TSP (Tamarindus indica seed polysaccharide) Eye Drops, daily dose units, 1%, 0.5 mL, 20, Visine Professional Intensive Dry Eye Daily , July 2007
Public summary document for TSP (Tamarindus indica seed polysaccharide) Eye Drops, daily dose units, 1%, 0.5 mL, 20, Visine Professional Intensive Dry Eye Daily, July 2007
Page last updated: 26 October 2007
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Public Summary Document
Product: TSP (Tamarindus indica seed polysaccharide) Eye Drops, daily dose units,
1%, 0.5 mL, 20, Visine Professional Intensive Dry Eye Daily
Sponsor: Johnson and Johnson Pacific Pty Ltd
Date of PBAC Consideration: July 2007
1. Purpose of Application
The submission sought listing of a new form of eye drops for the treatment of severe dry eyes for people who are sensitive to preservatives.
2. Background
This medical device had not previously been considered by the PBAC.
3. Registration Status
These eye drops are registered as a medical device for the relief of severe dry eyes.
4. Listing Requested and PBAC’s View
Authority Required
Severe dry eye syndrome, including Sjogren’s syndrome, in patients who are sensitive
to preservatives in multi dose eye drops.
The PBAC noted the listing would appear appropriate for inclusion under the streamlined
authority arrangements.
5. Clinical Place for the Proposed Therapy
The eye drops are designed to treat severe dry eye syndrome, including Sjogren’s syndrome, in patients who are sensitive to preservatives in multi dose eye drops. This syndrome occurs in older people and women who have a reduction in tear fluid in the eye.
6. Comparator
The submission nominated multi dose Cellufresh which contains 5 mg/mL (0.5%) carmellose
sodium single dose units as the main comparator.
In the absence of trials comparing TSP with carmellose, the submission provided a
clinical comparison with Systane eye drops containing polyethylene glycol 400 with
propylene glycol.
7. Clinical Trials
The submission provided details of 4 unpublished and 12 published clinical studies
providing support for the efficacy and safety of TSP daily dose units.
The key trials which had been published at the time of submission are as follows:
|
Trial/First Author |
Protocol title |
Publication citation |
|---|---|---|
|
Bonci e et al |
The use of a new generation lacrimal substitute in dry eye syndrome |
Bollettino di Oculistica Anno 83, N4, 1-11, 2004 |
|
Bux AV et al |
Comparison between two artificial tear substitutes in contact lens wearing |
Ato Aggionamenti di Terapia Ottalmica 55(1): 4-9 2003. |
|
Lindsay B. et al |
A scintigraphic investigation of the precorneal residence time of TS polysaccharide formulations in mild to moderate KCS patients |
J Pharm Pharmacol, 54 (supplement) 2002 |
|
Mannucci LL. et al |
Use of a new lachrymal substitute (TS polysaccharide ) in contactology |
J Med. Contactology and low vision 1/1:6-9, 2000 |
8. Results of Trials
These trials support that the eye drop is:
- Long lasting;
- Provides improvement in clinical signs and symptoms of dry eye;
- Compatible with contact lenses ; and
- Has mucomimetic properties.
9. Clinical Claim
The submission claimed that in a comparative trial, Systane and TSP daily dose units
were found to have a similar efficacy and safety profile. The submission claimed that
TSP daily dose units offers the patient up to 12 drops per day where other single
dose units are only reimbursed to 3 doses per day.
The submission also claimed that each vial could be used for up to 12 hours based
on a study of microbiological contamination undertaken in Italy.
The PBAC accepted this claim, see Recommendation and Reasons.
10. Economic Analysis
The submission stated that as no efficacy superiority is claimed for TSP daily dose units, no economic evaluation had been undertaken.
11. Estimated PBS Usage and Financial Implications
The number of scripts dispensed was estimated by the submission to be in the range
10,000 – 50,000 in year 4 of listing.
The cost to the PBS was estimated by the submission to be < $10 million in year 4
of listing. The submission claimed that there may be no additional costs to the PBS
if this product replaced other single dose unit dry eye preparations.
12. Recommendation and Reasons
The PBAC recommended the authority required listing of tamarindus indica seed polysaccharide
(TSP) on the PBS on a cost-minimisation basis compared with carmellose sodium eye
drops (Cellufresh) 5 mg per ml, single dose units. The PBAC noted TSP eye drops contained
no preservative and were designed for use over 12 hours, and recommended that the
equi-effective doses were 2 units of TSP eye drops daily (24 hours) and 3 units of
Cellufresh daily (24 hours).
The PBAC accepted that TSP eye drops were as efficacious and as well tolerated as
Systane eye drops (polyethylene glycol 400 with propylene glycol) in the treatment
of severe dry eye syndrome. The Committee also recalled that the listing of all dry
eye preparations had been made on the basis of similar efficacy and safety.
The PBAC recommended the listing would be appropriate for listing under the streamlined
authority arrangements.
The PBAC recommended the 20 day safety rule should not apply.
Recommendation
TSP (Tamarindus indica seed polysaccharide) Eye Drops, daily dose units, 1%, 0.5 mL,
20
Restriction: Authority required
Severe dry eye syndrome in a patient who is sensitive to preservatives in multi dose
eye drops.
Maximum quantity: 3 (x 20)
Repeats: 5
13. Context for Decision
The PBAC helps decide whether and, if so, how medicines should be subsidised in Australia. It considers submissions in this context. A PBAC decision not to recommend listing or not to recommend changing a listing does not represent a final PBAC view about the merits of the medicine. A company can resubmit to the PBAC or seek independent review of the PBAC decision.
14. Sponsor’s Comment
This summary is an accurate reflection of the application.
