The company’s two lead product candidates are OC-01 and OC-02, which are delivered by way of an ocular surface-sparing nasal spray that stimulates the trigeminal parasympathetic pathway to induce natural tear film production.
Princeton, NJ-based Oyster Point Pharma closed on a Series B round worth $93 million. It was co-led by Invus Opportunities and Flying L Partners in collaboration with& Falcon Vision. Existing investors New Enterprise Associates (NEA)and Versant Ventures participated, as well as new investor Vida Ventures.
The company plans to use the funds raised to support its development of its portfolio for dry eye diseases, as well as new treatment areas, and to hire new people. The company’s two lead product candidates are OC-01 and OC-02, which are delivered by way of an ocular surface-sparing nasal spray that stimulates the trigeminal parasympathetic pathway to induce natural tear film production.
On July 12, 2018, the company announced results from its PEARL Phase IIb clinical trial of OC-02 for Dry Eye Disease (DED). It was a dose-ranging, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of the drug in 165 patients in the U.S.
The primary endpoints were the assessment of tear production by way of a test measuring Schirmer’s score, and by patient-reported symptoms measured by the validated Eye Dryness Scale (EDS).
At the time, company chief executive officer Jeffrey Nau stated, “We are excited by the results of the PEARL study. Showing a statistically significant improvement in both the signs and symptoms of dry eye within the same clinical trial validates the potential of stimulating the trigeminal parasympathetic pathway with this class of compound to increase natural tear film production.”
He went on to say, “These results indicate a clear dose-response to OC-02 and suggest that this novel approach can stimulate tear production in dry eye patients with a broad range of baseline severity. We look forward to the continued development of both of our compounds, OC-02 and OC-01.”
Of the investment, Benjamin Tsai of Invus, noted, “Our team sees immense promise in this investment given Oyster Point’s encouraging clinical evidence, the potential market size, and the leadership team’s extensive experience developing and commercializing ophthalmology therapies. We believe Oyster Point’s therapies will redefine the standard of care for Dry Eye Disease, a condition that affects millions of people.”
Sales for Dry Eye Syndrome products in 2016 were estimated to be about $2.2 billion. A research report by Transparency Market Research projects the 2026 market to be about $7.7 billion.
In August 2018, Sun Pharmaceuticals entered the market when its dry eye treatment Cequa (cyclosporine ophthalmic solution) was approved by the U.S. Food and Drug Administration.
Dry eye disease, or keratoconjunctivitis sicca, affects about 16 million people in the U.S. It’s a market with a number of major players, such as Allergan’s Restasis and Shire’s Xiidra. Others working in the areas include Mylan and Kala Pharmaceuticals. However, Restasis is starting to lose patent protection.
Dry eye disease is a multifactorial condition and defies a “one-drug-meets-all” response. It is marked by the loss of tear film homeostasis. Healthy tear film protects and lubricates the eyes, helps wash away foreign matter, and contains antimicrobials that reduces the risk of infection. Dry Eye Disease causes a sensation of dryness, stinging, scratching, burning sensations, as well as light sensitivity, blurred vision, and eye fatigue.
