week 48.
In the PHOTON trial in DME, the observed computation mean change from birth in BCVA at week 48 was8.8 letters in the aflibercept 8 mg arm under a 12- week injection interval and7.9 letters in the aflibercept 8 mg arm under a 16- week injection interval versus9.2 letters in the Eylea arm with every 8- week injection interval. Until week 48, cases in the aflibercept 8 mg arm on a 16- week dosing schedule entered a mean number of4.9 injections and5.7 injections on a 12- week dosing schedule, compared to7.7 injections in the Eylea arm under an 8- week dosing schedule. Among DME cases, there was a mean reduction of 14 mm2( n = 328) and 9 mm2( n = 136) in the total area of fluorescein leakage from birth for aflibercept 8 mg on 12- week and 16- week dosing groups, independently, compared to 9 mm2 for Eylea( n = 167), per an exploratory analysis of PHOTON. Reductions in fluorescein leakage, a measure of complaint exertion, are associated with complaint enhancement. analogous reductions in mean change from birth of central retinal consistence( CRT) at week 48 were achieved in DME cases entering aflibercept 8 mg with 12- and 16- week dosing versus Eylea with 8- week dosing.
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