Over-the-Counter (OTC) Treatments for Dry Eye

The Science Behind Products to Treat Dry Eye

The tear film is a wonder of physics that performs a number of functions critical to corneal and conjunctival health.  (See our “mini-monograph” on the normal tear film under “Resources”).  The wonder aspect has to do with the thinness of the film spread over a large surface area (your exposed eye).  Water simply doesn’t like spreading itself so thin.  Yet the hydrophilic cell surface, and a thin layer of meibomian gland lipid sealing in the moisture layer allow this thin layer to occur. 

Ocular discomfort and pain associated with mild to moderate dry eye are always linked to some instability in this delicate moisture layer leading to its disruption before the next blink.  This leaves the eye unprotected and susceptible to dryness which triggers a cascade of problems.  Dry eye can occur due to insufficient tear production (aqueous-deficient), or defective meibomian secretion, either of which leave the eye unprotected.


Many over-the-counter (non-prescription) eye drops for treatment of dry eye discomfort attempt to restore stability to the tear film, or sooth the inflamed ocular surface.  These products are a rapidly expanding sector of the ocular pharmaceutical business due to the aging population and the amount of time we all spend looking at computer monitors.  These products would appear to be simple.  Yet market leading products are sophisticated in terms of new “gentle” preservatives, novel polymers to enhance corneal surface wettability, and approaches to augmenting the lipid layer.   


Over-the-counter eye drops in the US are “regulated” by adherence to the Code of Federal Regulations monograph on these products.  Development of new products in this area requires care to stay within the scope of the OTC monograph while allowing for innovation that will differentiate the new product from competitors.  Navigating this complexity requires a comprehensive understanding of the competitors in this space, the regulatory environment, and the special requirements for this class of products.





  

The Davio Pharma Consulting Difference


For many companies over-the-counter (OTC) eye drops are the ticket to enter the ocular pharmaceutical market.  Time and costs to develop these products are less than for Rx or generic products.  Davio Pharma Consulting has significant experience in the OTC dry eye space, both in US and EU products. 

Our value in this area begins with a current understanding of the tear film.  We use this knowledge and your company’s product concept to devise a strategy to differentiate your product from the competition.  We then use our extensive development experience in these products to formulate an efficient plan for development, maximizing your internal and external resources to launch a reliable, marketable product in the shortest realistic timeframe.
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