Beovu: Uses, Dosage & Side Effects

What Is Beovu and What Is It Used For?

Beovu contains the active substance brolucizumab, a humanized single-chain antibody fragment (scFv) that belongs to a group of medicines called antineovascular agents. These medications work by targeting and neutralizing vascular endothelial growth factor A (VEGF-A), a signaling protein that plays a central role in the formation of new blood vessels (angiogenesis) and in increasing vascular permeability (the leakiness of blood vessels). In the context of retinal disease, excess VEGF-A drives the pathological processes that lead to vision loss.

Beovu is administered by a qualified ophthalmologist as an intravitreal injection, meaning it is injected directly into the vitreous humor, the gel-like substance that fills the interior of the eye. Each injection delivers 6 mg of brolucizumab in a volume of just 0.05 ml. The remarkably small molecular size of brolucizumab (approximately 26 kilodaltons, compared to approximately 48 kDa for ranibizumab and approximately 115 kDa for aflibercept) allows a much higher molar dose to be delivered within the same small injection volume. This higher molar concentration is believed to contribute to the drug's potent and durable suppression of VEGF activity within the eye.

Brolucizumab works by binding to all three major isoforms of VEGF-A (VEGF110, VEGF121, and VEGF165), preventing them from interacting with their receptors, VEGFR-1 and VEGFR-2, on the surface of endothelial cells. By blocking this VEGF-receptor interaction, brolucizumab inhibits the proliferation and migration of endothelial cells, suppresses the growth of new, abnormal blood vessels (neovascularization), and reduces the permeability of existing vessels. This translates into reduced fluid accumulation (edema) in the macula and slowed progression of the underlying disease.

Wet Age-Related Macular Degeneration (Wet AMD)

Age-related macular degeneration (AMD) is one of the leading causes of severe vision loss in people over the age of 50 worldwide. The neovascular, or "wet," form of AMD accounts for approximately 10-15% of all AMD cases but is responsible for the majority of severe vision loss associated with the disease. In wet AMD, abnormal blood vessels grow from the choroid (the vascular layer beneath the retina) through Bruch's membrane into the sub-retinal or sub-retinal pigment epithelium (RPE) space. These abnormal vessels, known as choroidal neovascularization (CNV), are fragile and prone to leaking fluid, lipids, and blood into the surrounding retinal tissue.

This leakage causes swelling (edema) of the macula, the central part of the retina responsible for sharp, detailed vision needed for activities such as reading, driving, and recognizing faces. If untreated, the ongoing fluid accumulation and hemorrhage can lead to scarring and irreversible destruction of photoreceptor cells, resulting in permanent central vision loss. Beovu, by potently inhibiting VEGF-A, aims to reduce or eliminate this pathological vascular leakage, halt the growth of new abnormal vessels, and thereby preserve or restore macular function.

The clinical efficacy of Beovu in wet AMD was established in the pivotal HAWK and HARRIER phase III clinical trials. These large, multicenter, randomized studies compared brolucizumab 6 mg (and 3 mg in HAWK) with aflibercept 2 mg in over 1,800 treatment-naive patients with wet AMD. Both trials demonstrated that brolucizumab was non-inferior to aflibercept in terms of best-corrected visual acuity (BCVA) change from baseline at week 48. Importantly, a significantly greater proportion of patients treated with brolucizumab were maintained on a 12-week (every 3 months) treatment interval compared with the every-8-week interval used with aflibercept. Additionally, brolucizumab-treated patients showed superior anatomical outcomes, including greater reductions in central subfield thickness (CST) and retinal fluid.

Diabetic Macular Edema (DME)

Diabetic macular edema (DME) is a common and sight-threatening complication of diabetes mellitus. It occurs when chronic hyperglycemia (high blood sugar) damages the blood vessels in the retina, leading to increased vascular permeability and the accumulation of fluid within the macula. DME is the leading cause of vision loss in working-age adults with diabetes and can significantly impair quality of life and functional independence.

The pathogenesis of DME involves a complex interplay of factors, including upregulation of VEGF-A, inflammatory mediators, and breakdown of the blood-retinal barrier. Anti-VEGF therapy has become the standard of care for center-involving DME. By blocking VEGF-A, Beovu reduces vascular permeability and macular edema, helping to preserve and improve visual function in patients with DME.

The clinical efficacy of Beovu in DME was demonstrated in the KESTREL and KITE phase III clinical trials. These studies compared brolucizumab 6 mg (and 3 mg in KESTREL) with aflibercept 2 mg in patients with DME. Both trials met their primary endpoint, demonstrating non-inferiority of brolucizumab to aflibercept in BCVA change from baseline at year 1. Similar to the AMD trials, brolucizumab demonstrated strong anatomical outcomes, including significant reductions in central subfield thickness.

What Should You Know Before Receiving Beovu?

Contraindications

There are specific situations in which Beovu must not be used. Understanding these absolute contraindications is essential for patient safety and should be discussed with your ophthalmologist before treatment begins.

• Hypersensitivity: Do not receive Beovu if you are allergic (hypersensitive) to brolucizumab or any of the other ingredients in the product, including sodium citrate, sucrose, polysorbate 80, sodium hydroxide, or water for injections.
• Active or suspected ocular or periocular infection: If you have an infection in or around the eye, treatment must be postponed until the infection has completely resolved. Intravitreal injections carry an inherent risk of introducing bacteria into the eye, and an existing infection could be worsened or spread.
• Active intraocular inflammation: If you are currently experiencing pain, redness, or inflammation inside the eye, Beovu should not be administered. The injection could exacerbate the inflammatory process and potentially lead to further complications.

Warnings and Precautions

Before and during treatment with Beovu, your ophthalmologist will carefully evaluate whether you are a suitable candidate. It is essential to inform your doctor if any of the following conditions or situations apply to you:

• Glaucoma: If you have glaucoma (a condition often caused by elevated pressure inside the eye), inform your doctor. Intravitreal injections can temporarily raise intraocular pressure (IOP), and your ophthalmologist will monitor your eye pressure after each injection.
• Floaters or flashes of light: If you have previously noticed floaters (dark spots or specks drifting in your field of vision) or flashes of light, and particularly if these have suddenly increased in number or size, tell your ophthalmologist. These symptoms may indicate vitreous detachment or retinal tear, which require prompt evaluation.
• Recent or planned eye surgery: If you have had eye surgery within the past 4 weeks or are scheduled for eye surgery within the next 4 weeks, your treatment with Beovu may need to be postponed.
• History of eye diseases or treatments: Any previous eye conditions or treatments should be disclosed to your ophthalmologist, as they may influence the decision to use Beovu or affect the monitoring schedule.
• History of retinal vascular occlusion or retinal vasculitis: If you have experienced sudden vision loss due to blockage of blood vessels in the back of the eye (retinal vascular occlusion) or inflammation of retinal blood vessels (retinal vasculitis) within the past year, Beovu may not be suitable for you. These conditions are recognized risk factors for similar events with Beovu treatment.
• Retinal detachment risk: Your ophthalmologist will assess whether you have risk factors for detachment or tearing of the retinal layers (retinal pigment epithelium or retina itself). In patients with such risk factors, Beovu must be used with particular caution.
• Bilateral treatment: The safety and efficacy of Beovu when administered to both eyes simultaneously have not been studied. Using the drug in both eyes at the same session may increase the risk of side effects.

After each injection, your ophthalmologist will monitor your intraocular pressure, as transient increases can occur within 30 minutes of the injection. Regular follow-up examinations are essential to assess treatment response and detect any complications early.

Pregnancy and Breastfeeding

Beovu should not be used during pregnancy unless the expected clinical benefit to the mother clearly outweighs the potential risk to the unborn child. As a VEGF inhibitor, brolucizumab has the potential to interfere with normal embryonic and fetal development, particularly vascular development. Women of childbearing potential are strongly advised to use effective contraception during Beovu treatment and for at least one month after the last injection.

If you become pregnant or suspect you may be pregnant during treatment, inform your ophthalmologist immediately. The decision to continue or discontinue treatment will be made on an individual basis, weighing the potential benefits against the risks.

Breastfeeding is not recommended during treatment with Beovu and for at least one month after the last dose. It is currently unknown whether brolucizumab or its metabolites are excreted in human breast milk, and a risk to the nursing infant cannot be excluded.

Children and Adolescents

Beovu is not indicated for use in children and adolescents under 18 years of age. The conditions treated by Beovu (wet AMD and DME) predominantly affect adults, and no clinical data are available for pediatric populations.

Driving and Operating Machinery

After receiving a Beovu injection, you may experience temporary visual disturbances such as blurred vision. Do not drive or operate machinery for as long as these visual symptoms persist. Most patients find that their vision returns to baseline within a few hours of the injection, but individual responses may vary.

How Does Beovu Interact with Other Drugs?

Beovu (brolucizumab) is administered by intravitreal injection, meaning it is delivered directly into the eye rather than taken systemically. The amount of brolucizumab that reaches the general circulation after intravitreal injection is minimal. As a result, significant pharmacokinetic interactions with systemically administered drugs are considered unlikely. Nevertheless, it is important to communicate all current medications to your ophthalmologist to ensure the safest possible treatment.

No formal drug-drug interaction studies have been performed with brolucizumab. The clinical trials that established the safety and efficacy of Beovu did not identify any clinically significant drug interactions. However, several theoretical considerations are relevant:

Polysorbate Content

Beovu contains polysorbate 80 (0.01 mg per dose). Polysorbates may cause allergic reactions in sensitive individuals. If you have any known allergies to polysorbates, inform your ophthalmologist before treatment. The formulation also contains less than 1 mmol (23 mg) sodium per dose, meaning it is essentially sodium-free.

What Is the Correct Dosage of Beovu?

Beovu must only be administered by a qualified ophthalmologist with experience in intravitreal injections. Each injection delivers a fixed dose of 6 mg brolucizumab, contained in 0.05 ml of a 120 mg/ml solution. The vial contains more solution than is needed for a single dose (0.23 ml), and the excess must be expelled before injection. Injecting the entire vial contents could result in overdose.

Wet AMD Dosage

DME Dosage

How Beovu Is Administered

The intravitreal injection procedure is performed under sterile conditions in a clinic or hospital setting. Before the injection, your ophthalmologist will thoroughly cleanse the eye and surrounding skin using an antiseptic solution. You will receive local anesthetic eye drops to numb the eye and minimize discomfort during the injection. A sterile lid speculum is used to keep the eye open during the procedure.

The injection is given through the sclera (the white of the eye) into the vitreous cavity using a very fine needle (30-gauge). The entire procedure typically takes only a few minutes. After the injection, your ophthalmologist will monitor your intraocular pressure, as transient increases can occur within 30 minutes. You will be observed for a short period to ensure no immediate complications arise.

Duration of Treatment

Beovu is used to treat chronic eye conditions that typically require long-term management over months or years. Your ophthalmologist will regularly assess whether the treatment is working effectively. It is important to attend all scheduled appointments, even if your vision feels stable, as your doctor may need to evaluate the health of your retina between injections.

Do not stop treatment without consulting your ophthalmologist. Discontinuing anti-VEGF therapy prematurely can lead to recurrence of disease activity, renewed fluid accumulation, and worsening of vision. If you are considering stopping treatment, discuss the risks and potential alternatives with your doctor.

Missed Dose

If you miss a scheduled appointment for a Beovu injection, contact your ophthalmologist's office as soon as possible to reschedule. Delayed treatment may allow disease activity to resume, potentially resulting in vision deterioration. Your ophthalmologist will evaluate your retina and determine the appropriate course of action.

Overdose

Overdose is unlikely in clinical practice because Beovu is administered by a healthcare professional in a controlled setting. The vial contains more solution than the recommended dose to allow proper preparation; the excess must be expelled before injection. If more than the recommended 0.05 ml is inadvertently injected, an excessive rise in intraocular pressure could occur. Your ophthalmologist will monitor your eye pressure and can intervene if necessary, for example by performing paracentesis (removal of a small amount of fluid from the eye) to relieve the pressure.

What Are the Side Effects of Beovu?

The side effects of Beovu may result from the medication itself or from the intravitreal injection procedure. Most side effects primarily affect the treated eye. Many of the common side effects are mild to moderate in severity and typically resolve within one week of each injection. However, some side effects can be serious and require immediate medical attention.

It is important to note that the risk of intraocular inflammation, retinal vasculitis, and retinal vascular occlusion has received particular attention in post-marketing surveillance. These events, while uncommon, can lead to severe and potentially irreversible vision loss. Your ophthalmologist will carefully weigh the benefits and risks of Beovu treatment and will monitor you closely for any signs of these complications.

The injection procedure itself carries a small risk of endophthalmitis (a serious infection inside the eye), which is why the procedure must be performed under strictly sterile conditions. Signs of endophthalmitis include increasing eye pain, worsening redness, blurred or decreased vision, and sensitivity to light, typically developing within a few days of the injection. If you suspect endophthalmitis, seek emergency ophthalmological care immediately.

If any side effects become bothersome or if you experience any effects not listed here, inform your ophthalmologist. Reporting suspected side effects after the medicine has been authorized is an important way of continuously monitoring the benefit-risk balance of the medication. Healthcare professionals and patients are encouraged to report adverse events to their national regulatory authority.

How Should You Store Beovu?

Beovu is a prescription medication that is stored and handled by healthcare professionals in the clinical setting. However, understanding proper storage conditions is important for patients to ensure they receive a product of the highest quality at each treatment visit.

• Refrigeration: Store Beovu in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze the product. If the solution has been frozen, it must not be used.
• Light protection: Keep the vial in the original outer carton to protect it from light. Brolucizumab is sensitive to light, and prolonged exposure could degrade the protein.
• Room temperature: Before use, the unopened vial may be stored at room temperature (below 25°C / 77°F) for up to 24 hours. Once removed from the refrigerator and brought to room temperature, it should be used within this timeframe.
• Expiry date: Do not use Beovu after the expiry date printed on the carton and vial label (EXP). The expiry date refers to the last day of the stated month.
• Keep out of reach: As with all medications, store Beovu out of the sight and reach of children.
• Inspection before use: Before administration, the solution should be visually inspected. Beovu is a clear to slightly opalescent, colorless to slightly brownish-yellow solution. If particles or cloudiness are visible, the vial must not be used.

The vial and blunt filter needle included in the packaging are sterile and intended for single use only. Do not use the product if the packaging, vial, or filter needle appear damaged or if the expiry date has passed. Unused medicine and waste should be disposed of in accordance with local guidelines.

What Does Beovu Contain?

Active Ingredient

The active substance in Beovu is brolucizumab, a humanized single-chain antibody fragment (scFv) directed against vascular endothelial growth factor A (VEGF-A). Each milliliter of solution contains 120 mg of brolucizumab. Each vial contains 27.6 mg of brolucizumab in a total volume of 0.23 ml. This yields a usable amount sufficient to administer a single dose of 0.05 ml, containing 6 mg of brolucizumab.

Inactive Ingredients (Excipients)

• Sodium citrate: Acts as a buffering agent to maintain the pH of the solution, ensuring protein stability.
• Sucrose: A sugar used as a stabilizing agent (cryoprotectant and lyoprotectant) to maintain the structural integrity of the brolucizumab protein.
• Polysorbate 80: A surfactant used at a very low concentration (0.01 mg per dose) to prevent protein aggregation and adsorption to container surfaces. Polysorbates can rarely cause allergic reactions in sensitive individuals.
• Sodium hydroxide: Used for pH adjustment during manufacturing to ensure the solution is at the optimal pH for stability and injection.
• Water for injections: The solvent used to prepare the injectable solution.

The resulting solution is clear to slightly opalescent, colorless to slightly brownish-yellow. Each package contains one glass vial and one blunt filter needle (18G × 1½ inch, 1.2 mm × 40 mm, 5 µm), both intended for single use only. The injection syringe and injection needle are not included in the package and must be supplied separately.

References

This article is based on the following peer-reviewed sources and authoritative guidelines. All medical claims are supported by Level 1A evidence where available.

1. European Medicines Agency (EMA). Beovu (brolucizumab) – Summary of Product Characteristics. Last updated 2025. Available at: ema.europa.eu/en/medicines/human/EPAR/beovu
2. U.S. Food and Drug Administration (FDA). Beovu (brolucizumab-dbll) – Prescribing Information. Revised 2024. Available at: accessdata.fda.gov
3. Dugel PU, Koh A, Ogura Y, et al. HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2020;127(1):72-84. doi:10.1016/j.ophtha.2019.04.017
4. Brown DM, Emanuelli A, Bandello F, et al. KESTREL and KITE: 52-Week Results From Two Phase III Pivotal Trials of Brolucizumab for Diabetic Macular Edema. Am J Ophthalmol. 2022;238:157-172. doi:10.1016/j.ajo.2022.01.004
5. American Academy of Ophthalmology (AAO). Preferred Practice Pattern: Age-Related Macular Degeneration. 2024. Available at: aao.org
6. Schmidt-Erfurth U, Chong V, Loewenstein A, et al. Guidelines for the Management of Neovascular Age-Related Macular Degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014;98(9):1144-1167. Updated 2023.
7. Baumal CR, Spaide RF, Vajzovic L, et al. Retinal Vasculitis and Intraocular Inflammation after Intravitreal Injection of Brolucizumab. Ophthalmology. 2020;127(10):1345-1359. doi:10.1016/j.ophtha.2020.04.017
8. World Health Organization (WHO). World Report on Vision. 2019. Available at: who.int

Editorial Team

This article has been written, reviewed, and fact-checked by the iMedic Medical Editorial Team, a multidisciplinary team of licensed specialist physicians with expertise in ophthalmology, retinal disease, and clinical pharmacology.