Eiyzey

Patient Information Leaflet

Eiyzey 40 mg/mL solution for injection in a pre-filled syringe

aflibercept
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet

1. What Eiyzey is and what it is used for
2. What you need to know before using Eiyzey
3. How to use Eiyzey
4. Possible side effects
5. How to store Eiyzey
6. Contents of the pack and other information

1. What Eiyzey is and what it is used for

Eiyzey is a solution injected into the eye to treat eye diseases in adults called

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

Aflibercept, the active substance in Eiyzey, blocks the activity of a group of factors known as VEGF-A (Vascular Endothelial Growth Factor A) and PlGF (Placental Growth Factor).
In patients with wet AMD and myopic CNV, these factors, when present in excess, are involved in the abnormal formation of new blood vessels in the eye. The new blood vessels can leak blood components into the eye and potentially damage ocular tissues responsible for vision.
In patients with CRVO, a blockage forms in the main blood vessel that carries blood away from the retina. In response to this event, VEGF levels increase, causing fluid leakage into the retina and thus leading to swelling of the macula (the part of the retina responsible for sharp vision), known as macular oedema. When the macula swells with fluid, central vision becomes blurred.
In patients with BRVO, one or more branches of the main blood vessel draining blood from the retina are blocked. VEGF levels consequently rise and cause fluid leakage into the retina, resulting in macular oedema.
Diabetic macular oedema is a swelling of the retina that occurs in diabetic patients due to leakage of fluid from blood vessels in the macula. The macula is the part of the retina responsible for clear vision. When the macula fills with fluid, central vision becomes blurred.
Eiyzey has been shown to block the growth of abnormal new blood vessels in the eye, which often leak fluid or blood. Eiyzey may help stabilise and, in many cases, improve vision loss associated with wet AMD, CRVO, BRVO, DME, and myopic CNV.

2. What you should know before using Eiyzey

Do not take Eiyzey

• if you are allergic to aflibercept or to any of the other ingredients of this medicine (listed in section 6).
• if you currently have or suspect an infection inside 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 taking Eiyzey

• if you have glaucoma.
• if you have ever experienced flashes of light or floaters, or if the number and size of floaters has suddenly increased.
• if you have had or are scheduled to have eye surgery within the past or next four weeks.
• if you have a severe form of CRVO or BRVO (ischaemic CRVO or BRVO), treatment with Eiyzey is not recommended.

It is also important for you to know that

• the safety and efficacy of Eiyzey when administered in both eyes simultaneously have not been studied, and if administered in this way, it may increase the risk of adverse effects.
• in some patients, Eiyzey injections may cause an increase in intraocular pressure (intraocular pressure) within 60 minutes after injection. Your doctor will monitor for this effect after each injection.
• if you develop an infection or inflammation inside the eye (endophthalmitis) or other complications, you may experience eye pain or increased discomfort, worsening eye redness, vision loss, or increased sensitivity to light. It is important that any symptoms are diagnosed and treated as soon as possible.
• your doctor will check for other risk factors that may increase the likelihood of detachment or rupture of one of the layers in the back of the eye (retinal detachment or tear, and retinal pigment epithelial detachment or tear); in such cases, Eiyzey will be administered with caution.
• Eiyzey must not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
• women of childbearing potential must use effective contraception during treatment and for at least three additional months after the last injection of Eiyzey.

Systemic use of VEGF inhibitors—substances similar to those contained in Eiyzey—is potentially associated with the risk of blood clots blocking blood vessels (arterial thromboembolic events), leading to heart attack or stroke. There is a theoretical risk that such events may occur following injection of Eiyzey into the eye. Data on the safety of treating patients with CRVO, BRVO, DME, and myopic CNV who have had a stroke or mini-stroke (transient ischaemic attack) or heart attack within the past 6 months are limited. If any of these situations apply to you, Eiyzey will be administered with caution.

Experience is limited with treatment of

• patients with DME due to type I diabetes.
• diabetic patients with high average blood glucose levels (HbA1c greater than 12%).
• diabetic patients with a diabetes-related eye disease called proliferative diabetic retinopathy.

There is no experience with treatment of

• patients with acute infections.
• patients with other eye diseases such as retinal detachment or macular hole.
• diabetic patients with uncontrolled high blood pressure.
• non-Asian patients with myopic CNV.
• patients previously treated for myopic CNV.
• patients with lesions located outside the central part of the macula (extrafoveal lesions) for myopic CNV.

If you fall into any of the above categories, your doctor will take into account this lack of information when treating you with Eiyzey.

Children and adolescents
In children and adolescents under 18 years of age, the use of Eiyzey has not been studied.

Other medicines and Eiyzey
Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

• Women of childbearing potential must use effective contraception during treatment and for at least three months after the last injection of Eiyzey.
• There is no experience with the use of Eiyzey in pregnant women. Eiyzey must 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 Eiyzey.
• Small amounts of Eiyzey may pass into breast milk. The effects on breastfed infants/infants are unknown. Eiyzey is not recommended during breastfeeding. If you are breastfeeding, discuss this with your doctor before treatment with Eiyzey.

Driving and using machines
After injection of Eiyzey, you may experience temporary visual disturbances. Do not drive or operate machinery until these disturbances have resolved.

Important information about some ingredients of Eiyzey
This medicine contains

• less than 1 mmol (23 mg) of sodium per single dose, i.e., it is essentially 'sodium-free'.
• in each 0.05 mL dose, 0.015 mg of polysorbate 20, equivalent to 0.3 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Eiyzey

A doctor experienced in eye injections will inject Eiyzey into your eye under aseptic (clean and sterile) conditions.
The recommended dose is 2 mg of aflibercept (0.05 mL).
Eiyzey is administered as an injection into the eye (intravitreal injection).
Before the injection, the doctor will use a disinfecting eye wash to thoroughly clean your eye and prevent infections. The doctor will also give you a local anaesthetic to reduce or block pain caused by 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 an additional 2 months.
Your doctor will then decide whether the treatment interval between injections can be maintained every two months or, if your condition remains stable, gradually extended to intervals of 2 or 4 weeks.
If your condition worsens, the interval between injections may be shortened.
Unless you experience problems or are otherwise advised by your doctor, there is no need for medical visits during the period between injections.

Macular oedema secondary to RVO (branch RVO and central RVO)
Your doctor will determine the most appropriate treatment frequency for you. Treatment will begin with a series of monthly Eiyzey injections.
The interval between two injections must not be less than one month.
If you have not benefited after continued treatment, your doctor may decide to discontinue treatment with Eiyzey.
Treatment will continue with monthly injections until your condition stabilises.
Three or more monthly injections may be necessary.
Your doctor will monitor your response to treatment and may continue treatment with a gradual increase in the intervals between injections to maintain a stable condition. If your condition begins to worsen when extending the interval between treatments, your doctor will shorten the treatment intervals accordingly.
Based on your individual response to treatment, your doctor will decide when follow-up examinations and treatments should be scheduled.

Diabetic macular oedema (DME)
Patients with DME will be treated with one injection per month for the first five consecutive doses, followed by an injection every 2 months.
Based on examinations performed by your doctor, the interval between treatments may be maintained every 2 months or adjusted according to your condition. Your doctor will decide the frequency of follow-up examinations.
Your doctor may decide to discontinue treatment with Eiyzey if it becomes evident that you are not benefiting from continuing the treatment.

Myopic CNV
Patients with myopic CNV will be treated with a single injection. You will receive further injections only if examinations performed by your doctor indicate that the disease has not improved.
The interval between two injections must not be less than one month.
If the disease resolves and then recurs, your doctor may restart treatment.
Your doctor will determine the schedule for follow-up examinations.

Detailed instructions for use are included at the end of the package leaflet in the section “How to prepare and administer Eiyzey”.

If you forget to use Eiyzey
Make a new appointment for examinations and injection.

If you stop treatment with Eiyzey
Consult your doctor before stopping treatment.
If you have any doubts about how to use this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (hypersensitivity) may potentially occur, which can be serious
and require immediate medical attention.
When Eiyzey is administered, certain side effects affecting the eyes may occur, which are related to the injection procedure. Some of these may be serious and include blindness, a severe infection or inflammation inside the eye (endophthalmitis), detachment,
tearing or bleeding of the light-sensitive layer at the back of the eye (retinal detachment or tear), clouding of the lens (cataract), bleeding inside the eye (vitreous haemorrhage), separation of the gel-like substance inside the eye from the retina (vitreous detachment), and increased pressure inside the eye – see section 2.
In clinical studies, these serious eye-related side effects occurred in fewer than 1 out of 1,900 injections.

If you experience a sudden decrease in vision, or increased eye pain and redness after the injection, contact your doctor immediately.
List of reported side effects
Below is a list of side effects reported as potentially related to the injection procedure or the medicine. Do not be alarmed – you may not experience any of these. Always talk to your doctor about any suspected side effects.
Very common side effects (may affect more than 1 in 10 people):

• worsening of vision
• bleeding in the back of the eye (retinal haemorrhage)
• bloodshot eye due to 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 rupture of one of the layers at the back of the eye, causing flashes of light with floaters and sometimes leading to vision loss (retinal pigment epithelial tear*, detachment, retinal detachment/tear) or *Conditions known to be associated with neovascular age-related macular degeneration (wet AMD), observed only in patients with wet AMD.
• retinal degeneration causing disturbed vision
• bleeding into the eye (vitreous haemorrhage)
• certain forms of clouding of the lens (cataract)
• damage to the outermost layer of the eyeball (the cornea)
• increased intraocular pressure
• seeing moving spots (floaters)
• separation of the gel-like substance inside the eye from the retina (vitreous detachment, causing flashes of light with floaters)
• sensation of having something in the eye
• increased tear production
• eyelid swelling
• bleeding at the injection site
• eye redness

Uncommon side effects (may affect up to 1 in 100 people):

• allergic reactions (hypersensitivity)** or **Allergic reactions such as skin rash, itching, urticaria, and some cases of severe allergic reaction (anaphylactic/anaphylactoid) have been reported.
• severe inflammation or infection inside the eye (endophthalmitis)
• inflammation of the iris or other parts of the eye (iritis, uveitis, iridocyclitis, flare in the anterior chamber)
• unusual sensation in the eye
• eyelid irritation
• swelling of the outermost layer of the eyeball (cornea)

Rare side effects (may affect up to 1 in 1,000 people):

• blindness
• clouding of the lens following 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 clinical studies of patients with age-related wet macular degeneration (AMD) treated with blood-thinning medicines, an increased incidence of bleeding from small blood vessels in the outer layer of the eye (conjunctival haemorrhage) was observed. This increased incidence was comparable between patients treated with ranibizumab and those treated with aflibercept.
Systemic use of vascular endothelial growth factor (VEGF) inhibitors, which are substances similar to those contained in Eiyzey, is potentially associated with the risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. There is a theoretical risk that such events could occur following the injection of aflibercept into the eye.
As with all therapeutic proteins, treatment with aflibercept may trigger an immune response (antibody formation).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor. You may also report side effects directly through the National Reporting System listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eiyzey

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and label following “Exp.” / “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 blister can be stored outside the refrigerator at a temperature below 25 °C for up to 24 hours.
• Keep in the original packaging to protect from light.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eiyzey contains

• The active substance is aflibercept. Each pre-filled syringe contains 6.6 mg of aflibercept in 0.165 mL of solution. This provides a usable volume for administration of a single dose of 0.05 mL containing 2 mg of aflibercept.
• The other components are: sodium acetate trihydrate, acetic acid (glacial) 100%, sucrose, sodium chloride, polysorbate 20 (E432), water for injections.

See 'Eiyzey contains' in section 2 for more information.
Description of the appearance of Eiyzey and contents of the pack
Eiyzey is an injectable solution (preparation for injection) in a pre-filled syringe. The solution is colourless to pale yellow.
Single-dose 1 mL pre-filled syringe with Luer-lock (SPR; fill volume: 165 microlitres of solution) made of cyclic olefin polymer (COP), with a chlorobutyl rubber tip cap. The syringe is closed with a chlorobutyl rubber plunger stopper coated with cross-linked silicone. Each carton contains one SPR containing a nominal volume of 165 microlitres of solution for intravitreal injection.
Pack: 1 pre-filled syringe.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Poland
Manufacturer
KYMOS S.L.
Ronda De Can Fatjó 7b
Parc Tecnològic Del Vallès Cerdanyola Del Vallès
Barcelona
Spain
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België / Belgique / Belgien Lietuva
OmniVision GmbH OmniVision GmbH
Tél/Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
България Luxembourg / Luxemburg
OmniVision GmbH OmniVision GmbH
Teл.: +49 89 840 792 30 Tél/Tel: +49 89 840 792 30
Česká republika Magyarország
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Danmark Malta
OmniVision GmbH OmniVision GmbH
Tlf.: +49 89 840 792 30 Tel: +49 89 840 792 30
Deutschland Nederland
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Eesti Norge
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tlf: +49 89 840 792 30
Ελλάδα Österreich
OmniVision GmbH OmniVision GmbH
Τηλ: +49 89 840 792 30 Tel: +49 89 840 792 30
España Polska
OmniVision Farma España S.L. OmniVision GmbH
Tel: +34 93 747 10 29 Tel: +49 89 840 792 30
France Portugal
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Hrvatska România
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Ireland Slovenija
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Ísland Slovenská republika
OmniVision GmbH OmniVision GmbH
Sími: +49 89 840 792 30 Tel: +49 89 840 792 30
Italia Suomi/Finland
OmniVision Italia S.r.l. OmniVision GmbH
Tel.: +39 02 308 90 93 Puh/Tel: +49 89 840 792 30
Κύπρος Sverige
OmniVision GmbH OmniVision GmbH
Τηλ: +49 89 840 792 30 Tel: +49 89 840 792 30
Latvija
OmniVision GmbH
Tel: +49 89 840 792 30
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu .

The following information is intended exclusively for healthcare professionals:

How to prepare and administer Eiyzey
The pre-filled syringe must be used only for the treatment of a single eye.
Do not open the sterile syringe blister pack outside the clean administration room.
The pre-filled syringe contains more than the recommended dose of 2 mg aflibercept (equivalent to 0.05 mL). The excess volume must be discarded prior to administration.
Before administration, visually inspect the injectable solution for the presence of foreign particles and/or discoloration or any change in appearance. If any of these are observed, the product must be discarded.
The sealed blister may be stored outside the refrigerator at a temperature not exceeding 25°C for up to 24 hours. Once the blister is opened, proceed under aseptic conditions. A 30 G x ½ inch injection needle must be used for intravitreal injection.
Instructions for using the pre-filled syringe:

Package leaflet: information for the patient

Eiyzey 40 mg/mL solution for injection in vial

aflibercept
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

1. What Eiyzey is and what it is used for
2. What you need to know before using Eiyzey
3. How to use Eiyzey
4. Possible side effects
5. How to store Eiyzey
6. Contents of the pack and other information

1. What Eiyzey is and what it is used for

Eiyzey is a solution injected into the eye to treat eye diseases in adults called

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

Aflibercept, the active substance in Eiyzey, blocks the activity of a group of factors known as VEGF-A (vascular endothelial growth factor A) and PlGF (placental growth factor).
In patients with wet AMD and myopic CNV, these factors, when present in excess, are involved in the abnormal formation of new blood vessels in the eye. The new blood vessels may leak blood components into the eye and potentially damage ocular tissues responsible for vision.
In patients with CRVO, a blockage forms in the main blood vessel that carries blood away from the retina. In response to this event, VEGF levels increase, causing fluid leakage into the retina and resulting in swelling of the macula (the part of the retina responsible for sharp vision), known as macular oedema. When the macula swells with fluid, central vision becomes blurred.
In patients with BRVO, one or more branches of the main blood vessel draining blood from the retina are blocked. VEGF levels consequently rise, leading to fluid leakage into the retina and causing macular oedema.
Diabetic macular oedema is a swelling of the retina that occurs in diabetic patients due to leakage of fluid from blood vessels in the macula. The macula is the part of the retina responsible for clear vision. When the macula fills with fluid, central vision becomes blurred.
Eiyzey has been shown to block the growth of abnormal new blood vessels in the eye, which often leak fluid or blood. Eiyzey may help to stabilise, and in many cases improve, vision loss associated with wet AMD, CRVO, BRVO, DMO, and myopic CNV.

2. What you should know before using Eiyzey

Do not take Eiyzey

• if you are allergic to aflibercept or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have or suspect an infection inside or around your 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 receiving Eiyzey:

• if you have glaucoma;
• if you have ever experienced flashes of light or floaters, or if the number and size of floaters have suddenly increased;
• if you have had or are scheduled to have eye surgery within the past or next four weeks;
• if you have a severe form of CRVO or BRVO (ischemic CRVO or BRVO), treatment with Eiyzey is not recommended.

It is also important for you to know that:

• the safety and efficacy of Eiyzey have not been studied when administered in both eyes simultaneously; administering it in this way may increase the risk of adverse effects.
• in some patients, Eiyzey injections may cause a temporary increase in intraocular pressure within 60 minutes after injection. Your doctor will monitor for this effect after each injection.
• if you develop an infection or inflammation inside the eye (endophthalmitis) or other complications, you may experience eye pain or increased discomfort, worsening eye redness, blurred or reduced vision, and increased sensitivity to light. It is important that any symptoms are diagnosed and treated as soon as possible.
• your doctor will check for other risk factors that may increase the likelihood of detachment or rupture of one of the layers in the back of the eye (retinal detachment or tear, or retinal pigment epithelial detachment or tear); in such cases, Eiyzey will be administered with caution.
• Eiyzey must not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
• women of childbearing potential must use effective contraception during treatment and for at least three months after the last injection of Eiyzey.

Systemic use of VEGF inhibitors—substances similar to those contained in Eiyzey—has been potentially associated with the risk of blood clots blocking blood vessels (arterial thromboembolic events), leading to heart attack or stroke. After injection of Eiyzey into the eye, there is a theoretical risk that such events could occur. Safety data are limited for treatment of patients with CRVO, BRVO, DME, and myopic CNV who have experienced a stroke or mini-stroke (transient ischemic attack) or heart attack within the previous 6 months. If any of these apply to you, Eiyzey will be administered with caution.

Experience is limited in the treatment of:

• patients with DME due to type I diabetes;
• diabetic patients with high average blood glucose levels (HbA1c greater than 12%);
• diabetic patients with a diabetes-related eye disease called proliferative diabetic retinopathy.

There is no experience with the treatment of:

• patients with acute infections;
• patients with other eye diseases such as retinal detachment or macular hole;
• diabetic patients with uncontrolled high blood pressure;
• non-Asian patients with myopic CNV;
• patients previously treated for myopic CNV;
• patients with lesions located outside the central part of the macula (extrafoveal lesions) for myopic CNV.

If you fall into any of the above categories, your doctor will take this lack of information into account when treating you with Eiyzey.

Children and adolescents
The use of Eiyzey has not been studied in children and adolescents under 18 years of age because wet AMD, CRVO, BRVO, DME, and myopic CNV occur primarily in adults. Therefore, its use in this age group is not relevant.

Other medicines and Eiyzey
Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

• Women of childbearing potential must use effective contraception during treatment and for at least three months after the last injection of Eiyzey.
• There is no experience with the use of Eiyzey in pregnant women. Eiyzey must 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 Eiyzey.
• Small amounts of Eiyzey may pass into breast milk. The effects on breastfed infants are unknown. Eiyzey is not recommended during breastfeeding. If you are breastfeeding, discuss this with your doctor before treatment with Eiyzey.

Driving and using machines
After injection of Eiyzey, you may experience temporary visual disturbances. Do not drive or operate machinery until these disturbances have resolved.

Important information on some ingredients of Eiyzey
This medicine contains:

• Eiyzey contains less than 1 mmol (23 mg) of sodium per single dose, i.e., it is essentially ‘sodium-free’.
• 0.015 mg of polysorbate 20 in each 0.05 mL dose, equivalent to 0.3 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Eiyzey

A doctor experienced in eye injections will inject Eiyzey into your eye under aseptic (clean and sterile) conditions.
The recommended dose is 2 mg of aflibercept (0.05 mL).
Eiyzey is administered as an injection into the eye (intravitreal injection).
Before the injection, the doctor will use a disinfecting eye wash to thoroughly clean your eye and prevent infections. The doctor will also give you a local anesthetic to reduce or block pain caused by the injection.

Exudative AMD
Patients with exudative AMD will be treated with one injection per month for three consecutive doses, followed by another injection after an additional two months.
Your doctor will then decide whether the treatment interval between injections can be maintained every two months or, if your condition remains stable, gradually extended to intervals of 2 or 4 weeks.
If your condition worsens, the interval between injections may be shortened.
Unless you experience problems or are otherwise advised by your doctor, there is no need for medical visits during the period between injections.

Macular edema secondary to RVO (branch RVO and central RVO)
Your doctor will determine the most appropriate treatment frequency for you. Treatment will begin with a series of monthly Eiyzey injections.
The interval between two injections must not be less than one month.
If you do not experience benefit after continued treatment, your doctor may decide to discontinue treatment with Eiyzey.
Treatment will continue with monthly injections until your condition stabilizes. Three or more monthly injections may be necessary.
Your doctor will monitor your response to treatment and may continue treatment with a gradual increase in the intervals between injections to maintain a stable condition. If, as the treatment interval is extended, your condition begins to worsen, your doctor will shorten the treatment intervals accordingly.
Based on your individual response to treatment, your doctor will decide when follow-up examinations and treatments should be scheduled.

Diabetic macular edema (DME)
Patients with DME will be treated with one injection per month for the first five consecutive doses, followed by an injection every two months.
Based on examinations performed by your doctor, the treatment interval may be maintained every two months or adjusted according to your condition. Your doctor will decide the frequency of follow-up examinations.
Your doctor may decide to discontinue treatment with aflibercept if it becomes evident that you are not benefiting from continued treatment.

Myopic CNV
Patients with myopic CNV will be treated with a single injection. You will receive additional injections only if examinations performed by your doctor indicate that the disease has not improved.
The interval between two injections must not be less than one month.
If the disease resolves and then recurs, your doctor may restart treatment.
Your doctor will establish the schedule for follow-up examinations.

If you forget to use Eiyzey
Make a new appointment for examinations and the injection.

If you interrupt treatment with Eiyzey
Consult your doctor before interrupting treatment.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (hypersensitivity) may potentially occur, which can be severe
and may require immediate medical attention.
When Eiyzey is administered, certain side effects affecting the eyes may occur, which are related to the injection procedure. Some of these may be serious and include blindness, a severe infection or inflammation inside the eye (endophthalmitis), detachment,
tearing or bleeding of the light-sensitive layer at the back of the eye (retinal detachment or tear), clouding of the lens (cataract), bleeding inside the eye (vitreous haemorrhage), separation of the gel-like substance inside the eye from the retina (vitreous detachment), and increased pressure inside the eye, see paragraph 2.
In clinical studies, these serious eye-related side effects occurred in fewer than 1 in 1,900 injections.

If you experience a sudden decrease in vision, or increased eye pain and redness after the injection, contact your doctor immediately.
List of reported side effects
Below is a list of side effects reported as potentially related to the injection procedure or the medicine. Do not be alarmed – you may not experience any of them. Always speak to your doctor about any suspected side effects.
Very common side effects (may affect more than 1 in 10 people):

• worsening of vision
• bleeding at the back of the eye (retinal haemorrhage)
• eye redness due to 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 rupture of one of the layers at the back of the eye, causing flashes of light with floaters and sometimes leading to vision loss (retinal pigment epithelial tear/detachment, retinal detachment/tear)
• degeneration of the retina (causing disturbed vision)
• bleeding in the eye (vitreous haemorrhage)
• certain forms of lens clouding (cataract)
• damage to the outermost layer of the eyeball (the cornea)
• increased eye pressure
• seeing moving spots (floaters)
• separation of the gel-like substance inside the eye from the retina (vitreous detachment, causing flashes of light with floaters)
• sensation of having something in the eye
• increased tear production
• eyelid swelling
• bleeding at the injection site
• eye redness * Conditions known to be associated with neovascular age-related macular degeneration (wet AMD), observed only in patients with wet AMD.

Uncommon side effects (may affect up to 1 in 100 people):

• allergic reactions (hypersensitivity)**
• severe inflammation or infection inside the eye (endophthalmitis)
• inflammation of the iris or other parts of the eye (iritis, uveitis, iridocyclitis, flare in the anterior chamber)
• unusual sensation in the eye
• eyelid irritation
• swelling of the outermost layer of the eyeball (cornea) ** Allergic reactions reported include skin rashes, itching, urticaria, and some cases of severe allergic reaction (anaphylactic/anaphylactoid).

Rare side effects (may affect up to 1 in 1,000 people):

• blindness
• clouding of the lens following 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 clinical studies of patients with age-related neovascular macular degeneration (AMD) treated with blood-thinning medicines, an increased incidence of bleeding from small blood vessels in the outer layer of the eye (conjunctival haemorrhage) was observed. This increased incidence was similar between patients treated with ranibizumab and those treated with aflibercept.
Systemic use of vascular endothelial growth factor (VEGF) inhibitors, which are substances similar to those contained in Eiyzey, is potentially associated with the risk of blood clots blocking blood vessels (arterial thromboembolic events) that may lead to heart attack or stroke. There is a theoretical risk that such events may occur following aflibercept injection into the eye.
As with all therapeutic proteins, aflibercept may trigger an immune response (antibody formation).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the National Reporting System listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eiyzey

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and label after "Exp." / "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 at a temperature below 25 °C for up to 24 hours.
• Store in the original packaging to protect the medicine from light.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eiyzey contains

• The active substance is aflibercept. Each vial contains 11.12 mg of aflibercept in 0.278 mL of solution. This provides a usable amount for administration of a single dose of 0.05 mL containing 2 mg of aflibercept.
• The other components are: polysorbate 20 (E432), sodium acetate trihydrate, glacial acetic acid 100%, sodium chloride, sucrose, water for injections.

See 'Eiyzey contains' in section 2 for further information.
Description of the appearance of Eiyzey and package contents
Eiyzey is an injectable solution (injection preparation) in a vial. The solution appears colourless to pale yellow.
Pack: 1 vial + 1 filter needle.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Poland
Manufacturer
KYMOS S.L.
Ronda De Can Fatjó 7b
Parc Tecnològic Del Vallès Cerdanyola Del Vallès
Barcelona
Spain
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België / Belgique / Belgien Lietuva
OmniVision GmbH OmniVision GmbH
Tél/Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
България Luxembourg / Luxemburg
OmniVision GmbH OmniVision GmbH
Teл.: +49 89 840 792 30 Tél/Tel: +49 89 840 792 30
Česká republika Magyarország
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Danmark Malta
OmniVision GmbH OmniVision GmbH
Tlf.: +49 89 840 792 30 Tel: +49 89 840 792 30
Deutschland Nederland
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Eesti Norge
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tlf: +49 89 840 792 30
Ελλάδα Österreich
OmniVision GmbH OmniVision GmbH
Τηλ: +49 89 840 792 30 Tel: +49 89 840 792 30
España Polska
OmniVision Farma España S.L. OmniVision GmbH
Tel: +34 93 747 10 29 Tel: +49 89 840 792 30
France Portugal
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Hrvatska România
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Ireland Slovenija
OmniVision GmbH OmniVision GmbH
Tel: +49 89 840 792 30 Tel: +49 89 840 792 30
Ísland Slovenská republika
OmniVision GmbH OmniVision GmbH
Sími: +49 89 840 792 30 Tel: +49 89 840 792 30
Italia Suomi/Finland
OmniVision Italia S.r.l. OmniVision GmbH
Tel.: +39 02 308 90 93 Puh/Tel: +49 89 840 792 30
Κύπρος Sverige
OmniVision GmbH OmniVision GmbH
Τηλ: +49 89 840 792 30 Tel: +49 89 840 792 30
Latvija
OmniVision GmbH
Tel: +49 89 840 792 30
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

The following information is intended exclusively for healthcare professionals:

The vial must be used only 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.
Before administration, visually inspect the injectable solution for the presence of foreign particles and/or discoloration or any change in appearance. If this occurs, the product must be discarded.
The unopened vial may be stored outside the refrigerator at a temperature below 25°C for up to 24 hours. Once the vial is opened, handle under aseptic conditions.
For intravitreal injection, a 30 G x ½ inch injection needle must be used.
Instructions for use of the vial: