Tuesday 11 June 2019

A Dry Market With Plenty of Fertile Opportunities

In this modern day and time, where pharmaceutical innovation is in/extensively driven towards patient-centric approaches and broad range product promoting, it is almost impossible to find an overlooked yet fertile niche market. Nevertheless, there is still one out there that presents a wide array of opportunities for integrated research teams working synergistically with clinicians - Dry Eye Disease (DED) is still an area where patients are treated with conventional therapies delivering quite limited practical results. If we consider that 1 of 3 people over the age of 65 is diagnosed with dry eye disease [1], and that the population in the UK amounts to about 66 million people where 18% are over the age of 65, we can consider that approximately 11,880,000 patients in the UK alone are still waiting for the newest dry eye panacea. In addition, in the United States of America, dry eye disease currently affects 17% of the total population with 15 to 33% being over the age of 65 [2].

The numbers are out there to be savoured and analysed, and that is what the members of the TFOS DEWS Management Therapy Subcommittee have been doing with the publication of their Management and Therapy Report. This is a much focused insightful disease state publication emerging after their interactive workshops on DED and their expert conferences on Tear Film and Ocular Surface (TFOS). Their latest publication [3] inform us of how unaddressed, despite so many peculiar innovations and niche approaches, this medical issue is. Nevertheless, countless solutions are being developed, although overshadowed by a major limitation, i.e., no product has yet fully responded to the multiplicity of comorbidities DED revels on.

Products developed to tackle DED are usually linked to treatments for tear insufficiency, for lid abnormalities, anti-inflammatory therapies, surgical approaches and even dietary/environmental considerations. It still remains impossible to find one single product that is effectively producing the desired ‘holistic’ results. Over-the-counter tear replacement products with ocular lubricants are purely palliative, hence populating pharmacies out there without resolving the primary pathophysiology of DED. Use of punctal occlusion therapies developed to temporarily or permanently retain tears on the ocular surface by stalling their drainage, is controversial, as it is linked to promotion of inflammation by prolonging the retention of pro-inflammatory cytokines [4] [5]. Several tear stimulation pharmacologic agents are commercially available or still under pipeline development, but these only usually address stimulation of aqueous, mucin and/or lipid secretion whilst ignoring the underlying issues related to meibomian and lacrimal gland disorders.  Treatments for lid abnormalities have long existed and actually a simple lid hygiene routine can help avoid the occurrence of a variety of lid conditions that trigger DED (e.g., blepharitis – inflammation of the edges of the eyelids). In this case, no pharmaceutical product is as effective as lid scrubs soaked in a mild dilution of baby shampoo applied with  a cotton bud/swab to inhibit upsurge of associated lipolytic bacteria [6] [7] [8] [9]. And finally, anti-inflammatory products like topical glucocorticoids, known to be highly effective in halting immune response cycles, also live up to their infamous reputation of hypertension/cataracts/opportunistic infection developers, if used for a long time [10].

The miracle agent may unexpectedly reside in a coadjuvant biological matrix that has been recently applied to ocular surface disease. This matrix has been used as a contact lens-based device emerging from a birth discarded bioproduct, i.e., amniotic membrane. In fact, two specific products ‘threaten’ to become big names in the Ocular Surface industry (one from the USA and one from the UK) that for the sake of privacy will not be disclosed hereby. These products are delivering revolutionary results even in moderate cases of ocular surface chemical/thermal burns. The revolution is happening, and it is just a matter of time until the industry delivers the one product successfully responding to the multiple comorbidities associated to DED.

Post Photo by Andrew Santellan on Unsplash.

[1] Dry eye syndrome, National Institute for Health and Care Excellence, [https://cks.nice.org.uk/dry-eye-syndrome#!topicSummary], last visited on the 11th of June 2019, last update on August 2017.

[2] Dry Eye Syndrome PPP 2018, American Academy of Ophtalmology, [https://www.aao.org/preferred-practice-pattern/dry-eye-syndrome-ppp-2018], last visited on the 11th of June 2019, last update on November 2018.

[3] Jones, L., Downie, L. E., Korb, D. et al. (2017). "TFOS DEWS II Management and Therapy Report". The Ocular Surface, 15(3), pp. 575-628.

[4] Wang, Y., Dogru, M., Matsumoto, Y., 2007). "The Impact of Nasal Conjunctivochalasis on Tear Functions and Ocular Surface Findings". American Journal of Ophthalmology, 144(6), pp. 930-937.

[5] Erdogan-Poyraz, C., Mocan, M. C., Bozkurt, B. et al (2009). "Elevated Tear Interleukin-6 and Interleukin-8 Levels in Patients With Conjunctivochalasis". Cornea, 28(2), pp. 189-193.

[6] McCulley, J., Dougherty, J. M., Deneau, D. G. (1982). "Classification of Chronic Blepharitis". Ophthalmology, 89(10), pp. 1173-1180.

[7] Geerling, G., Tauber, J., Baudoun, C. et al (2011). "The International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on Management and Treatment of Meibomian Gland Dysfunction". IOVS, 52, pp. 2050-2064.

[8] Romero, J., Biser, S., Perry, H. et al (2004). "Conservative Treatment of Meibomian Gland Dysfunction". Eye & Contact Lens: Science & Clinical Practice, 30(1), pp. 14-19.

[9] Alghamdi, Y. A., Camp, A., Feuer, W., Karp, C. L. et al (2018). "Compliance and subjective patient responses to eyelid hygiene". Eye Contact Lens, 43(4), pp. 213217.

[10] Marsh, P. and Pflugfelder, C. (1999), "Topical nonpreserved methylprednisolone therapy for keratoconjunctivitis sicca in Sjögren syndrome". Ophthalmology, 106(4), pp. 811-816.

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