TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

BYOOVIZ

RANIBIZUMAB-NUNA Vascular Endothelial Growth Factor Inhibitors
Ophthalmology Approved 2021-09-17

BYOOVIZ (ranibizumab-nuna) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several retinal conditions. It is used in patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The drug serves a therapeutic role by addressing the underlying pathophysiology of vision loss associated with abnormal blood vessel growth and leakage in the eye.

Source: FDA Label • SAMSUNG BIOEPIS CO LTD • Vascular Endothelial Growth Factor Inhibitor

How BYOOVIZ Works

Ranibizumab-nuna functions by binding to the receptor binding site of active forms of vascular endothelial growth factor A (VEGF-A). By binding to this protein, the drug prevents VEGF-A from interacting with its receptors, VEGFR1 and VEGFR2, on the surface of endothelial cells. This inhibition reduces the proliferation of endothelial cells, decreases vascular leakage, and limits the formation of new blood vessels. These actions target the biological processes that contribute to neovascularization and edema in the retina.

Source: FDA Label
2
Indications
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2021-09-17
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: RANIBIZUMAB-NUNA

BYOOVIZ Approval History

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What BYOOVIZ Treats

4 indications

BYOOVIZ is approved for 4 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Neovascular Age-Related Macular Degeneration
  • Macular Edema
  • Retinal Vein Occlusion
  • Myopic Choroidal Neovascularization
Source: FDA Label

BYOOVIZ Target & Pathway

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Target

VEGF (Vascular Endothelial Growth Factor) Growth Factor

A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.

Pathway Context

VEGF binds to VEGFR on blood vessel cells to stimulate new vessel formation

VEGFR (Vascular Endothelial Growth Factor Receptor) receptor

Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.

Auto-substitute OK for Lucentis

Pharmacists can substitute BYOOVIZ for Lucentis without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.

BYOOVIZ Competitors

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6 other drugs also target VEGF. Compare mechanisms, indications, and trial activity.

Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (VEGF). Earlier expiry dates signal biosimilar/generic opportunities.

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BYOOVIZ FDA Label Details

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Indications & Usage

FDA Label (PDF)

BYOOVIZ is indicated for the treatment of patients with: BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Myopic Choroidal Neovascularization (mCNV)

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.