There’s so
much more to see

Look closer and you will see the impact BYOOVIZ, a biosimilar* to Lucentis® (ranibizumab injection), may have on the lives of more patients

BYOOVIZ injection for intravitreal use is an FDA-approved, interchangeable† biosimilar indicated to treat nAMD, macular edema following RVO, and mCNV1-3

FDA=US Food and Drug Administration; mCNV=myopic choroidal neovascularization; nAMD=neovascular age-related macular degeneration; RVO=retinal vein occlusion.

*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.1

†An interchangeable biosimilar is a biosimilar that may be substituted without consulting the prescribing health care professional. This practice is called “pharmacy-level substitution” and is subject to state law.2,3

Indication and Important
Safety Information
INDICATIONS
BYOOVIZ® (ranibizumab-nuna), 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)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
  • BYOOVIZ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in BYOOVIZ
  • Hypersensitivity reactions may manifest as severe intraocular inflammation
WARNINGS AND PRECAUTIONS Endophthalmitis and Retinal Detachments
  • Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis, retinal detachments, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be used when administering BYOOVIZ. In addition, patients should be monitored following the injection to permit early treatment, should an infection occur
Increases in Intraocular Pressure
  • Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with BYOOVIZ and manage appropriately
Thromboembolic Events
  • Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)
  • Neovascular (Wet) Age-Related Macular Degeneration

    • The ATE rate in the three controlled neovascular AMD studies (AMD-1, AMD-2, AMD-3) during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of ranibizumab-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3

      In a pooled analysis of 2-year controlled studies [AMD-1, AMD-2, and a study of ranibizumab used adjunctively with verteporfin photodynamic therapy (PDT)], the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg of ranibizumab compared to 1.1% (5 of 435) in patients in the control arms [odds ratio 2.2 (95% confidence interval; 0.8-7.1)]

  • Macular Edema Following Retinal Vein Occlusion
    • The ATE rate in the two controlled RVO studies during the first 6 months was 0.8% in both the ranibizumab and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of ranibizumab-treated patients compared to 0.4% (1 of 260) in the control arms
Retinal Vasculitis With or Without Occlusion
  • Retinal vasculitis with or without occlusion, typically in the presence of preexisting intraocular inflammation or post-treatment with other intravitreal agents, have been reported with the use of ranibizumab products. Discontinue treatment with BYOOVIZ in patients who develop these events. Patients should be instructed to report any change in vision without delay

ADVERSE REACTIONS

  • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular adverse reactions included nasopharyngitis, anemia, nausea, and cough
  • As with all therapeutic proteins, there is potential for immunogenicity. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

You are encouraged to report suspected adverse reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.

References

  1. BYOOVIZ Prescribing Information, Harrow IP, LLC.
  2. US Food and Drug Administration. Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products. https://www.fda.gov/drugs/ourperspective/​updated-fda-labeling-recommendations-biosimilar-and-interchangeable-biosimilar-products. Accessed January 13, 2025.
  3. US Food and Drug Administration. Purple Book Database of Licensed Biological Products. https://purplebooksearch.fda.gov/​results?query=ranibizumab&title=Byooviz. Accessed January 13, 2025.