May 17, 2020

EU Approves Alcon’s Simbrinza to Treat Patients with Glaucoma, Ocular Hypertension

Novartis
Patient Care
Europe Healthcare
Alcon
Admin
2 min
Elevated IOP is the only known modifiable risk factor for glaucoma and can typically be controlled with daily administration of eye drops, several times a day.
Alcon, the global leader in eye care and a division of Novartis, has announced that their Simbrinza® eye drops have been approved by the European Co...

Alcon, the global leader in eye care and a division of Novartis, has announced that their Simbrinza® eye drops have been approved by the European Commission (EU) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension.

Simbrinza combines brinzolamide and brimonidine, two well-established treatments for elevated IOP, and is the only fixed-combination glaucoma treatment without a beta-blocker.

“Simbrinza complements Alcon’s glaucoma portfolio by addressing a significant unmet patient need. We are pleased to introduce the only fixed-combination therapy without a beta-blocker to help more glaucoma patients manage their progressive eye condition,” said Jeff George, global head of Alcon, in a news release.

“As the leader in eye care, Alcon will continue to invest in R&D to expand our broad portfolio of glaucoma treatment options and to further reduce the burden of this silent, sight-threatening disease.” 

Glaucoma is the second cause of blindness after cataract and affects more than 60 million people worldwide, according to the European Glaucoma Society. Less than 50 percent of those with glaucoma are even aware of their disease prior to blindness.

Elevated IOP is the only known modifiable risk factor for glaucoma and can typically be controlled with daily administration of eye drops, several times a day. In severe cases, surgery is the only option.

“Based on the literature, up to 80 percent of patients deviate from their treatment regimen, resulting in poor adherence and the increased risk of progressive vision loss,” said Barbara Cvenkel, MD, Head of Glaucoma Unit, Eye Hospital Ljubljana, Slovenia and member of the Executive Committee of the European Glaucoma Society (EGS). “When appropriate, the EGS recommends the use of combination therapies, such as Simbrinza, which provides a less complicated administration routine by decreasing the number of eye drops to handle and reducing the treatment burden for patients affected by this eye disease.”

Two six-month studies were conducted by Alcon to evaluate the safety and efficacy of Simbrinza administered twice daily. A total of 1,450 patients with open-angle glaucoma or ocular hypertension were enrolled. Results of the studies are expected to be presented at the 32nd Congress of the European Society of Cataract and Refractive Surgeons in London, United Kingdom, on September 13-14, 2014, and during the Glaucoma Day Programme on September 12, 2014.

The launch of Simbrinza in the EU will begin in the UK in the third quarter of 2014, followed by other European markets in 2014 and 2015. In the US, Simbrinza was approved by the US Food and Drug Administration (FDA) and has been available in the market since 2013. 

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Apr 30, 2021

The challenges to vaccine distribution affecting everyone

covid-19vaccine
vaccinesupply
Supplychain
Blockchain
Jonathan Colehower
5 min
The challenges to vaccine distribution affecting everyone
Jonathan Colehower, CEO at CargoChain, describes the COVID-19 vaccine distribution challenges impacting every country, organisation and individual...

While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined. 

Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.  

Production capacity 

Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short. 

Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification. 

The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.

It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.

Distribution requirements

It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.

For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.  

The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.

Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.

Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.

Disconnected information systems 

While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration. 

A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.

By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.

Political influence and social equality 

As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.

In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.  

However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.

Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution. 

The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.

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