Sandoz Group AG: 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

18.02.2026 / 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 blindness¹
• 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 2024².

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 years³. 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 diseases⁴.

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=QAMDM~R3_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]
Alexis Kalomparis [phone]	Craig Marks [phone]
Gregor Rodehueser [phone]	Silvia Siegfried [phone]
US Media Relations contacts
[e-mail]
Vicki Crafton [phone]

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End of Media Release
View original content: EQS News

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Language:	English
Company:	Sandoz Group AG
	Centralbahnstrasse 4
	4051 Basel
	Switzerland
Internet:	www.sandoz.com
ISIN:	CH1243598427
Valor:	124359842
Listed:	SIX Swiss Exchange
EQS News ID:	2277560

End of News	EQS News Service

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2277560 18.02.2026 CET/CEST