Setting New Standards in Vision
We Honor the Commitment of the Retina Community
The historical use of repackaged bevacizumab for intravitreal injections emerged as an alternative approach to treating multiple retinal conditions. This showcased the ingenuity and dedication of eye care professionals within the retina community to provide effective treatment for their patients.1
We Adhere to Stringent Ophthalmic Regulations
The goals of ophthalmic regulatory requirements are multifaceted:2
1. Ensure patient safety by minimizing the risk of complications from intravitreal injections
2. Safeguard treatment efficacy by maintaining potency throughout the product’s shelf life
3. Establish quality control measures that extend from manufacturing to distribution to clinical use, ensuring consistent product performance
Regulatory agencies have set more rigorous standards for medications intended for intravitreal use and for biologics. These standards are crucial for ensuring the safety, efficacy and quality of treatment for conditions such as we age-related macular degeneration.2
1. Rosenthal 2005 2. FDA 2015
Important Criteria for Consistent Potency and Safety
Controlled Distribution and Storage
The distribution and storage of these drugs must be strictly controlled to ensure that the product maintains its quality and potency from the manufacturing facility to the site of treatment.1
For ophthalmic drugs, maintaining potency and sterility is particularly crucial, as these products are applied directly to highly sensitive tissues.2 Temperatures and humidity levels outside the recommended range while in transit and during storage can lead to degradation of the active ingredient in biologic drugs such as bevacizumab, reducing their potency.3
Shelf life, determined through rigorous stability testing mandated by regulators, is also a critical factor in maintaining drug quality over time. The limited shelf life of repackaged bevacizumab leaves little room for error or delay in the distribution process, further adding to the challenges with frequent recalls and shortages.4
Appropriate pH
The stability of biologic drugs is highly dependent on pH of the solution.5
Lower Limits on Particulate Matter
The presence of particulates in ophthalmic drugs can lead to sterility issues and immune reaction.6
Sterility
Sterility is crucial for ophthalmic products, as the eye is particularly vulnerable to infection.7
1. WHO 2020 2. QSC 1995 3. Aldrich, Dale S., Bach, Cynthia M., Brown, William, Chambers, Wiley, Fleitman, Jeffrey, Hunt, Desmond, Marques, Margareth R. C., Mille, Yana, Mitra, Ashim K., Platzer, Stacey M., Tice, Tom, Tin, George W.; Ophthalmic Preparations USP STIMULI TO THE REVISION PROCESS Vol. 39(5) [Sept.–Oct. 2013]; Missel PJ, Lang JC, Rodeheaver DP, Jani R, Chowhan MA, Chastain J, Dagnon T. Design and evaluation of ophthalmic pharmaceutical products. In: Florence, AT, Siepmann J. Modern Pharmaceutics—Applications and Advances. New York: Informa; 2009:101–189. Abbreviations: EMA – European Medicines Agency; EU – European Union; FDA – Food and Drug Administration; GMP – Good Manufacturing Practice; IV – intravenous; pH – potential of hydrogen; Ph. Eur. – European Pharmacopoeia ; USP – United States Pharmacopeia 4. Chen 2009; Liu 2011 5. Ph. Eur. 0520 6. Yanuzzi 2015 7. Ph. Eur. 2.6.1
About Bevacizumab
Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally (National Eye Institute).
We Embrace and Enforce the Highest Standards
Until now, a formulation of bevacizumab that meets more stringent ophthalmic standards has not been available for routine use in eye care. This is because no regulatory body in the world had previously approved bevacizumab specifically for intravitreal injection. Today, we stand at the threshold of a new era.
Developing an approved ophthalmic version of bevacizumab honors the history of its use in the retina community by elevating the standard of care to meet rigorous regulatory requirements.
Our approach respects the pioneering spirit of the retina community while embracing the highest standards of modern pharmaceutical development and regulation. This represents a significant step forward in eye care, combining the legacy of bevacizumab with the assurance of a product that meets all ophthalmic standards – every dose, every time.
About Bevacizumab
Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally (National Eye Institute).
