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Trends in licence approvals for ophthalmic medicines in the United Kingdom
- Source :
- Eye
- Publication Year :
- 2020
- Publisher :
- Springer Science and Business Media LLC, 2020.
-
Abstract
- Objectives The grant of marketing authorisation (MA) for new medicines requires comprehensive assessment by regulatory authorities. This study sought to identify ophthalmic medicines granted United Kingdom MA and consider trends in licence approvals. Methods This retrospective study reviewed published lists of products granted MA by the UK Medicines & Healthcare products Regulatory Agency between January 2001 and December 2018, inclusive. Eye drops and medicinal products intended for ophthalmic use were identified. All regulatory data sources consulted are in the public domain. Data analyses were descriptive. Results A total of 295 MAs were issued for ophthalmic products between 2001 and 2018, inclusive. Of these 229 (78%) were for single-active substances and 66 (22%) fixed-dose combination (FDC). Approvals for products with single-active substance included ocular hypotensives (115; 50%), antibiotics (48; 22%), allergy medicines (30; 13%), lubricants (18; 8%) and anti-inflammatories (11; 5%). Approvals for FDCs were predominantly ocular hypotensives (56; 85%), with timolol combined with carbonic anhydrase inhibitors (27; 48%) and prostaglandin analogues (26; 46%) accounting for the majority of glaucoma FDCs. Other FDCs were approved for antibiotic/inflammatory (5; 7.5%), pupillary mydriasis (2; 3%), allergy (2; 3%) and ocular surface lubrication (1; 1.5%) products. A median of 16 licences were approved per year (range 7 [2005] to 35 [2011]). Conclusions The majority of MAs granted were for single-agent products, particularly ocular hypotensives and antibiotic preparations. Most products were generic versions of well-established active substances. A trend for increased approvals for FDCs is evident, particularly for the treatment of raised IOP.
- Subjects :
- medicine.medical_specialty
Pharmaceutics
business.industry
Authorization
Timolol
Glaucoma
Article
United Kingdom
03 medical and health sciences
Ophthalmology
0302 clinical medicine
Internal medicine
030221 ophthalmology & optometry
medicine
Humans
Drug therapy
Regulatory agency
Ophthalmic Solutions
business
Licensure
Ocular surface
Ophthalmic use
030217 neurology & neurosurgery
Retrospective Studies
medicine.drug
Subjects
Details
- ISSN :
- 14765454 and 0950222X
- Volume :
- 34
- Database :
- OpenAIRE
- Journal :
- Eye
- Accession number :
- edsair.doi.dedup.....c19e982acd21e325fdc4700879c033a1