NEW Sodium Hyaluronate 0.15% with Xanthan Gum 1%

Transcription

1 NEW Sodium Hyaluronate 0.15% with Xanthan Gum 1% Unique patented formula gives extended protection of the ocular surface for moderate to severe dry eye Sodium Hyaluronate 0.15% For immediate and long lasting relief for dry or irritated eyes

2 Properties of Unique patented formula gives of the ocular surface for moderate to severe dry eyes and wetting properties and * properties for good ocular retention time * Physical chacteristics enabling change from being more viscous and then more fluid in nature and vice-versa. properties (involved with initiating epithelial cell growth) properties (demonstrating characteristics of the mucus layer of the tear film) gel formulation

3 INDICATIONS DRY EYE night lubrication post surgery eye injuries mild, moderate and severe dry eye moderate and severe dry eye day time use lubrication for contact lens wearers

4 INDICATIONS DRY EYE The Lacrimal Functional Unit and reasons for Dry Eye Syndrome For more information visit:

5 INDICATIONS DRY EYE Diagnostic and Therapeutic Pathway Major etiological causes of dry eye 1 Diagram adapted from DEWS 2007 Report

6 EFFICACY MODE OF ACTION contains 2 natural polymers, Xanthan Gum and Sodium Hyaluronate The inclusion of Xanthan Gum helps prolong the contact time of with the ocular surface, giving sustained protection and enhancing the properties of Sodium Hyaluronate. Title: Mean Residual Activity on the Ocular Surface after instillation of 25ul of 0.5% Pilocarpine eye drops containing Xanthan Gum 0.3% against reference solution of just 0.5% Pilocarpine eye drops 2 % of solution present on the surface of the eye Eye drops with Xanthan Gum Reference eye drops Time (min) RESIDUAL ACTIVITY

7 EFFICACY MODE OF ACTION The physical characteristics and gel formulation of makes it particularly suitable for: process following wounds or abrasions Title: The change in area of Epithelial Defect (lesion) from Day 1 to Day 3 following treatment 3 REVEAL STUDY & RESULTS Mean area of Epithelial defect Day 1 12 hrs patching + eye gel 3 days patching + eye ointment * * Day 3 *P<

8 EFFICACY MODE OF ACTION Xanthan Gum is also able to demonstrate characteristics of the naturally occurring mucus layer of the tear film. This can be described as Mucomimetic properties. This property was investigated in a study comparing the muco-adhesive performance of certain marketed ophthalmic gels. 4 The muco-adhesive performance was measured using a tensile strength test method. Mucin formulation interaction 4 Viscosity Gel Formulation Ointment Ointment Strength of molecular interaction The turquoise column shows a high affinity between and tissue mucins, an indication of a more prolonged ability to stay on the surface of the eye than other gel formulations and ointments possesses an ideal viscosity, between that of the eye drops and ointment, which reduces the sensation of a foreign body and ensures maximum tolerability Among the tested formulations, Xanthan Gum showed the strongest muco-adhesion and indicated a low degree of hardness and high degree of elasticity. This should be predictive of good patient compliance with Xanthan Gum formulations allowing for prolonged ocular contact time, no blurry vision and good spreadability.

9 PROBLEM EFFICACY/MOA PATIENT SUMMARY REFERENCES EFFICACY MODE OF ACTION and contain Sodium Hyaluronate - A naturally occurring, large polymer molecule Main properties 1. Water retaining and wetting properties The intermolecular spaces of Sodium Hyaluronate fill up with water molecules from the aqueous layer of the tear film. This acts like a sponge, holding water and giving longlasting wetting of the ocular surface Viscoelastic and pseudoplastic properties Sodium Hyaluronate viscosity decreases during blinking enabling it to coat the entire surface of the eye and also helps in reducing friction on the ocular surface. In the non-blinking eye, initial viscosity is recovered, prolonging the retention time compared to other artificial tears. 6 Epithelial Cell Loss Re-establishment of Epithelial Cells 3. Re-epithelialisation properties Sodium hyaluronate has been shown to foster the migration of corneal epithelium cells. This ability for stimulating epithelial cell proliferation might partly explain its potential for promoting corneal epithelial wound healing. 7

10 EFFICACY MODE OF ACTION Xanthan Gum contains a mixture of 2 natural polymers, Xanthan Gum and Sodium Hyaluronate. Xanthan Gum attaches to and mixes with the mucus layer of the tear film. This in turn allows for Sodium Hyaluronate to have a more prolonged contact on the ocular surface. This provides sustained lubrication, hydration and protection of the ocular surface. and Mucus Layer Interaction Water Xanthan Gum Mucus layer Sodium Hyaluronate CD44 Receptor (CD44 is a cell surface molecule involved in cell migration) A combination of Sodium Hyaluronate and Xanthan Gum increases effectiveness of in terms of:

11 EFFICACY MODE OF ACTION : Molecular Representation Xanthan Gum Hyaluronic acid Water molecule Aqueous-mucus layer After instillation in the conjunctival sac, mixes with tears and forms a lubricating viscous and transparent layer, which reduces friction due to eye movements and blinking and alleviates the symptoms of ocular dryness due to environmental and climatic conditions such as pollen, dust, glare, pollution and computer monitor use.

12 PRODUCT HOW TO USE For moderate and severe dry eye Preservative-free Single dose units Composition 1.5 mg Sodium Hyaluronate, 10 mg Xanthan Gum, Sodium Chloride, Potassium Chloride, Magnesium Chloride Hexahydrate, Calcium Chloride Dihydrate, Disodium Phosphate Dodecahydrate, Monobasic Sodium Phosphate Monohydrate, Sodium Citrate, Glycerol, Purified Water. Presentation Each single dose unit contains 0.4ml of sterile There are 20 single-dose units in each carton. without preservative. Use and Storage Each single-dose unit must be used immediately after opening. Any residual product should not be used. The single-dose containers must be used within 12 weeks from opening the aluminium pouch. Store below 30 C. Administration Instil one drop of in the conjunctival sac. Unless otherwise directed by your ophthalmologist, it is possible to administer the product up to 4 times daily.

13 PRODUCT HOW TO USE For mild, moderate and severe dry eye Preservative-free Single dose units Suitable for Contact Lens Wearers Composition 1.5mg of Sodium Hyaluronate. The other ingredients are Sodium Chloride, Disodium Phosphate Dodecahydrate, Monobasic Sodium Phosphate Monohydrate and Purified Water. Presentation Each single unit dose contains 0.3ml of sterile Sodium Hyaluronate 0.15% eye drops without preservative. There are 20 single unit doses in each carton. Use and Storage Each single dose unit to be used once only and then discarded. Please dispose of each single unit dose after use in an environmentally friendly way. Store below 30 C. Do not use after the expiry date printed on the box. Administration Instil 1-2 drops four times a day in any conjunctival sac (inside the lower eyelid). Avoid touching the eye or any surface with the tip of the container. If the drop of medication is not retained for any reason, another drop should be instilled. Leave an interval of at least 10 minutes before the instillation of another eye drop.

14 PRODUCT HOW TO USE Flick then Click 1 Wash your hands. Pull apart the single-dose container from the strip. Before use make sure that the single-dose container is intact. 2 Shake the single-dose container at an angle until the Gel moves towards the tip. 3 Hold the single-dose container from the lower part. Open a single-dose unit by twisting and pulling off the cap. 4 Carefully pull down the lower eyelid to form a space between the eye and the eyelid. Gently squeeze a drop of or into the eye but do not touch the eye with the tip of the container. Close the eye for 30 seconds then open your eyes and blink a few times. Repeat these instructions for the other eye if required. Wash your hands.

15 ORDER NOW MOORFIELDS PHARMACEUTICALS NEW Sodium Hyaluronate 0.15% with Xanthan Gum 1% How to obtain and, and can be ordered from pharmaceutical wholesalers such as AAH, Alliance, Sangers and Phoenix as well as directly through our Customer Service Team., our products are available to order from Mid Optic or Three-Sixty., and are also available on prescription from your GP or Ophthalmologist. You can purchase and online or in any pharmacy.

16 ORDER NOW MOORFIELDS PHARMACEUTICALS Moorfields Pharmaceuticals is the manufacturing arm of Moorfields Eye Hospital NHS Foundation Trust. We have provided products in response to clinical needs for over 50 years and supply approximately 100 ophthalmic specials and have a growing portfolio of branded licensed products. t: +44 (0) (option 1) f: +44 (0) pharmaceuticals@moorfields.nhs.uk

17 References Report of the International Dry Eye Workshop (DEWS), The Ocular Surface, April 2007, Volume 5, No.2. 2 Meseguer G, et al., Gamma Scintigraphic comparison of eyedrops containing pilocarpine in healthy volunteers. Journal of Ocular Pharmacology and Therapeutics 1996; Volume 12, Number 4: Faraldi F, et al., A new eye gel containing Sodium Hyaluronate and Xanthan Gum for the management of post-traumatic corneal abrasions. Clinical Ophthalmology 2012; 6: Mazzone MG, et al., Evaluation of mucoadhesive properties of Xanthan Gum hydrogels versus marketed ophthalmic gel formulations using a tensile strength method. ARVO Masatsugu Nakamura et al; Characterisation of Water Retentive Properties of Hyaluronan; Cornea 1993; 12(5): Snibson G. R. et al., Ocular surface residence times of artificial tear solutions. Cornea 1992; 11(4): P. Aragona et al., Long term treatment with Sodium Hyaluronate - containing artificial tears reduces ocular surface damage in patients with dry eye. Br J Ophthalmology 2002; (86):