Preservative-free multidose dispenser approved across Europe for glaucoma treatment
Aptar Pharma working closely with Santen Pharmaceutical to improve patient safety, achieve dosing accuracy and maintain product integrity.
Aptar Pharma's innovative, preservative-free multidose Ophthalmic Squeeze Dispenser has been approved for Santen’s prescription drug Taflotan/Saflutan for the reduction of elevated intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension in 26 countries in Europe.
This approval reconfirms the market-leading position of Aptar Pharma’s Ophthalmic Squeeze Dispenser as an approved delivery system for eye disease treatment formulations without any preservatives.
Meeting the needs of patients
Aptar Pharma is working closely with leading global ophthalmology specialist Santen Pharmaceutical to improve patient safety, achieve dosing accuracy and maintain product integrity. Santen is a specialized global pharmaceutical company dedicated to the ophthalmology field, and is spearheading the development and marketing of preservative-free drugs as part of its mission to contribute to the well-being of patients, their loved ones and society.
"We are delighted to launch preservative-free multidose formulations of these glaucoma therapies in Europe,” said Luis Iglesias, Corporate Officer and Head of EMEA, Santen. “By providing highly effective and well-tolerated, preservative-free medicines, with the option for multi-dose bottles, we hope to empower patients in their daily lives and improve the management of their condition.”
Chemical preservatives are often used in eye drops to ensure sterility of the drops in multidose bottles. When used in short-term treatments, they are mostly well-tolerated. For long-term use, such as in chronic conditions that include dry eye and glaucoma, preservative-free products are preferred. Preservatives have been known to cause signs and symptoms of irritation, allergy and ocular surface toxicity. Glaucoma patients use eye drops on a regular basis, and often for the rest of their lives.
Approval
BfArM, the German Regulatory Agency, approved Santen’s prescription drug Taflotan/Saflutan in the preservative-free multidose Ophthalmic Squeeze Dispenser in Germany as a first country in February 2017. Prior to this approval, Santen provided comprehensive and detailed microbiological study results as requested by BfArM. These showed that micro-organisms can neither survive nor form colonies in or on the container. The European registration process for several additional European countries ended positively and consequently, national marketing authorizations have been granted based on the European harmonized evaluation.
In addition, Santen performed usability studies that confirmed the user-friendliness of the multidose dispenser with glaucoma patients.
Making ophthalmic solutions easier and safer to deliver
Aptar Pharma’s Ophthalmic Squeeze Dispenser system is the result of more than 10 years of development and experience in the delivery of preservative-free ophthalmic solutions. Patients and consumers in the US, Europe, Latin America and Asia have benefited from this technology since 2012, with more than 175 commercial references now available on the market.
“Our Ophthalmic Dispenser technology has been a great success for our customers,” explained Matthias Birkhoff, VP Business Development, Aptar Pharma. “The proven and unrivalled microbiological safety, combined with a precise and reproducible drop ejection, allows pharmaceutical customers worldwide to enter into discussions with regulatory agencies such as the German BfArM with confidence.” Mr. Birkhoff also points out the user-friendliness of the system, adding “The ergonomic, pocket-size design and the intuitiveness of a squeezable container with a low actuation force certainly contribute to the high levels of acceptance among patients and consumers worldwide.”
Staying ahead of the market
Aptar Pharma's Ophthalmic Squeeze Dispenser provides a unique competitive advantage by addressing the worldwide trend towards patient-friendly, cost-effective and preservative-free multidose dispensers.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance