Novartis to Present New Data Highlighting Recent Safety-Specific Beovu Studies at EURETINA 2021

At the upcoming EURETINA 2021 Virtual Congress, Novartis will present new data highlighting safety-specific Beovu studies, including:  

• The Safety-Specific, Next-Generation Optical Coherence Tomography Analysis from HAWK: Preliminary Qualitative OCT Findings Associated with Intraocular Inflammation
  • Key Takeaway: Efforts from the Novartis-led safety coalition found that the presence of anatomical changes in the retina known as stalagmites on OCT scans may be an important marker for IOI in wet AMD patients treated with Beovu, although further investigation is warranted.
• The immunologic features of Beovu-associated retinal vasculitis / retinal vessel occlusion
  • Key Takeaway: Efforts from the Novartis-led safety coalition provide additional information to healthcare providers when treating wet AMD patients with Beovu. In clinical practice, clinicians should exercise continued vigilance for IOI-related AEs, evaluate carefully for signs of RV and/or RO, and educate patients to return promptly should symptoms or visual loss develop. IOI-related AEs should be promptly managed.
• Brolucizumab q16w/q12w dosing potential in nAMD: A post-hoc evaluation of data from the HAWK and HARRIER studies
  • Key Takeaway: The new data suggests that, with modified criteria and protocols to determine dosing intervals, roughly 55% of brolucizumab patients would be dosed on 16-week dosing intervals, and 78% to 12-week or higher dosing intervals, through year one in the HAWK and HARRIER trials.
• Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KESTREL and KITE studies
  • Key takeaway: New data from KESTREL and KITE demonstrate that more than 87% of Beovu 6 mg patients who successfully completed an initial 12-week dosing interval remained on 12-week dosing through year one.

Other noteworthy data being presented at the meeting, include:

• Long-term efficacy outcomes with brolucizumab vs aflibercept treatment in patients with early residual fluid presence in nAMD: post hoc analysis of pooled data from HAWK & HARRIER Studies
  • Key Takeaway: In patients with wet AMD with early residual fluid in the HAWK and HARRIER studies, patients treated with brolucizumab achieved greater BCVA and CST reduction versus patients treated with aflibercept and subsequent overall fluid resolution (IRF and/or SRF through week 96) was greater in patients treated with brolucizumab versus patients treated with aflibercept.
  • Retinal fluid is a key marker of disease activity. The utility of these measures has not been established.
• HAWK and HARRIER 48-week data: potential for treatment interval extension in patients with nAMD disease activity at Week 16
  • Key Takeaway: These preliminary findings suggest there is potential for longer intervals between injections with Beovu. Additional studies are necessary to confirm.