Brolucizumab (2) – Beovu®

• Clinical trials
  • The KESTREL and KITE studies are randomised, double-blind Phase III trials comparing brolucizumab with aflibercept.
  • The benefit assessment is based on the two double-blind, randomised, active-controlled trials, KESTREL and KITE, as well as the meta-analysis of both trials at week 52.

Adults with visual impairment due to diabetic macular oedema (DME)

• For adults with visual impairment due to DME, the additional benefit of brolucizumab over aflibercept is not proven.
• mortality
  • For the endpoint of all-cause mortality, there is no statistically significant difference between the treatment groups, either at the level of individual studies or in the meta-analysis of the two studies.
• Morbidity – Best-corrected visual acuity (BCVA) – improvement of ≥ 10 and ≥ 15 ETDRS letters
  • For the BCVA endpoint (improvement of ≥ 10 and ≥ 15 ETDRS letters), no statistically significant difference between the treatment groups was observed either at the individual study level or in the meta-analysis of the two studies.
• Quality of life – National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) – improvement of ≥ 15 points
  • For the total score of the NEI VFQ-25 (improvement of ≥ 15 points), there was no statistically significant difference between the treatment groups at the individual study level; the same applies to the meta-analysis of the studies.
• Side effects – AEs, SAEs, discontinuation due to AEs
  • No statistically significant differences were observed between the treatment groups for the overall rates of AEs, SAEs or discontinuations due to AEs.
• Side effects – intraocular inflammation (AE) and intraocular inflammation (SAE)
  • For the endpoints intraocular inflammation (AE) and intraocular inflammation (SAE), no statistically significant difference between the treatment groups was observed either at the level of individual studies or in the meta-analysis of the studies.
• Overall assessment / Conclusion
  • In summary, there was no statistically significant difference in mortality between the treatment groups at week 52.
  • In the morbidity category, no statistically significant difference between brolucizumab and aflibercept in the change in best-corrected visual acuity can be inferred at week 52.
  • In the quality of life category, there was no statistically significant difference between brolucizumab and the appropriate comparator therapy, aflibercept, in terms of vision-related quality of life as assessed using the NEI VFQ-25.
  • In the category of side effects, no advantages or disadvantages relevant to the benefit assessment can be identified for brolucizumab compared with aflibercept overall.
  • Overall, based on the studies submitted for week 52, there are neither advantages nor disadvantages for brolucizumab compared with the appropriate comparator therapy, aflibercept, in the treatment of visual impairment resulting from DMÖ.
  • An additional benefit of brolucizumab compared with the appropriate comparator therapy, aflibercept, is therefore not proven for adults with visual impairment resulting from DMÖ.

Courtesy translation only, please refer to the German original.