Download Lubricating eye drops update NMC Briefing Full Review

New Medicines Committee Briefing
May 2013
Lubricating Eye drops addition
Optive Plus® and Systane® BALANCE are to be reviewed for use within:
Primary Care
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Secondary Care
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Formulary application:
Consultant submitting application:
Ms Anupama Pherwani
(Consultant Ophthalmologist)
Clinical Director supporting application: Gareth Rowland (Clinical Director)
Lubricating eye drops have recently been reviewed and approved (enclosed below). Dr Pherwani
requested that Optive Plus® and Systane® Balance be included into the Joint formulary. She stated
that the Optive Plus® contains castor oil 0.25% which results in lipid-layer enhancement and
protection as well as increase viscosity. Systane® Balance contains hydroxypropyl guar that
facilitates rapid and uniform distribution across the damaged ocular surface and ensures minimal
blurring of vision on application.
Optive Plus® 1,2
Currently on the formulary is Optive® which is similar to Optive Plus® as they both contain
carmellose sodium 0.5% and used for treatment of symptoms of dry eye. The difference in the two is
the additional castor oil that gives Optive Plus® the benefit in lipid enhancing effect that reduces tear
evaporation and provides an extra layer of protection. This accounts for its triple mechanism of
action. Optive Plus® improves the quality of tears.3 The castor oil mimics the natural lipids in the
tear film.4 When released into the tear film, the lipid component (castor oil) will diffuse to the
surface to enhance and stabilise the tear film’s own lipid layer. Optive Plus® also contains
Polysorbate-80 that optimises the way the lipid component is delivered to the eye. This is a
surfactant and a salt-sensitive polymer that works together to hold the lipid component in the
formulation, prevents separation in the bottle and acts as viscosity agent. When the product is
administered to the eye, salts in the tear film allow the lipid component to be released so that it can
quickly and efficiently supplement the tear film’s lipid layer. The long-lasting comfort and extra
action is most suited to patients with moderate to severe dry eye.
The cost of Optive Plus® and Optive® are £7.49.5
1
Systane® BALANCE
Systane® BALANCE is a lipid based lubricating product for the treatment of dry eye. It is indicated for
the temporary relief of burning and irritation due to dryness of the eye for patients with Meibomian
Gland Dysfunction (MGD). Patients with MGD may experience dry eye due to a drop in the quantity
of meibomian gland secretions, obstruction or even loss of meibomian glands. Systane® BALANCE
lubricates the ocular surface, supplementing and stabilizing the lipid layer of the tear film; resulting
in increased lipid layer thickness and tear film break-up time. Systane® BALANCE contains an anionic
polar phospholipid, mineral oil, hydroxypropyl guar and a demulcent. The anionic polar
phospholipids keep the oil droplets suspended within the aqueous base. The low viscosity facilitates
rapid and uniform distribution across the damaged ocular surface and ensures minimal blurring of
vision on application.
Clinical efficacy
Korb et al. evaluated the performance of Systane® BALANCE ability to restore lipid layer thickness
(LLT) in comparison to Soothe XPTM lubricant eye drops. This was a randomised, double blinded,
single dose contralateral eye study in 40 patients. Single drop of test or control solution was
administered into the right eye after baseline data were collected. LLT thickness was recorded at 1,
5, 15, 60, 120 minute points. Method was repeated after the two hour testing period with the left
eye and the alternate, untested solution.
The authors also evaluated the ability of Systane® BALANCE to improve tear film break up time
(TFBUT), visual clarity following application and patient’s perception on comfort and acceptability.
This was done by taking a 3 minute haze profile (analysis of vision clarity) immediately after instilling
drop at 30 second intervals. A ten point visual analogue scale of comfort and acceptability was used
to question patient perception of drop comfort and acceptability. TFBUT was recorded at 15, 30, 60
and 120 minute points.
There was a statistically significant improvements in the mean LLT at the 5, 15, 60 and 120 minute
points (p=0.015, 0.0011, 0.0001 and <0.0001 respectively) in the patients treated with Systane®
BALANCE compared to control treated eyes. The authors concluded that Systane® BALANCE
lubricating eye drop resulted in statistically significantly thicker LLT during a 2 hour testing period
compared with control lubricant eye drops.
The cost of Systane® Balance is £7.49
References:
1
OPTIVE® Efficacy measures, Data on file, Allergan.
TM
OPTIVE PLUS IFU
3
OPTIVE® Natural tear comparison, Data on file, Allergan.
4
Data on file, Allergan, inc. CSR 9965-002.
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Drug Tariff – April 2013. Accessed via https://www.drugtariff.co.uk
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Updated by :
Sr Maria Chidiamara Njoku
Primary/Secondary Care Interface Pharmacist
University Hospital of North Staffordshire
Stoke-on-Trent
Email: [email protected]
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