Prescribing information

Safety profile with Beovu in clinical trials.

Exhibited an overall well tolerated safety profile1,2

>1,000 patients were treated with Beovu in two Phase III trials.1*

  • Uncommon adverse reactions (<1%) included endophthalmitis, blindness, retinal artery occlusion, retinal detachment, conjunctival hyperaemia, lacrimation increased and vitreous haemorrhage2
  • Most serious adverse reactions included blindness (0.8%), endophthalmitis (0.7%), retinal artery occlusion (0.8%) and retinal detachment (0.7%)2
  • The proportion of eyes with ≥15-letter loss at Week 48 was balanced across both treatments.1  

Percentage of patients with common (≥1%) adverse drug reactions in clinical trials2,3

Table showing the percentage of patients with common (≥1%) adverse drug reactions with Beovu and aflibercept in clinical trials

Additional safety information

Following post-marketing reports, Novartis has confirmed a safety signal of adverse events of ‘retinal vasculitis’ and/or ‘retinal vascular occlusion’ that may result in severe vision loss. Typically these events occurred in the presence of intraocular inflammation. We are in discussion with regulatory authorities to update our summary of product characteristics. Please contact Medical Information for more details.

The primary efficacy endpoint in both studies was non-inferiority in mean BCVA change from baseline to Week 48 as measured by ETDRS. The primary endpoint was met in both studies.1
*Beovu arms in HAWK: 3 mg (n=358), 6 mg (n=360); in HARRIER: 6 mg (n=370).1
In a clinical trial (HAWK), the incidence was 2/60 (3.3%) in Japanese patients on Beovu and 6/300 (2.0%) in all other patients.2
In a clinical trial (HAWK), the incidence was 4/60 (6.7%) in Japanese patients on Beovu and 5/300 (1.7%) in all other patients.2
§Including urticaria, rash, pruritus and erythema.2

BCVA, best corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study.

References

  1. Dugel PU et al. Ophthalmology. 2020; 127: 72–84.
  2. Beovu Summary of Product Characteristics, 2020.
  3. Novartis data on file. BRODOF20-001 Core Data Sheet: 2019
BEO20-C039m June 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]