Prescribing information

 

Key efficacy data for LUCENTIS 0.2 mg in the treatment of ROP.

 

Lucentis is indicated in preterm infants for the treatment of ROP with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP).1

LUCENTIS is the first anti-VEGF approved for the treatment of ROP in the EU1

Lucentis targets VEGF, which is thought to be the main driver of pathologic blood vessel growth that occurs in ROP.2,3

LUCENTIS offered a higher success rate* vs laser for the treatment of ROP2†

Graph showing treatment success rate at week 24 with LUCENTIS vs laser in the RAINBOW study

Adapted from Stahl et al. 2019.2

 

Diagram showing the design of the RAINBOW study

RAINBOW was a randomised, open-label, superiority trial to assess the efficacy and safety of intravitreal ranibizumab vs laser therapy for the treatment of ROP. Eligible infants had a birthweight less than 1,500 g and a diagnosis of bilateral ROP zone I stage 1+, 2+, 3 or 3+, or zone II stage 3+, or aggressive posterior ROP (AP-ROP). The primary objective was to investigate whether intravitreal ranibizumab 0.2 mg had superior efficacy to laser therapy in the treatment of ROP, as defined by survival without active ROP, unfavourable structural outcomes, or the need for a treatment modality other than that assigned, in both eyes, up to 24 weeks after starting investigational treatment.2

 

Indications1

LUCENTIS 0.5 mg is indicated in adults for:

  • The treatment of neovascular (wet) age-related macular degeneration (AMD)
  • The treatment of visual impairment due to diabetic macular oedema (DMO)
  • The treatment of proliferative diabetic retinopathy (PDR)
  • The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
  • The treatment of visual impairment due to choroidal neovascularisation (CNV)

LUCENTIS 0.2 mg is indicated in preterm infants for:

  • The treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.

 

ROP, retinopathy of prematurity; VEGF, vascular endothelial growth factor.

References

  1. LUCENTIS® (ranibizumab) Summary of Product Characteristics, July 2020.
  2. Stahl A et al. Lancet 2019;394(10208):1551–1559.
  3. Stahl A et al. JAMA Pediatr 2018;172(3):278–286.
LUC20-C030g September 2020.
×

Ask Speakers

×

Medical Information Request

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]