We’re focused on therapies for the ocular surface beginning with dry eye disease

Dry eye disease (DED) is a multifactorial chronic disease of the ocular surface characterized by a loss of homeostasis of the tear film, resulting in pain, visual impairment, tear film hyperosmolarity and instability, inflammation and corneal wounding.1 More than 340 million adults globally and approximately 34 million adults in the United States are estimated to suffer from DED.2,3

Patients with DED are also more susceptible to eye infections and damage to the surface of the eye (cornea). DED is characterized by a reduction in tear volume, rapid breakup of the tear film, and/or an increase in the evaporative properties of the tear film layer. Chronic symptoms of DED include a scratchy sensation (foreign body sensation), stinging or burning, episodes of excess tearing that follow periods of dryness, discharge, pain, and redness in the eye. In addition, patients with dry eye disease often experience blurred vision as the cornea and the tear film are responsible for 65% to 75% of the eye’s focusing power. DED affects daily life, including reading and driving at night, and has been associated with depression and migraines. Underlying DED can limit patients’ ability to tolerate contact lenses and impacts patient satisfaction with post-op cataract and refractive patients. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.

Normal Tear Film Production

Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film is responsible for forming the primary refracting surface of the cornea, as well as protecting and moisturizing the cornea.

The National Eye Institute defines healthy tear film as “a complex mixture of fatty oils, water, mucus, and more than 1,500 different proteins that keep the surface of the eye smooth and protected from the environment, irritants, and infectious pathogens.”

The Lacrimal Functional Unit (LFU), which is controlled by the parasympathetic nervous system, is comprised of meibomian glands, lacrimal glands, and goblet cells that are responsible for producing the layers that comprise healthy tear film. The outermost layer of tear film is a lipid layer produced by the meibomian glands that keeps tear film from evaporating too quickly. The lacrimal glands produce the aqueous layer, which comprises the bulk of tear volume and flow. This layer is not just water – it contains thousands of proteins, enzymes, antibodies and growth factors that are cytoprotective, anti-inflammatory, and anti-microbial. The aqueous layer nourishes the cornea and the conjunctiva, the mucous membrane that covers the entire front of the eye and the inside of the eyelids. Finally, the innermost mucin layer is produced by goblet cells and binds water from the aqueous layer to ensure that the eye remains wet. The LFU receives stimulus from the trigeminal nerve, which has sensory nerve endings in the nasal cavity.

LFU

Lacrimal Functional Unit (LFU) Dysfunction

LFU dysfunction leads to the loss of tear film homeostasis and can ultimately lead to the cycle of chronic DED. Disruption and instability of the tear film results in irritation, inflammation, and ultimately cellular damage.

Lacrimal Functional Unit (LFU) Dysfunction
We believe that there is a significant unmet need for therapies that directly address the loss of tear film homeostasis, the fundamental characteristic of DED. Our lead product candidate OC-01 is designed to stimulate the LFU to produce natural tear film, re-establish tear film homeostasis and improve the signs and symptoms of patients with DED.
OC-01

1Jennifer P. Craig, MCOptom, PhD, Kelly K. Nichols, OD, PhD, Esen K. Akpek, MD, Barbara Caffery, OD, PhD, Harminder S. Dua, MD, PhD, Choun-Ki Joo, MD, PhD, Zuguo Liu, MD, PhD, J. Daniel Nelson, MD, Jason J. Nichols, OD, PhD, Kazuo Tsubota, MD, PhD, Fiona Stapleton, MCOptom, PhD. TFOS DEWS II Definition and Classification Report; / The Ocular Surface 15 (2017) 276-283

2Market Scope 2016 Dry Eye Products Report: A Global Market Analysis for 2015 to 2021

3Paulsen AJ, Cruickshanks KJ, Fischer ME, Huang GH, Klein BE, Klein R, Dalton DS. Dry eye in the beaver dam offspring study: prevalence, risk factors, and health-related quality of life. American Journal of Ophthalmology. 2014 Apr;157(4):799-806.