Lytenava: Uses, Dosage & Side Effects

What Is Lytenava and What Is It Used For?

Lytenava contains the active substance bevacizumab gamma, a humanized monoclonal antibody (IgG1) produced using recombinant DNA technology. Bevacizumab is one of the most extensively studied anti-VEGF agents in medicine, having been used in oncology since 2004 (as Avastin) and in ophthalmology off-label for nearly two decades. Lytenava represents a landmark development as the first dedicated ophthalmic formulation of bevacizumab to receive a regulatory marketing authorisation specifically for intravitreal use in the treatment of wet AMD.

Age-related macular degeneration (AMD) is the leading cause of irreversible central vision loss in adults over 50 in industrialised countries. The condition affects the macula, the central part of the retina responsible for sharp, detailed vision needed for reading, driving, and recognising faces. AMD exists in two forms: dry (atrophic) AMD, which progresses slowly and accounts for approximately 85–90% of cases, and wet (neovascular or exudative) AMD, which accounts for only 10–15% of cases but is responsible for approximately 90% of severe vision loss associated with AMD.

In wet AMD, abnormal blood vessels grow from the choroid (the vascular layer beneath the retina) through Bruch’s membrane and into the sub-retinal or sub-retinal pigment epithelium space. This process, known as choroidal neovascularisation (CNV), is driven primarily by vascular endothelial growth factor A (VEGF-A). These newly formed blood vessels are fragile and leaky, allowing blood and fluid to accumulate beneath and within the retina. This leads to retinal oedema, haemorrhage, lipid exudation, and ultimately scarring (disciform scar formation), which destroys the photoreceptor cells in the macula and causes progressive, often rapid, central vision loss.

Bevacizumab gamma works by selectively binding to all biologically active isoforms of VEGF-A with high affinity. By neutralising VEGF-A before it can bind to its receptors (VEGFR-1 and VEGFR-2) on endothelial cells, bevacizumab gamma inhibits the signalling cascades that promote angiogenesis (new blood vessel formation), vascular permeability, and endothelial cell proliferation. When injected directly into the vitreous cavity of the eye, bevacizumab gamma reduces CNV activity, decreases retinal fluid accumulation, and can lead to regression of the abnormal blood vessels, resulting in stabilisation or improvement of visual acuity.

Lytenava was evaluated in pivotal phase III clinical trials that compared its efficacy and safety to ranibizumab (Lucentis), one of the most well-established anti-VEGF treatments for wet AMD. The NORSE TWO trial was a randomised, double-masked, active-controlled study that enrolled patients with previously untreated wet AMD. Patients received either intravitreal bevacizumab gamma 1.25 mg or intravitreal ranibizumab 0.5 mg, both administered monthly. The primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline at 11 months.

Results from the NORSE TWO trial demonstrated that Lytenava was non-inferior to ranibizumab in terms of visual acuity improvement, with patients in both treatment groups experiencing clinically meaningful gains in BCVA. Additionally, anatomical outcomes including central subfield thickness (CST) reduction and resolution of intraretinal and subretinal fluid on optical coherence tomography (OCT) were comparable between the two treatment groups. The safety profile of Lytenava was consistent with what is known for intravitreal anti-VEGF therapies, with injection-related adverse events being the most commonly reported.

Lytenava received marketing authorisation from the European Medicines Agency (EMA) in May 2024, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in March 2024. It was launched commercially in the United Kingdom and Germany in June 2025. The approval marked a significant milestone in ophthalmology, providing clinicians with a purpose-manufactured, quality-controlled ophthalmic bevacizumab product that offers a potentially cost-effective alternative to other approved anti-VEGF therapies.

What Should You Know Before Taking Lytenava?

Contraindications

Lytenava must not be used in the following situations:

• Hypersensitivity: Do not use Lytenava if you are allergic (hypersensitive) to bevacizumab gamma, to any other bevacizumab products, to Chinese hamster ovary (CHO) cell-derived products, or to any of the other ingredients listed in the product (trehalose dihydrate, sodium acetate trihydrate, acetic acid glacial, polysorbate 20, and water for injections).
• Active or suspected ocular or periocular infection: Lytenava must not be administered when there is an active infection in or around the eye, as the injection procedure and the immunosuppressive properties of anti-VEGF agents could exacerbate the infection.
• Active severe intraocular inflammation: The presence of active severe inflammation within the eye (such as uveitis) is a contraindication, as intravitreal injection could worsen the inflammatory process.

Warnings and Precautions

Before starting treatment with Lytenava, discuss the following with your healthcare provider:

• Increased intraocular pressure (IOP): Transient increases in IOP have been observed within 60 minutes of intravitreal injection with VEGF inhibitors, including bevacizumab gamma. Sustained IOP increases have also been reported. Your doctor will monitor your IOP and optic nerve head perfusion before and after each injection. Lytenava should not be injected while the IOP is 30 mmHg or above. Patients with poorly controlled glaucoma require careful assessment.
• Thromboembolic events: Although the systemic absorption of bevacizumab after intravitreal injection is very low, there is a theoretical risk of arterial thromboembolic events (such as stroke or heart attack) based on the known pharmacological effects of systemic VEGF inhibition. Patients with a history of stroke, transient ischaemic attack (TIA), myocardial infarction, or other cardiovascular events should be carefully evaluated before treatment, and the risks and benefits should be discussed thoroughly.
• Retinal detachment and retinal pigment epithelial tears: Retinal pigment epithelial (RPE) tears and rhegmatogenous retinal detachment have been reported with intravitreal anti-VEGF therapy. Patients with large pigment epithelial detachments may be at higher risk of RPE tears. Your doctor will assess your retinal anatomy before each injection.
• Bilateral treatment: The safety and efficacy of Lytenava administered in both eyes simultaneously have not been studied. If bilateral treatment is considered, injections should be performed as separate procedures on different days to allow monitoring for post-injection complications in each eye independently.

Pregnancy and Breastfeeding

There are no adequate data on the use of bevacizumab gamma in pregnant women. Based on the pharmacological mechanism of action of VEGF inhibitors and findings from animal studies with systemically administered bevacizumab, treatment with Lytenava may pose a risk to embryo-foetal development, including potential effects on angiogenesis, which is critical for normal foetal development. Although systemic exposure after intravitreal injection is low, Lytenava should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.

Women of childbearing potential should use effective contraception during treatment with Lytenava and for at least 6 months after the last injection. If you become pregnant during treatment, inform your doctor immediately so that the risks and benefits of continued treatment can be reassessed.

It is not known whether bevacizumab gamma is excreted in human breast milk. As human IgG antibodies are known to be present in breast milk, a risk to the breastfed infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Lytenava therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

Driving and Operating Machinery

The intravitreal injection procedure may cause temporary visual disturbances, including blurred vision, that can affect your ability to drive or use machines. Do not drive or operate machinery until any visual disturbances have resolved, which typically takes several hours after the injection. Your treating ophthalmologist will advise you on when it is safe to resume these activities.

How Does Lytenava Interact with Other Drugs?

No formal drug interaction studies have been conducted with intravitreal bevacizumab gamma. Due to the localised route of administration (injection directly into the eye) and the very small dose used (1.25 mg per injection), systemic exposure to bevacizumab gamma is minimal. Peak serum concentrations after intravitreal injection are approximately 400–600-fold lower than those achieved with the oncological intravenous dose of bevacizumab. Consequently, clinically significant systemic pharmacokinetic drug interactions are not anticipated.

However, there are important pharmacodynamic considerations that should be discussed with your doctor:

It is important to inform your ophthalmologist about all medications you are currently taking, including prescription medications, over-the-counter drugs, vitamins, supplements, and herbal products. While systemic drug interactions with intravitreal Lytenava are unlikely, this information helps your doctor provide comprehensive care and monitor for potential risks, particularly relating to bleeding and thromboembolic events.

If you are currently receiving another anti-VEGF treatment for your wet AMD (such as ranibizumab, aflibercept, or faricimab), your doctor will determine the appropriate timing for switching to Lytenava. Typically, the switch is made at the time of the next scheduled injection, effectively replacing one anti-VEGF agent with another without overlap.

What Is the Correct Dosage of Lytenava?

Lytenava is supplied as a 25 mg/mL solution for injection in a single-use glass vial. Each vial contains 0.3 mL of solution, providing a usable amount sufficient to deliver a single dose of 0.05 mL (1.25 mg bevacizumab gamma). The injection must be performed by a qualified ophthalmologist or a healthcare professional experienced in administering intravitreal injections, under controlled aseptic conditions.

Adults

Treatment with Lytenava is initiated with one injection per month. This loading phase continues until maximum visual acuity is achieved and/or there are no signs of disease activity, as determined by clinical examination and optical coherence tomography (OCT) imaging. Once maximum visual acuity has been maintained for three consecutive monthly assessments without signs of disease activity, treatment may be discontinued. However, the patient should continue to be monitored, as wet AMD can recur, and retreatment may be necessary.

If visual acuity and retinal anatomy show deterioration after treatment is paused, treatment should be resumed. Monitoring visits should typically occur at least every one to two months during treatment pauses. The treatment interval should not exceed one month between injections during active treatment.

Children and Adolescents

Lytenava is not indicated for use in children and adolescents under 18 years of age. Wet AMD is an age-related condition that does not occur in paediatric populations. The safety and efficacy of bevacizumab gamma in paediatric patients have not been established.

Elderly Patients

No dose adjustment is required for elderly patients. The majority of patients with wet AMD are elderly (typically over 65 years of age), and the clinical trial population was representative of this demographic. No overall differences in safety or efficacy were observed based on age. However, elderly patients may have an increased baseline risk of cardiovascular events, and this should be considered in the benefit-risk assessment.

Renal and Hepatic Impairment

No dose adjustment is necessary for patients with renal or hepatic impairment. Due to the intravitreal route of administration and the very low systemic exposure, clinically meaningful effects of organ impairment on the pharmacokinetics of bevacizumab gamma are not expected.

Missed Dose

If you miss a scheduled injection of Lytenava, contact your ophthalmologist to reschedule as soon as possible. Do not attempt to administer a double dose. The treatment schedule should be resumed based on your doctor’s guidance, taking into account the disease activity observed at the rescheduled visit. Delays in treatment can allow disease activity to resume, potentially leading to vision loss, so it is important to attend all scheduled appointments.

The Injection Procedure

Lytenava is administered by your ophthalmologist or a trained healthcare professional. The procedure typically follows these steps:

1. Pre-treatment assessment: Your doctor will examine your eye, measure your intraocular pressure, and check for any signs of infection or inflammation. If your IOP is 30 mmHg or above, the injection will be postponed.
2. Anaesthesia: Appropriate local anaesthesia (topical and/or subconjunctival) is administered to numb the eye and surrounding area, minimising discomfort during the injection.
3. Aseptic preparation: A broad-spectrum topical antimicrobial agent (such as povidone-iodine) is applied to the eyelid, periocular skin, and conjunctival surface. A sterile drape and speculum are used to keep the eye open and maintain a sterile field.
4. Injection: A 30-gauge needle is used to inject 0.05 mL (1.25 mg) of Lytenava into the vitreous cavity through the pars plana (approximately 3.5–4 mm posterior to the limbus). The entire injection takes only a few seconds.
5. Post-injection monitoring: Your doctor will monitor your intraocular pressure and check for any immediate complications. You will be observed for a period after the injection before being discharged.
6. Post-injection care: You may be prescribed antibiotic eye drops for several days after the injection. Avoid rubbing your eye, and report any symptoms of endophthalmitis (pain, redness, light sensitivity, decreased vision) immediately.

What Are the Side Effects of Lytenava?

Like all medicines, Lytenava can cause side effects, although not everybody gets them. The majority of adverse reactions reported with Lytenava are related to the intravitreal injection procedure rather than to the active substance itself. These injection-related events are generally mild to moderate in severity and resolve without specific treatment. The safety profile of Lytenava is consistent with the well-established safety profile of intravitreal anti-VEGF therapies that have been used extensively for over 15 years.

Data from the NORSE TWO pivotal clinical trial and post-marketing experience form the basis of the known safety profile. In the clinical trial, the overall rate of adverse events was comparable between the bevacizumab gamma and ranibizumab treatment groups, confirming the well-characterised safety profile of intravitreal anti-VEGF therapy.

Most injection-related side effects such as conjunctival haemorrhage, mild eye pain, and floaters are self-limiting and resolve within days to weeks without treatment. Conjunctival haemorrhage, the most commonly reported side effect (affecting approximately 5% of patients), is a painless condition where a small amount of blood becomes visible on the surface of the eye. It is caused by the needle puncture and resolves spontaneously, typically within 1–2 weeks.

The most serious potential complication of any intravitreal injection is endophthalmitis, an infection inside the eye that can cause severe and potentially permanent vision loss if not treated promptly. The risk of endophthalmitis with intravitreal anti-VEGF injections is estimated at approximately 0.03–0.05% per injection when strict aseptic technique is followed. Signs and symptoms of endophthalmitis include sudden onset of eye pain, increasing redness, blurred or decreased vision, light sensitivity, and hypopyon (a visible collection of pus in the anterior chamber of the eye). If you experience any of these symptoms following your injection, seek immediate medical attention.

How Should You Store Lytenava?

Proper storage of Lytenava is essential to maintain the stability, sterility, and efficacy of the medication. Bevacizumab gamma is a biologic medicine (a monoclonal antibody protein) that is sensitive to temperature extremes, light exposure, and physical agitation, all of which can cause protein degradation, aggregation, or loss of biological activity.

The following storage conditions must be observed:

• Temperature: Store in a refrigerator at 2–8 °C (36–46 °F). Do not freeze the product. If the solution has been frozen, it must not be used and should be discarded.
• Light protection: Keep the vial in the outer carton at all times to protect it from light. Exposure to ultraviolet light can cause degradation of the protein.
• Shelf life: Use the product before the expiry date printed on the vial label and outer carton. Do not use Lytenava after the expiry date.
• Before use: Remove the vial from the refrigerator and allow it to reach room temperature before the injection. Do not heat it using a microwave, warm water, or any other external heat source.
• Visual inspection: Before administration, visually inspect the solution through the vial. The solution should be clear to slightly opalescent, colourless to slightly brownish-yellow, and free from visible particles. Do not use if the solution is cloudy, discoloured, or contains particles.
• Single-use only: Each vial of Lytenava is intended for single use only. Any unused solution remaining in the vial must be discarded. Do not store opened vials for later use.

Keep Lytenava out of the sight and reach of children. Do not dispose of the vial in household waste. Your healthcare provider will dispose of used vials and needles in accordance with local sharps disposal regulations.

What Does Lytenava Contain?

Lytenava is a sterile, preservative-free, clear to slightly opalescent, colourless to slightly brownish-yellow solution supplied in a single-use Type I glass vial sealed with a butyl rubber stopper and an aluminium seal with a flip-off cap.

Bevacizumab gamma is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cell culture. It is a humanized monoclonal antibody of the IgG1 subclass with a molecular weight of approximately 149 kDa. The antibody specifically binds to all biologically active isoforms of human VEGF-A (including VEGF₁₂₁, VEGF₁₆₅, and VEGF₁₈₉) with high affinity.

The product does not contain preservatives. It does not contain latex. Lytenava contains less than 1 mmol (23 mg) of sodium per dose, meaning it is essentially sodium-free. This is relevant for patients who are monitoring their sodium intake for medical reasons.