Are generic topical prostanoids the way forward in the care of glaucoma patients? – Yes

Titcomb, Lucy

doi:10.1038/eye.2013.124

Cited by 5 publications

(7 citation statements)

References 6 publications

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“…A key advantage of generic/hybrid medicines is the potential for cost saving with generic products. For latanoprost alone, the reducing price of products and increased generic prescribing practices are reported to save the NHS in excess of £32 million per annum [ 24 ]. However, potential disadvantages associated with generic/hybrid eyedrops are the differences in packaging and presentation or storage instructions which may interfere with an established patient familiarity with the originator product.…”

Section: Discussionmentioning

confidence: 99%

Trends in licence approvals for ophthalmic medicines in the United Kingdom

Morgan-Warren¹,

Morarji²

2020

Eye

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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.

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Section: Discussionmentioning

confidence: 99%

Trends in licence approvals for ophthalmic medicines in the United Kingdom

Morgan-Warren¹,

Morarji²

2020

Eye

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“…and patients should be informed of potential changes to their medication. It is also important to emphasise to patients that generics are authorised off patent versions of branded medications as not all patients appreciate the difference between generic and counterfeit medicines [45].…”

Section: Perceptions Of Generic Medicationsmentioning

confidence: 99%

The Use of Generic Medications for Glaucoma

Tatham

2020

Journal of Ophthalmology

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The use of generic medicines has grown considerably in recent years providing considerable cost savings. In England, generic items represented 11.7% of prescriptions for glaucoma and ocular hypertension in 2009, increasing to 55.2% of prescriptions in 2018. Generics can be brought to the market quickly and at low cost as manufacturers are not required to repeat animal or clinical research on active ingredients already approved for safety and efficacy. Although there is no regulatory requirement for studies comparing branded and generic eye drops, several randomised crossover studies have been performed comparing branded and generic prostaglandin analogues. While most have shown similar intraocular pressure lowering, studies are of short duration and have not evaluated visual field endpoints. Furthermore, differences in inactive ingredients, pH, viscosity, levels of particulate matter, and degradation over time have been reported. Other potential problems with generic eye drops include differences in bottle design affecting adherence, problems with supply, and the possibility that reduced revenue for innovator companies will lead to reduced investment in new drug development. This article reviews the potential advantages and disadvantages of generic antiglaucoma medications.

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“…; Heiligenhaus & Steuhl ). Among the available local treatment options, topical corticosteroid use may be limited by side effects, including potential recurrence of herpetic disease, increased intra‐ocular pressure (IOP), development of glaucoma, and cataracts (Titcomb ; Zanjani et al. ).…”

Section: Introductionmentioning

confidence: 99%

Topical cyclosporine‐A versus prednisolone for herpetic stromal keratitis: a randomized controlled trial

Peyman

Nayebzadeh

Peyman

et al. 2018

Acta Ophthalmologica

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Purpose: To compare topical cyclosporine-A 2% eye drop (Cs-A) with prednisolone acetate 1% eye drop for treatment of herpetic stromal keratitis (HSK). Methods: In this randomized clinical trial, 38 eyes of 33 patients with HSK were randomly assigned to receive either 2% Cs-A or 1% prednisolone acetate eye drops. All subjects received oral acyclovir 400 mg twice a day. Slit-lamp examination, Scheimpflug tomography corneal optical densitometry (Pentacamâ, Oculus Inc., Wetzlar, Germany), best-corrected visual acuity (BCVA), and intra-ocular pressure (IOP) were evaluated at the first visit, and 14 and 30 days after the treatment. Results: Within-group analysis revealed significant improvement of total cornea optical density after 30 days of treatment in both groups (30.3 AE 10.5 to 28.3 AE 9.8, p < 0.001 for prednisolone group, and 30.5 AE 8.8 to 28.8 AE 8.3 p < 0.001 for Cs-A group, mean AE SD). We were not able to disclose any significant difference between the two groups regarding the improvement of cornea optical density (p = 0.66). Best-corrected visual acuity (BCVA) logMAR significantly improved in both groups after 30 days of treatment (0.20 AE 0.52, p = 0.002 in prednisolone group, and 0.24 AE 0.31, p < 0.001 in Cs-A group, mean AE SD). Analysis between groups did not show a significant difference of BCVA improvement (p = 0.45). We did not observe any severe side effect attributable to drugs. Conclusions: Cs-A 2% and prednisolone acetate 1% topical eye drops are effective for treatment of HSK.

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Are generic topical prostanoids the way forward in the care of glaucoma patients? – Yes

Cited by 5 publications

References 6 publications

Trends in licence approvals for ophthalmic medicines in the United Kingdom

Trends in licence approvals for ophthalmic medicines in the United Kingdom

The Use of Generic Medications for Glaucoma

Topical cyclosporine‐A versus prednisolone for herpetic stromal keratitis: a randomized controlled trial

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