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  2. Santen launches preservative-free multi-dose Cosopt® and Taflotan®/Saflutan®, providing personalised management for glaucoma patients in Europe

Santen launches preservative-free multi-dose Cosopt® and Taflotan®/Saflutan®, providing personalised management for glaucoma patients in Europe

Mon 25 February 2019

Today Santen announces that the preservative-free, formulation Cosopt iMulti® (20mg/ml dorzolamide + 5mg/ml timolol eye drops, solution) and the preservative-free multi-dose formulation of Taflotan®/Saflutan® (15 μg/ml tafluprost eye drops, solution) will launch in Europe in the coming months. The granting of licences by the relevant national European competent authorities represents an innovation in glaucoma management, providing preservative-free medicines in multi-dose bottles to allow for effective and convenient, 24-hour intraocular pressure (IOP) control to glaucoma patients aged 18 or over.1, 2

Preservatives can cause and exacerbate pre-existing ocular surface disease (OSD), an umbrella term that includes dry eye, lid disease and conjunctivitis.3 The condition can result in damage to ocular surface epithelial cells and cause patients significant discomfort and dissatisfaction.3 These adverse effects can lead to patient-led discontinuation of treatment, particularly in chronic, asymptomatic conditions such as glaucoma.

“Preservative-induced adverse events are sometimes difficult to identify. However, mild symptoms should not be underestimated as they may very well be manifestations of more severe, threatening inflammatory reactions that can later cause major concerns,” commented Professor Christophe Baudouin, MD, PhD, FARVO, Quinze-Vingts National Ophthalmology Hospital, Vision Institute, Sorbonne University Paris, France. “The launch of these preservative-free multi-dose glaucoma medications will have a positive clinical impact, particularly in patients who already have damage to the ocular surface, such as in dry eye disease or allergic eyes.” 

The European Medicines Agency (EMA) outlines that preservatives should be avoided in patients who are on long-term treatment, or do not tolerate preserved eye drops.4 Switching from preserved to preservative-free topical ocular medications can diminish the harmful effects caused by preservatives.3 For example, switching to Cosopt® preservative-free improved local ocular tolerability for 85% of patients compared with their previous preserved medication.5 The medicines’ efficacy and safety profiles are consistent with their formulations, for example Taflotan®/Saflutan® has been shown to effective in offering 24 hour IOP control as well as well tolerated and easy for patients to use, with a low incidence of adverse events, such as hyperaemia (4%).2 

Provision of these medicines in both single and multi-dose formulations provides patients with a convenient and flexible way to manage their condition.6,7 The preservative-free multi-dose bottles for Taflotan®/Saflutan® are designed by Aptar Pharma with patients in mind, with proven microbiological safety, combined with a precise and reproducible drop ejection.8

“The ergonomic, pocket-size design and the intuitive, squeezable container with a low actuation force certainly contribute to the high levels of acceptance among patients and consumers worldwide,” explained Matthias Birkhoff, VP Business Development, Aptar Pharma. “We are delighted that these medicines have been granted licences in Europe.”

Those for Cosopt®, developed by Nemera, feature a low squeeze force and smooth bottle, to reduce the pressure required to dispense a drop and improve ease-of-use, particularly for the elderly.6,7

“Patient adherence is the key for success for all treatments, especially silent chronic ophthalmic diseases. This is why, at Nemera, we developed an innovative system combining all patient needs: a safe preservative-free multi-dose bottle with a blue tip that makes consistent drops one by one” commented Fanny Sellier, Global Category Manager for Ophthalmic Products, Nemera.

Taflotan®/Saflutan® is indicated for the reduction of elevated IOP in open angle glaucoma and ocular hypertension who would benefit from preservative-free eye drops.2 Cosopt® is indicated in the treatment of elevated IOP in patients with open-angle glaucoma or pseudoexfoliative glaucoma when topical beta-blocker monotherapy is not sufficient.1 European local market launches of the new preservative-free multi-dose formulations are expected throughout 2019.

"We are delighted to launch preservative-free multi-dose 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.”

References: 

  1. Cosopt SmPC, available here: https://www.medicines.org.uk/emc/product/5114/smpc  
  2. Taflotan/Saflutan SmPC, available here: https://www.medicines.org.uk/emc/product/5115/smpc  
  3. Steven, DW et al. Preservative in glaucoma medication. British Journal of Ophthalmology 2018;102:1497-1503 
  4. EMA Public Statement. Doc. Ref.: EMEA/622721/2009. Last accessed: December 2018 
  5. Renieri G et al. Efficacy and tolerability of preservative-free eye drops containing a fixed combination of dorzolamide and timolol in glaucoma patients. Journal of Ocular Pharmacology and Therapeutics 2010;26 (6):597–603. 
  6. Kaarniranta K et al. Preferences and ease of use of preservative-free IOP-lowering eye drop containers: A comparison of two multi-dose bottles. Clinical Investigation 2018; DOI:10.4172. 
  7. Novelia White Paper. Accessible at: http://www.nemera.net/wp-content/uploads/2014/06/WP-Novelia-alternativetofilters-June2015.pdf Last accessed: December 2018 
  8. Aptar Pharma White Paper: Accessible at: https://pharma.aptar.com/sites/default/files/publications/aptar_pharma_osd_oct_2017_ddd.pdf