Dry Eye Disease (DED)
Fundamental requirements of the tear film are to keep the underlying cornea moist while providing a smooth and even surface to ensure unhindered light entry into the eye. To achieve this the structure of the tear film is highly complex consisting of three discrete layers:
- The Mucin Layer: mucin attaches to the cornea allowing the middle aqueous layer to spread evenly over the eye.
- The Aqueous Layer: keeps the eye moist and helps to flush out foreign objects.
- The Lipid Layer: the thin smooth layer which aids clear vision while limiting evaporation from the underlying aqueous layer.
The consequences of DED are multiple including symptoms of discomfort, burning and of grit in the eye. Visual disturbance is common with potential for damage to the cornea including long-term scarring and subsequent loss of vision. In severe cases Filamentary Keratitis can develop. This is a painful lesion where mucus filaments stick to the corneal surface and with each blink, the eyelids tug at the filaments, stimulating pain-sensitive corneal nerves.
DED occurs when there is either insufficient tear production to maintain the aqueous layer or the lipid layer is deficient allowing the eye to dry due to increased evaporation. The latter is the more common cause of DED. The lipid layer thus is crucial to good vision and corneal integrity. It consists of a complex mixture of lipids which are generated form the lacrimal (tear) gland and the Meibomian glands in the eyelids (Tear and Meibum Lipidomes). Importantly, all of these lipids are present in Lamelleye (CXB/1-14).
Given the importance of these lipids to the tear film, Lamellar has created an extensive research program with Glasgow Caledonian Vision Sciences. This includes the following clinical studies:
- A double blind, randomized, 12 day, cross-over study testing Lamelleye and placebo in 24 subjects with DED.
- A study of 7 days therapy with CXB/1-14 in the treatment of subjects with Filamentary Keratitis.
- A single dose, double blind, randomized cross-over study of three doses of CXB/1-14 and placebo in 14 healthy volunteers with environmentally induced DED.
- A double blind, randomized, 7 day, 4 way cross-over study testing 3 doses of CXB/1-14 and placebo in 24 subjects with Sjogrens.
The market for dry eye products is large and growing encompassing prescription and OTC products which in aggregate generate sales in excess of $2billion per annum. In this market “a broad spectrum of formulations is available as artificial tears and ocular lubricants. Most products, however, offer only symptomatic and short-term relief” (Scrip 2011: The Ophthalmic Pharmaceutical Market Outlook to 2016).