Download Lubricating Eye drops APC Verdict Medicine Review Summary

May 2013 Systane® Balance & Optive Plus®
North Staffordshire and Stoke-on-Trent Area Prescribing Committee
Medicine Review Summary
Lubricating eye drops (Systane® Balance & Optive Plus®)
Verdict:
Formulary inclusion:
Formulary category:
Restrictions:
Reason for inclusion:
Link to formulary:
Link to medicine review
summary:
Link to full review:
Systane® Balance and Optive Plus® are to be added to the North Staffordshire Joint
Formulary
Amber 2
Recommendation by Consultant Ophthalmologist only
The committee was satisfied with evidence for efficacy and safety, cost implications and
intended place in therapy.
Primary care: http://www.medicinesmanagementstoke.nhs.uk/north_staffs.html
Secondary care: Trust Intranet→ Clinicians→ Support services → Pharmacy →North
Staffordshire Joint Formulary
Primary care: http://www.medicinesmanagementstoke.nhs.uk/Formulary_Focus.html
Secondary care: Trust Intranet→ Clinicians→ Support services → Pharmacy →Link to
Joint formulary Related Documentation→ North Staffordshire Area Prescribing
Committee New Medicine Reviews & Verdict Sheets
Primary care: http://www.medicinesmanagementstoke.nhs.uk/Formulary_Focus.html
Secondary care: Trust Intranet→ Clinicians → Support Services → Pharmacy → Joint
Formulary Related Documents → Reviews, Guidelines & Essential Shared Care
Guidelines → NSHE Drug Reviews
Review summary:
Formulary application:
Systane® Balance & Optive Plus® were reviewed for inclusion on the North Staffordshire Joint Formulary by the
New Medicines Committee; Ms. Anupama Pherwani (UHNS Consultant Ophthalmologist) attended the meeting on
7th May 2013 to support the application.
Intended local place in therapy:
Optive Plus® is targeted to patients with specific type of dry eyes called evaporative dry eye while the Systane®
Balance is intended to replace Systane® and to be used for patients with meibomian gland dysfunction.
Related guidance: N/A
Optive Plus® has castor oil that gives it the advantage of having a lipid enhancing effect which reduces tear
evaporation, providing an extra layer of protection hence improving the quality of tears.1 The castor oil mimics the
natural lipids in the tear film. 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. It prevents separation in the bottle and also acts as
viscosity agent.2 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.3 The long-lasting comfort and
extra action is most suited to patients with moderate to severe dry eye.
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
Author: Sr Maria Chidiamara Njoku
Date approved by APC: 22/05/13
Page 1 of 2
May 2013 Systane® Balance & Optive Plus®
North Staffordshire and Stoke-on-Trent Area Prescribing Committee
Medicine Review Summary
(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.4 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.
Korb et al.5 evaluated the performance of Systane® BALANCE ability to restore lipid layer thickness (LLT) in
comparison to Soothe XPTM lubricant eye drops in a randomised, double blinded, single dose contralateral eye 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.
Cost:
Product
6,7
Primary Care (ex VAT, C+D )
Price per pack
Optive Plus®
£7.49
Systane ® Balance
£7.49
Reference:
1
OPTIVE PLUSTM IFU
OPTIVE® Natural tear comparison, Data on file, Allergan.
3
OPTIVE® Efficacy measures, Data on file, Allergan.
4
Data on file, Allergan, inc. CSR 9965-002.
5
Korb D et al. Evaluation of extended tear film stability by two emulsion-based artificial tears. Poster presented at 6th International conference Tear Film and Ocular Surface. Basic
Science and Clinical Relevance. September 22-25, 2010. Florence, Italy.
6
C+D Chemist +Druggist February 2013 Vol 54:2. Accessed via www.chemistanddruggist.co.uk
7
Drug Tariff – April 2013. Accessed via https://www.drugtariff.co.uk
2
Author: Sr Maria Chidiamara Njoku
Date approved by APC: 22/05/13
Page 2 of 2