Our commitment to better solutions
Neovascular (wet) age-related macular degeneration (nAMD) is a leading cause of central visual impairment and blindness in adults 65 years of age or older. Without timely treatment, most patients experience irreversible vision loss. Outlook Therapeutics is committed to advancing ophthalmic therapies designed to address important unmet needs in retinal disease.
The burden of nAMD
nAMD (wet AMD) affects approximately 1.75 million people in the United States, with an additional 7 million at risk of developing the disease. As the population ages, the need for effective treatment options continues to grow.
The need for ophthalmic innovation
Anti-vascular endothelial growth factor (VEGF) therapy has transformed the treatment of nAMD. As ophthalmic therapies continue to evolve, innovation remains essential to advancing treatment options developed specifically for intravitreal use (use inside the eye) while meeting rigorous standards for quality, manufacturing, and regulatory oversight.
The importance of ophthalmic quality
Ophthalmic biologics intended for intravitreal administration (administration into the eye) are developed to meet stringent standards throughout their lifecycle—from formulation and manufacturing to storage and distribution—to help support product quality and consistency.
Formulation
Products developed specifically for ophthalmic use are designed to meet quality standards appropriate for intravitreal administration.
Manufacturing
Controlled manufacturing processes help support product quality, sterility, and consistency.
Storage and distribution
Careful handling throughout storage and distribution helps preserve product integrity until administration.
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
A milestone in ophthalmic innovation
The FDA approval of LYTENAVA™ (bevacizumab-vikg injection) marks an important milestone as the first and only FDA-approved ophthalmic bevacizumab formulation for the treatment of nAMD (wet AMD). Developed specifically for intravitreal use, LYTENAVA reflects our commitment to advancing innovative ophthalmic therapies.
