Medical Devices Sterile Eye Drops Solution Eye Lubricant (Class IIb)

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1 Fardi medicals developed a wide range of eye drops to treat Dry Eye symptoms quickly and effectively. Our products are available in convenient multidose and unidose containers. Thanks to the multidose closing tip system velia, which use a nonreturn valve combined with a silicone membrane venting system, makes possible to deliver safe, multidose preservative free eye drops. Figure 1. velia container Figure 2. Unidose container Our portfolio of eye drops contains eight different models of Sterile Eye Drops solutions classified into six main groups depending on the main substance (lubricant) contained: Hypromellose, Sodium Hyaluronate, Carmellose, Carbomer, Polyvinyl Alcohol, Polyethylene Glycol+Propylene Glycol. The intended use of the eye lubricants is to help relieving the symptoms of dry eye condition and tired eyes by lubricating and hydrating the surface of the eye. These drops also provide soothing relief from the discomfort caused by external factors such as wind, smoke, pollution, dust, dry heat, air conditioning, air travel or prolonged work in front of a computer screen. It is suitable for use by people who are sensitive to preservatives. In the following table it is shown the main characteristics of each product Product Name Sodium Hyaluronate 0.20% Sterile Eye Drops Eye Lubricants Available Contact Lenses Viscosity Main su bstance presentations compatibility* Range (mpas) Sodium Hyaluronate (0.15%) Yes Sodium Hyaluronate 0.15% Sodium Hyaluronate (0.20%) Hypromellose 0.3% Hydroxypropylmethyl cellulose (0.3%) POLYALCAT 1.4% Polyvinyl alcohol (1.4%) CARBOCAT 0.13% Carbomer (0.13%) OptiVision POLYGLIC Carmellose 0.5% Carboxymethyl cellulose sodium (0.5%) and glicerol (0.9%). Polyethylene glycol (0.4%), propylene glycol (0.3%) and hydroxypropyl guar (0.18%). Carboxymethyl cellulose sodium (0.5%) 0.5 ml Yes High viscosity ml *The compatibiliy between the product and contact lenses could be tested under client requirement. Delfy FDR GROUPS SL Calle Poliol 11, Poligono las matas, El Vendrell, Spain. Info@fardimedicals.com

2 SODIUM HYALURONATE 0.15% Sodium hyaluronate is a wellknown substance and has been used to provide tearlike The following are the properties of sodium hyaluronate do have a very important role in the treatment of dry eyes: Optimal water retention: as a sponge, it retains water and releases it progressively. Viscoelasticity and pseudoplasticity: increase the viscosity with eyelid opening and decrease the viscosity with eyelid closing. Mucoadhesivity: this property allows increasing the time of contact of the product with the ocular surface. Highly tolerated: sodium hyaluronate is highly tolerated because it is naturally presented in mammalian tissues. Sodium Hyaluronate 0.15% is compatible with the use of contact lenses. SODIUM HYALURONATE 0.20% Sodium hyaluronate is a wellknown substance and has been used to provide tearlike The following are the properties of sodium hyaluronate do have a very important role in the treatment of dry eyes: Optimal water retention: as a sponge, it retains water and releases it progressively. Viscoelasticity and pseudoplasticity: increase the viscosity with eyelid opening and decrease the viscosity with eyelid closing. Mucoadhesivity: this property allows increasing the time of contact of the product with the ocular surface. Highly tolerated: sodium hyaluronate is highly tolerated because it is naturally presented in mammalian tissues. Sodium hyaluronate 0.20% has been developed for the symptomatic relief of severe and persistent dry eye. Sodium Hyaluronate 0.20% is compatible with the use contact lenses.

3 HYPROMELLOSE 0.3% Hypromellose is a wellknown substance and has been used to provide tearlike The physical characteristics of hypromellose eye drops are similar to those of natural tears, providing lubrication to the surface of the eye. Hypromellose has shown many benefits to relieve the sensation of dryness in the dry eye population, some of which are: Increases tear meniscus volume. Reduce dry eye signs and symptoms (blurry vision, foreign body sensation, stinging, burning or scratchy sensation, dryness, pain/soreness and photophobia). Improve the stability of the lipid layer. Improve patient comfort. Provide protection of the ocular surface. Providing viscosity, increased oncotic pressure and have demulcent action. Hypromellose does not produce inflammation. It is very well tolerated in human corneas and coils. POLYALCAT POLYALCAT 1.4% act as Eye Lubricant alleviating dryness sensation or ocular fatigue due to external factors (such as wind, smoke, pollution, dust, dry heat, air conditioning, air travel, prolonged work in front of a computer screen, etc). It is used to moisten and lubricate the eyes surface. Polyvinyl alcohol is a biocompatible synthetic polymer that has low viscosity but optimal wetting characteristics at a concentration of 1.4%. The advantages of polyvinyl alcohol (PVA) as eye lubricant are that it is beneficial in lipid, aqueous and mucin layer deficiencies. Moreover, PVA is water soluble and does not cause blurring of vision.

4 CARBOCAT 0.13% Carbomers present many advantages for the ocular therapy. Due to its high viscosity, these formulations have a longer ocular residence time over more watery formulations and so permit more convenient dosing without impeding blinking or causing marked visual blur. Ophthalmic preparations containing carbomers show many benefits to relieve the sensation of dryness in the dry eye population, some of which are: Increases tear meniscus volume. Reduce dry eye signs and symptoms (blurry vision, foreign body sensation, stinging, burning or scratchy sensation, dryness, pain/soreness and photophobia). Improve the stability of the lipid layer. Improve patient comfort. Provide protection of the ocular surface. Provide viscosity, increase oncotic pressure and have demulcent action. Carbomer does not produce inflammation. It is very well tolerated in human corneas and coils. OPTIVISION OptiVision contains sodium carmellose as lubricant substance. Carmellose is one of the most common viscous polymers used in artificial tears to achieve the prolonged residence time on the ocular surface. In addition, it contains glycerin, which further protects epithelial cells from hypertonic stress. Ophthalmic preparations containing carmellose show many benefits to relieve the sensation of dryness in the dry eye population, some of which are: Highly tolerated Improve the symptoms of dry eye Greater mucoadhesive properties Comfortable

5 POLYGLIC POLYGLIC has been designed to increase ocular surface retention by adding the polymer hydroxypropylguar (HPGuar) as a gelling agent that is believed to mimic the mucin layer of the tear film. Also includes the demulcents polyethylene glycol 400 (0.4%) and polypropylene glycol (0.3%), both of which have been previously used in ophthalmic preparations to provide protection to the ocular surface microenvironment. Ophthalmic preparations containing polyethylene glycol show many benefits to relieve the sensation of dryness in the dry eye population, some of which are: Increases tear meniscus volume. Reduce dry eye signs and symptoms (blurry vision, foreign body sensation, stinging, burning or scratchy sensation, dryness, pain/soreness and photophobia). Improve the stability of the lipid layer. Improve patient comfort. Provide protection of the ocular surface. Providing viscosity, increased oncotic pressure and have demulcent action. It is very well tolerated in human corneas and coils. CARMELLOSE 0.5% Carmellose 0.5% contains sodium carmellose as lubricant substance and a mixture of ions, which emulate the physical characteristics of natural tears. Carmellose 0.5% is presented in a convenient singledose container which adapts the volume to the need of the particular use (sporadic use) and additionally makes more convenient its transportation and use outdoor. Ophthalmic preparations containing carmellose show many benefits to relieve the sensation of dryness in the dry eye population, some of which are: Highly tolerated Improve the symptoms of dry eye Greater mucoadhesive properties Comfortable