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Safety in Lactation: Subfoveal choroidal neovascularisation

21 September 2020VEGF inhibitors are used for age-related macular degeneration, administered by intravitreal injection. They are also large molecules with a high molecular weight. These factors will…
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Refrigerated Storage

EyleaBayer PLC

Bayer PLC
Eylea
Solution for injection in a vial (40mg/mL)

In the event of an inadvertent temperature excursion the following data may be used:
The product literature states that prior to usage, the unopened vial may be kept at room temperature (below 25°C) for up to 24 hours.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

19 March 2021
London MI Service

ZaltrapSanofi

Sanofi
Zaltrap
25mg/mL concentrate for solution for infusion

Contact Sanofi in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

12 October 2020
London MI Service

Lactation Safety Information

Yes
No published evidence of safety
Negligible levels anticipated in milk due to the drug’s properties
17 September 2020

New Medicines

EyleaRetinopathy of prematurity (ROP)

Information

Eylea
Licence extension / variation
Bayer
Regeneron

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase III Clinical Trials
Nov 21Bayer has filed applications for aflibercept (solution for injection) for treatment-requiring retinopathy of prematurity (ROP) in premature babies in the EU and Japan [5].
Dec 20PIII trials ongoing [3,4].

Category

Fully humanised fusion protein binding all forms of VEGF-A and PIGF
ROP develops in 16% of all premature births, the figure rising to around 60% of infants weighing less than 1500 g at birth and 65% for infants less than 1250 g; however, severe ROP is uncommon. A review in the USA in 2008 looked at 4.67 million live births. The total incidence of ROP was 0.12% overall and 7.35% for premature infants with hospital stay greater than 14 days [1].
Retinopathy of prematurity (ROP)
Intravitreal

Trial or other data

Dec 21FIREFLEYE NEXT open-label extension study (NCT04015180) to evaluate long-term outcomes of the FIREFLEYE study is active, but no longer recruiting. 96 participants were enrolled in the study worldwide including the UK. Estimated completion date is Jul 2025 [7].
Dec 21PIII BUTTERFLEYE trial is active, but no longer recruiting. Estimated completion date is Sep 2022 [7]
Nov 21Bayer report EU filing was based on positive results from the PIII FIREFLEYE trial completed in Feb 21 at the Congress of the European Society of Retina Specialists (EURETINA). Although the study missed statistical significance for the primary endpoint of demonstrating non-inferiority of aflibercept 0.4 mg to laser (90% CI for treatment difference: −8.0% to +16.2%), the treatment success with aflibercept 0.4mg (85.5%) is considered clinically relevant. In the control group (laser surgery) a response rate of 82.1% was observed. Aflibercept was demonstrated to be efficacious, safe and well-tolerated. A PIIIb extension study, FIREFLEYE NEXT, is ongoing [6].
Mar 20PIII Extension study to the FIREFLEYE trial started (EudraCT2018-003180-54; NCT04015180). The non-randomised, open-label PIII trial (n=100 planned) is designed to determine the binocular best-corrected visual acuity in Snellen equivalent score (at 5 years of age) and proportion of subjects with ocular or systemic AEs and is estimated to complete Jun 25 [3,4].
Oct 19PIII BUTTERFLEYE trial to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP) starts (NCT04101721; VGFTe-ROP1920). 112 patients will be recruited in the US, Colombia & Thailand. Primary outcome is proportion of patients with absence of active ROP and of unfavorable structural outcomes at week 52 (chronological age); collection of these data is due to complete Apr 22 [2].
Sep 19PIII FIREFLEYE trial started (EudraCT2018-002611-99; NCT04004208). This open-label, multi-centre international RCT aims to assess the efficacy, safety, and tolerability of intravitreal (IVT) aflibercept vs laser photocoagulation in patients with Retinopathy of Prematurity (ROP). Primary outcome is proportion of patients (n=113 planned) with absence of active ROP and unfavourable structural outcomes at 24 weeks after starting treatment. Estimated primary collection date is Feb 2021 [3,4].

Information

Eylea
New formulation
Bayer
Bayer

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

VEGF inhibitor. 8mg formulation dosed 12 or 16 weekly.
The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more and there are around 70,000 new diagnoses in the UK each year [2].
Wet age-related macular degeneration (AMD) and diabetic macular oedema - 8mg formulation
Intravitreal

Information

aflibercept biosimilar (ABP 938)
Biosimilar
Amgen
Amgen

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Vascular endothelial growth factor (VEGF) inhibitor
The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more, though 90% of this is the dry type [2].
Wet age-related macular degeneration (AMD), macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema
Intravitreal

Information

aflibercept biosimilar (M710)
Biosimilar
Janssen
Janssen

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Fully humanised fusion protein binding all forms of VEGF-A and PIGF
AMD is the most common cause of severe visual impairment in older adults in the developed world and responsible for two thirds of registrations of visual impairment in the UK. The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more; there are around 70,000 new diagnoses in the UK each year [2].
Wet age-related macular degeneration (AMD)
Intravitreal

Information

aflibercept biosimilar (FYB203)
Biosimilar
Bioeq
Bioeq

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

vascular endothelial growth factor (VEGF) inhibitor
Most common cause of severe visual impairment in older adults, the estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more [12].
Wet age-related macular degeneration (AMD)
Intravitreal

Information

aflibercept biosimilar (SB15)
Biosimilar
Biogen
Biogen

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Vascular endothelial growth factor (VEGF) inhibitor
The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more. There are around 70,000 new diagnoses in the UK each year [2].
Wet age-related macular degeneration (AMD)
Intravitreal

aflibercept biosimilar (CT-P42) Diabetic macular oedema

Information

aflibercept biosimilar (CT-P42)
Biosimilar
Celltrion
Celltrion

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

Vascular endothelial growth factor (VEGF) inhibitor
Diabetes is the most common cause of severe sight impairment in working-age people in England, Wales and Scotland. One study found that macular oedema (MO) is present in 9% of the population with diabetes. In type 2 diabetes, changes may be found at diagnosis because subclinical hyperglycaemia may have been present for a prolonged preceding period. Over 25 years, cumulative rate of progression to diabetic retinopathy is 83%, to DMO is 29% & to clinically significant MO 17% [1].
Diabetic macular oedema
Intravitreal

Information

aflibercept biosimilar (SOK583A1)
Biosimilar
Sandoz
Sandoz

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Binds and inhibits ocular vascular endothelial growth factor (VEGF-A)
AMD is responsible for two thirds of registrations of visual impairment in the UK. There are around 70,000 new diagnoses in the UK each year [2].
Age related macular degeneration (neovascular, wet type)
Intravitreal