Allergan, Inc have announced that the European Medicines Agency have extended the marketing authorisation of GANFORT® (bimatoprost 0.03%/timolol 0.5%) ophthalmic solution to include a new preservative-free formulation in single-dose containers.
This marketing authorisation covers all 27 countries in the EU. GANFORT® is licensed for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.(1) The preservative-free unit dose (UD) formulation of GANFORT® will be made available in the UK from mid-September 2013. GANFORT® UD is the first preservative-free prostaglandin fixed combination glaucoma treatment to be made available in the UK and the rest of Europe.
“Sensitivity or intolerance to preservatives added to ophthalmic eye drops can be problematic for some patients, particularly if they use multiple daily drops or have been taking daily drops for a number of years. The availability of a preservative-free formulation of GANFORT® is welcomed and will help me to treat my patients who are not meeting IOP targets with a monotherapy and have issues with preservatives,” said Prof. Andrew McNaught from Gloucestershire Hospitals NHS Foundation Trust.
The licence is based on results from a 12-week clinical study, in which GANFORT® UD was shown to be non-inferior and to have equivalent efficacy to the multi-dose formulation, with the difference in mean IOP lowering in the worse seeing eye being less than 0.4 mm Hg between the two treatments.(1) Treatment-related adverse events were similar, with both products having a low incidence of burning or stinging and the discontinuation rates were low.(1)
Preservatives are normally added to eye drops to prevent contamination from bacteria. However, a small number of patients are not able to tolerate these preservatives, particularly if they are using multiple eye drops, have used drops for many years or have certain ocular surface conditions. The new formulation of GANFORT® is delivered as a single dose so that a preservative is not needed. Additionally, GANFORT® preservative-free eye drops do not require refrigeration and the patients can choose to use their medication in the morning or in the evening.(1)
“As a leader in the ophthalmology specialty area, Allergan is proud to offer patients in the United Kingdom this first prostaglandin fixed-combination treatment for glaucoma which is also free from preservatives. This new formulation provides a meaningful addition to our already well-established portfolio of effective glaucoma treatments,” said Martin Gillen, Country Manager for the UK & Ireland at Allergan.
GANFORT® UD consists of two active substances: bimatoprost and timolol. These two components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone. GANFORT® UD has a rapid onset of action.(1)
- GANFORT® (bimatoprost/timolol ophthalmic solution 0.03%/0.5% in a single dose container) Summary of Product Characteristics.