Sandoz receives US FDA approval to expand Enzeevu (aflibercept-abzv) label for multiple retinal indications

DJ Sandoz receives US FDA approval to expand Enzeevu (aflibercept-abzv) label for multiple retinal indications

Sandoz Group AG / Key word(s): Regulatory Approval 
Sandoz receives US FDA approval to expand Enzeevu (aflibercept-abzv) label for multiple retinal indications 
2026-02-18 / 07:00 CET/CEST 
 
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MEDIA RELEASE 
 
 -- Approved indications now include all retinal indications, in addition to previously-approved indication of nAMD 
 -- More than 30 million Americans live with retinal diseases, which can lead to vision loss or blindness^1 
 -- Enzeevu^ is expected to launch in US in Q4 2026 
    
Basel, February 18, 2026 - Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced 
that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu^ (aflibercept-abzv), to 
include multiple retinal indications. Enzeevu^ was originally approved by the FDA for the treatment of neovascular 
(wet) age-related macular degeneration (nAMD) in August 2024^2. 
The most recent approval expands the Enzeevu^ label indications to include macular edema following retinal vein 
occlusion (RVO), diabetic retinopathy (DR) and diabetic macular edema (DME), along with the previously approved 
indication of nAMD. This expansion offers retina specialists a clinically-proven aflibercept biosimilar option to treat 
more patients across these retinal diseases. 
Keren Haruvi, President Sandoz North America said: "More than 30 million people in the US are living with retinal 
diseases that can lead to irreversible vision loss or blindness. With this expanded label, we're broadening our ability 
to deliver affordable care to those impacted by these devastating diseases." 
Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines 
sustainably and affordably, with a leading global portfolio comprising 13 biosimilars and a further 27 assets in 
various stages of development. 
This approval strengthens the company's position in ophthalmology, following the acquisition of the US biosimilar 
Cimerli^ (ranibizumab-eqrn) in 2024 and the European launch of Afqlir^ (aflibercept) in 2025. It also represents 
another step towards the overall strategic objective of capitalizing on a projected USD 320 billion biosimilar market 
opportunity over the next 10 years^3. Enzeevu^ is expected to launch in the US in the fourth quarter of 2026, or 
earlier under certain circumstances. 
ABOUT Enzeevu^ (aflibercept-abzv) 
The active ingredient in Enzeevu^ is aflibercept. Aflibercept is a recombinant fusion protein that binds to vascular 
endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. In patients 
with neovascular (wet) age-related macular degeneration (nAMD), macular edema following retinal vein occlusion (RVO), 
diabetic retinopathy (DR) and diabetic macular edema (DME), aflibercept is administered into the eye as an intravitreal 
injection helping to inhibit abnormal blood vessel growth and reduce vascular permeability associated with retinal 
diseases^4. 
INDICATIONS 
Enzeevu^ (aflibercept-abzv) injection, for intravitreal use, is indicated for the treatment of patients with 
neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), 
diabetic retinopathy (DR) and diabetic macular edema (DME). 
SELECT IMPORTANT SAFETY INFORMATION 
CONTRAINDICATIONS: Ocular or periocular infection, active intraocular inflammation, hypersensitivity 
WARNINGS AND PRECAUTIONS: Endophthalmitis, retinal detachments and retinal vasculitis with or without occlusion may 
occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or 
symptoms suggestive of endophthalmitis, retinal detachment or retinal vasculitis without delay and should be managed 
appropriately; increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection; there 
is a potential risk of arterial thromboembolic events following intravitreal use of vascular endothelial growth factor 
(VEGF) inhibitors 
ADVERSE REACTIONS: The most common adverse reactions (=5%) reported in patients receiving aflibercept were conjunctival 
hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters and intraocular pressure increased 
This is not the complete list of all the safety information for Enzeevu^. Please see full Prescribing Information for 
Enzeevu^. 
Select Important Safety Information 
INDICATIONS 
Cimerli^ (ranibizumab-eqrn) injection, for intravitreal use, is indicated for the treatment of patients with: 
Neovascular (Wet) Age-Related Macular Degeneration (AMD); Macular Edema Following Retinal Vein Occlusion (RVO); 
Diabetic Macular Edema (DME); Diabetic Retinopathy (DR); Myopic Choroidal Neovascularization (mCNV) 
CONTRAINDICATIONS: Ocular or periocular infections, hypersensitivity 
WARNINGS AND PRECAUTIONS: Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients 
should be monitored following the injection; increases in intraocular pressure (IOP) have been noted both pre- and 
post-intravitreal injection; there is a potential risk of arterial thromboembolic events following intravitreal use of 
VEGF inhibitors; fatal events occurred more frequently in patients with diabetic macular edema and diabetic retinopathy 
at baseline, who were treated monthly with ranibizumab compared with control 
ADVERSE REACTIONS: The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than 
control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP 
This is not the complete list of all the safety information for CIMERLI^. Please see full Prescribing Information. 
DISCLAIMER 
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. 
These statements are made on the basis of management's views and assumptions regarding future events and business 
performance at the time the statements are made. They are subject to risks and uncertainties including, but not 
confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by 
competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties 
materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted 
or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz 
undertakes no obligation to publicly revise any forward-looking statements, except as required by law. 
REFERENCES 
^1 CDC. Vision and eye health surveillance systems. Available at: https://ddt-vehss.cdc.gov/LP?Level1= 
Age-related+Macular+Degeneration+(AMD)&Level2=AMD+Prevalence&Level3= 
VEHSS+Modeled+Estimate:+Agerelated+Macular+Degeneration+(AMD)&Level4=Prevalence+of+AMD&LocationId=&DataSourceId=PREV& 
GSDataSourceId=&GSLocationId=&RiskFactorSubCatId=&IndicatorId=QAMDMR3_ALL&ShowFootnotes=true&View=NationalChartTable& 
CompareViewYear=1&CompareId=&CompareId2=&YearId=YR11&ResponseId=R3_ALL&AgeId=AGE40PLUS&GenderId=GALL&RaceId=ALLRACE& 
RiskFactorId=RFPERS&RiskFactorResponseId=RFTOT&DataValueTypeId=CRDPREV&MapClassifierId=quantile&MapClassifierCount=7& 
CountyFlag=N [Last Accessed: February 2026] 
^2 Sandoz. Sandoz receives FDA approval for Enzeevu^ (aflibercept-abzv), further strengthening US biosimilar position. 
Available at: https://www.sandoz.com/ 
sandoz-receives-fda-approval-enzeevutm-aflibercept-abzv-further-strengthening-us-biosimilar/ [Last Accessed: February 
2026] 
^3 Sandoz data on file. 
^4 Enzeevu^. Prescribing Information. Available at SOK583_BS_A_1.14.1.3_prescribing-information-Enzeevu.pdf [Last 
Accessed: February 2026] 
ABOUT SANDOZ 
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its 
Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 
million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger 
social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. 
Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes 
Calcium Sandoz in 1929, the world's first oral penicillin in 1951, and the world's first biosimilar in 2006. In 2024, 
Sandoz recorded net sales of USD 10.4 billion. 
CONTACTS 
 
Global Media Relations contacts                Investor Relations contacts 
 
[e-mail]               [e-mail] 
 
                               Craig Marks 
Alexis Kalomparis 
[phone] 
                             [phone] 
 
Gregor Rodehueser 
                               Silvia Siegfried 
                             [phone] 
[phone] 
 
US Media Relations contacts                    
 
[e-mail]                       
 
Vicki Crafton 
                               
[phone] 

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