What it is and what it is used for

for

Eydenzelt is a solution which is injected into the eye to treat eye conditions in adults called –

neovascular (wet) age-related macular degeneration (wet AMD), impaired vision due to macular oedema secondary to retinal vein occlusion (branch RVO (BRVO) or central RVO (CRVO)), impaired vision due to diabetic macular oedema (DME), impaired vision due to myopic choroidal neovascularisation (myopic CNV).

Aflibercept, the active substance in Eydenzelt, blocks the activity of a group of factors, known as Vascular Endothelial Growth Factor A (VEGF-A) and Placental Growth Factor (PlGF). In patients with wet AMD and myopic CNV, these factors, in excess are involved in the abnormal formation of new blood vessels in the eye. These new blood vessels can cause the leak of blood components into the eye and eventual damage to tissues in the eye responsible for vision. In patients with CRVO, a blockage occurs in the main blood vessel that transports blood away from the retina. VEGF levels are elevated in response causing the leakage of fluid into the retina and thereby causing a swelling of the macula, (the portion of the retina responsible for fine vision), which is called macular oedema. When the macula swells with fluid, central vision becomes blurry. In patients with BRVO, one or more branches of the main blood vessel that transports blood away from the retina is blocked. VEGF levels are elevated in response causing the leakage of fluid into the retina and thereby causing macular oedema. Diabetic macular oedema is a swelling of the retina occurring in patients with diabetes due to leaking of fluid from blood vessels within the macula. The macula is the portion of retina responsible for fine vision. When the macula swells with fluid, central vision becomes blurry. 1

Aflibercept has been shown to stop the growth of new abnormal blood vessels in the eye which often leak fluid or bleed. Eydenzelt can help to stabilise, and in many cases, improve the vision loss related to wet AMD, CRVO, BRVO, DME and myopic CNV. 2.

What you need to know before you take it

Eydenzelt

You will not be given Eydenzelt if you are allergic to aflibercept or any of the other ingredients of this medicine (listed in section 6). if you have an active or suspected infection in or around the eye (ocular or periocular infection). if you have severe inflammation of the eye (indicated by pain or redness). Warnings and precautions Talk to your doctor before you are given Eydenzelt: –

if you have glaucoma. if you have a history of seeing flashes of light or floaters and if you have a sudden increase of size and number of floaters. if surgery was performed or is planned on your eye within the previous or next four weeks. if you have a severe form of CRVO or BRVO (ischaemic CRVO or BRVO), treatment with Eydenzelt is not recommended.

Furthermore, it is important for you to know that: –

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the safety and efficacy of Eydenzelt when administered to both eyes at the same time has not been studied and if used in this way may lead to an increased risk of experiencing side effects. injections with Eydenzelt may cause an increase in eye pressure (intraocular pressure) in some patients within 60 minutes of the injection. Your doctor will monitor this after each injection. if you develop an infection or inflammation inside the eye (endophthalmitis) or other complications, you may have eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, and increased sensitivity to light. It is important to have any symptoms diagnosed and treated as soon as possible. your doctor will check whether you have other risk factors that may increase the chance of a tear or detachment of one of the layers at the back of the eye (retinal detachment or tear, and retinal pigment epithelial detachment or tear), in which case Eydenzelt must be given with caution. Eydenzelt should not be used in pregnancy unless the potential benefit outweighs the potential risk to the unborn child. women of childbearing potential have to use effective contraception during treatment and for at least three further months after the last injection of Eydenzelt.

The systemic use of VEGF inhibitors, substances similar to those contained in Eydenzelt, is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events) which may lead to heart attack or stroke. There is a theoretical risk of such events following injection of Eydenzelt into the eye. There are limited data on safety in treating patients with CRVO, BRVO, DME and myopic CNV who have had a stroke or a mini-stroke (transient ischaemic attack) or a heart attack within the last 6 months. If any of these apply to you, Eydenzelt will be given with caution. There is only limited experience in the treatment of patients with DME due to type I diabetes. diabetics with very high average blood sugar values (HbA1c over 12%). diabetics with an eye disease caused by diabetes called proliferative diabetic retinopathy.

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There is no experience in the treatment of patients with acute infections. patients with other eye conditions such as a detachment of the retina or a hole in the macula. diabetics with uncontrolled high blood pressure. non-Asian patients with myopic CNV. patients previously treated for myopic CNV. patients with damage outside the central part of the macula (extrafoveal lesions) for myopic CNV. If any of the above applies to you, your doctor will consider this lack of information when treating you with Eydenzelt. Children and adolescents The use of Eydenzelt in children or adolescents under 18 has not been studied because wet AMD, CRVO, BRVO, DME and myopic CNV occur mainly in adults. Therefore, its use in this age group is not relevant. Other medicines and Eydenzelt Tell your doctor if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding Women of childbearing potential have to use effective contraception during treatment and for at least three further months after the last injection of Eydenzelt. There is no experience of using Eydenzelt in pregnant women. Eydenzelt should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child. If you are pregnant or planning to become pregnant, discuss this with your doctor before treatment with Eydenzelt. Small amounts of Eydenzelt may pass into human milk. The effects on breast-fed newborns/infants are unknown. Eydenzelt is not recommended during breast-feeding. If you are a breastfeeding woman, discuss this with your doctor before treatment with Eydenzelt. Driving and using machines After your injection with Eydenzelt, you may experience some temporary visual disturbances. Do not drive or use machines as long as these last. Eydenzelt contains

• less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
• 0.015 mg of polysorbate 20 in each 0.05 mL per dose, which is equivalent to 0.3 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies 3.

How to take it

Eydenzelt

A healthcare professional experienced in giving eye injections will inject Eydenzelt into your eye under aseptic (clean and sterile) conditions. The recommended dose is 2 mg aflibercept (0.05 mL). Eydenzelt is given as an injection into your eye (intravitreal injection). Before the injection your healthcare professional will use a disinfectant eyewash to clean your eye carefully to prevent infection. Your healthcare professional will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection. wet AMD Patients with wet AMD will be treated with one injection per month for three consecutive doses, followed by another injection after a further two months. 3

Your doctor will then decide whether the treatment interval between injections may be kept at every two months or be gradually extended in 2- or 4-weekly intervals if your condition has been stable. If your condition worsens, the interval between injections can be shortened. Unless you experience any problems or are advised differently by your doctor, there is no need for you to see your doctor between the injections. Macular oedema secondary to RVO (branch RVO or central RVO) Your doctor will determine the most appropriate treatment schedule for you. You will start your treatment with a series of monthly Eydenzelt injections. The interval between two injections should not be shorter than one month. Your doctor may decide to stop treatment with Eydenzelt, if you are not benefiting from continued treatment. Your treatment will continue with monthly injections until your condition is stable. Three or more monthly injections may be needed. Your doctor will monitor your response to treatment and may continue your treatment by gradually increasing the interval between your injections to maintain a stable condition. If your condition starts to worsen with a longer treatment interval, your doctor will shorten the interval accordingly. Based on your response to treatment your doctor will decide on the schedule for follow up examinations and treatments. Diabetic macular oedema (DME) Patients with DME will be treated with one injection per month for the first five consecutive doses followed by one injection every two months thereafter. Treatment interval may be kept at every two months or adjusted to your condition, based on your doctor's examination. Your doctor will decide on the schedule for follow up examinations. Your doctor may decide to stop treatment with Eydenzelt if it is determined that you are not benefiting from continued treatment. Myopic CNV Patients with myopic CNV will be treated with one single injection. You will receive further injections only if your doctor's examinations reveal that your condition has not improved. The interval between two injections should not be shorter than one month. If your condition goes away and then comes back, your doctor may re-start the treatment. Your doctor will decide on the schedule for follow up examinations. If a dose of Eydenzelt is missed Make a new appointment for an examination and injection. Stopping treatment with Eydenzelt Consult your doctor before stopping the treatment. If you have any further questions on the use of this medicine, ask your doctor. 4

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Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions (hypersensitivity) could potentially occur. These may be serious and require that you contact your doctor immediately. With administration of Eydenzelt, there may be some side effects affecting the eyes which are due to the injection procedure. Some of these may be serious and include blindness, a serious infection or inflammation inside the eye (endophthalmitis), detachment, tear or bleeding of the light-sensitive layer at the back of the eye (retinal detachment or tear), clouding of the lens (cataract), bleeding in the eye (vitreous haemorrhage), detachment of the gel-like substance inside the eye from the retina (vitreous detachment) and increase of pressure inside the eye, see section 2. These serious side effects affecting the eyes occurred in less than 1 in 1,900 injections in clinical studies. If you experience a sudden decrease in vision, or an increase in pain and redness in your eye after your injection, contact your doctor immediately. List of side effects reported The following is a list of the side effects reported to be possibly related to the injection procedure or to the medicine. Please do not get alarmed, you might not experience any of these. Always discuss any suspected side effects with your doctor. Very common side effects (may affect more than 1 in 10 people): deterioration of eyesight bleeding in the back of the eye (retinal haemorrhage) bloodshot eye caused by bleeding from small blood vessels in the outer layers of the eye eye pain Common side effects (may affect up to 1 in 10 people): detachment or tear of one of the layers in the back of the eye, resulting in flashes of light with floaters sometimes progressing to a loss of vision (retinal pigment epithelial tear*/detachment, retinal detachment/tear) degeneration of the retina (causing disturbed vision) bleeding in the eye (vitreous haemorrhage) certain forms of clouding of the lens (cataract) damage to the front layer of the eyeball (the cornea) increase in eye pressure moving spots in vision (floaters) detachment of the gel-like substance inside the eye from the retina (vitreous detachment, resulting in flashes of light with floaters) a feeling of having something in the eye increased tear production swelling of the eyelid bleeding at the injection site redness of the eye

• Conditions known to be associated with wet AMD; observed in wet AMD patients only.

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Uncommon side effects (may affect up to 1 in 100 people): allergic reactions (hypersensitivity)** serious inflammation or infection inside the eye (endophthalmitis) inflammation in the iris or other parts of the eye (iritis, uveitis, iridocyclitis, anterior chamber flare) abnormal sensation in the eye eyelid irritation swelling of the front layer of the eyeball (cornea) ** Allergic reactions like rash, itching (pruritus), hives (urticaria), and a few cases of severe allergy (anaphylactic/anaphylactoid) reactions were reported. Rare side effects (may affect up to 1 in 1 000 people): blindness clouding of the lens due to injury (traumatic cataract) inflammation of the gel-like substance inside the eye pus in the eye Not known (frequency cannot be estimated from the available data): inflammation of the white part of the eye associated with redness and pain (scleritis) In the clinical trials, there was an increased incidence of bleeding from small blood vessels in the outer layers of the eye (conjunctival haemorrhage) in patients with wet AMD receiving blood thinners. This increased incidence was comparable between patients treated with ranibizumab and aflibercept. The systemic use of VEGF inhibitors, substances similar to those contained in Eydenzelt, is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events) which may lead to heart attack or stroke. There is a theoretical risk of such events following injection of Eydenzelt into the eye. As with all therapeutic proteins, there is a possibility for an immune reaction (formation of antibodies) with Eydenzelt. Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.

How to store it

Eydenzelt

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Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 °C – 8 °C). Do not freeze. The unopened vial may be stored outside the refrigerator below 25 °C for up to 31 days. Keep the vial in the outer carton in order to protect from light. If this medicine becomes discoloured or shows any other signs of deterioration, please contact your pharmacist who will advise you on what to do. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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Contents of the pack and other information

What Eydenzelt contains The active substance is: aflibercept. One vial contains an extractable volume of at least 0.1 mL, equivalent to at least 4 mg aflibercept. One vial delivers a dose of 2 mg aflibercept in 0.05 mL. The other ingredients are: polysorbate 20 (E 432), Histidine (for pH adjustment), histidine hydrochloride monohydrate (for pH adjustment), sodium chloride, trehalose, water for injections. 6

See 'Eydenzelt contains' in section 2 for more information. What Eydenzelt looks like and contents of the pack Eydenzelt is a solution for injection (injection) in a vial. The solution is clear to slightly opalescent, and colourless to very pale brownish-yellow. Pack size of 1 vial + 1 filter needle. Marketing Authorisation Holder Celltrion Healthcare United Kingdom Limited The Charter Building, Charter Place, Uxbridge UB8 1JG United Kingdom Manufacturer Nuvisan France SARL 2400, Route des Colles, 06410, Biot, France Midas Pharma GmbH Rheinstr. 49, 55218 Ingelheim, Germany KYMOS S.L. Ronda Can Fatjó, 7B. 08290 Cerdanyola del Vallès, Barcelona, Spain For any information about this medicine, please contact the Marketing Authorisation Holder: United Kingdom Celltrion Healthcare United Kingdom Limited Tel: +44 (0)1753 983500

This leaflet was last revised in 11/2025.

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The following information is intended for healthcare professionals only: The vial should only be used for the treatment of a single eye. The vial contains more than the recommended dose of 2 mg aflibercept (equivalent to 0.05 mL). The excess volume must be discarded prior to administration. The solution should be inspected visually for any foreign particulate matter and/or discolouration or any variation in physical appearance prior to administration. In the event of either being observed, discard the medicinal product. The unopened vial may be stored outside the refrigerator below 25 °C for up to 31 days. After opening the vial, proceed under aseptic conditions. The vial content is to be injected into a patient immediately after withdrawal with the syringe. For the intravitreal injection, a 30 G x 1⁄2 inch injection needle should be used. Instructions for use of vial: Supplies: Eydenzelt vial kit includes the following single use materials (see Figure A).  18 G x 1 1⁄2 inch, 5 micron sterile filter needle  Vial

Figure A Supplies not included in the kit:  30 G x 1⁄2 inch injection needle  1 mL Luer lock Syringe 1. Gather your supplies. Using aseptic technique, gather your supplies and place them on a clean, flat surface. 2. Inspect Eydenzelt. Look at the vial and make sure you have the correct medicine (Eydenzelt) and dosage. Check the expiration date on the label (see Figure B) to make sure it has not passed.  Do not use Eydenzelt if particulates, cloudiness, or discoloration are visible.  Do not use if the expiration date has passed. Figure B

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3. Remove the protective plastic cap from the vial (see Figure C).

Figure C 4. Disinfect the outer part of the rubber stopper of the vial with an alcohol wipe (see Figure D)

Figure D 5. Attach the filter needle to the syringe. Remove the 18 G × 1 1⁄2-inch, 5-micron filter needle, supplied in the carton, and a 1 mL Luer lock syringe, not included in the carton, from their packaging. Attach the filter needle to the syringe by twisting it onto the Luer lock syringe tip (see Figure E)

Figure E

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6. Insert the filter needle into the vial 6a. Using aseptic technique, push the filter needle into the center of the vial stopper until the needle is completely inserted into the vial, and the tip touches the bottom or bottom edge of the vial. 6b. Tilt the vial during withdrawal, keeping the bevel of the filter needle submerged in the liquid (see Figure F) to deter the introduction of air. 6c. Withdraw all of the Eydenzelt vial contents into the syringe. Note: Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle. Figure F 7. Remove the filter needle. Remove the filter needle from the syringe. Properly dispose the filter needle.  Do not use the filter needle for intravitreal injection.  Do not recap the filter needle to prevent pre-injection needle sticks. 8. Attach the injection needle to the syringe (to be done immediately after withdrawal of the vial content). Remove the 30 G × 1⁄2-inch injection needle, not included in the carton, from its packaging. Using aseptic technique, attach the injection needle to the syringe by firmly twisting the injection needle onto the Luer lock syringe tip (see Figure G).

Figure G

9. Check for air bubbles. Holding the syringe with the injection needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure H).

Figure H

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10. Remove air bubbles and confirm correct dose. To remove all of the bubbles and to expel excess drug, SLOWLY depress the plunger so that the plunger edge aligns with the line that marks 0.05 mL on the syringe (see Figure I).

Figure I 11. When ready to administer Eydenzelt, remove the plastic needle cap from the needle (see Figure J).

Figure J

12. When ready, complete the intravitreal injection. The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include surgical hand disinfection and the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a topical broad-spectrum microbicide should be given prior to the injection. Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before Eydenzelt is administered to the other eye. 13. The vial is for single-use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Extraction of multiple doses from a single vial may increase the risk of contamination and subsequent infection. 14. After the injection, monitor the patient. Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, a sterile paracentesis needle should be available. Following intravitreal injection, patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye pain, redness of the eye, photophobia, blurring of vision) without delay.

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