Small biotech Oyster Point sets up pitch to disrupt dry eye market with nasal spray
Oyster Point Pharma — a small Princeton, NJ-based biotech looking to disrupt a massive eye drug market largely monopolized by two therapies — has positive pivotal trial data as it marches on a path towards US approval.
Oyster, which went public in an $80 million IPO last year, has a nasal formulation of varenicline —a formulation of Pfizer’s smoking-cessation drug Chantix — it is developing for dry eye disease, a chronic, episodic disease affecting the tears and ocular surface that affects some 33 million Americans.
The condition currently represents a global market of more than $5 billion and is expected to grow to about $8 billion by 2025, according to Needham analysts. The therapeutic market is dominated by anti-inflammatory eye drops: Allergan’s Restasis — although generic competition is eating into sales as AbbVie buys the large drugmaker — and Shire’s Xiidra (purchased last year by Novartis in a $5.3 billion deal), as well as over-the-counter artificial tears.
Two doses of Oyster’s formulation, called OC-01, (0.6 mg/ml and 1.2 mg/ml) were tested against a placebo in 758 patients with mild, moderate, and severe dry eye disease in the ONSET-2 study.
Both doses met the main goal of the study — a statistically significant improvement in subjects gaining > 10 mm in Schirmer’s score (a test designed to assess a person’s eyes make enough tears to keep the eyes moist) at week 4, versus the control arm. In the smaller dose group, the percentage of patients hitting that score was 44%, and on the higher group the percentage of patients hitting the goal was 47% — in the control group, the percentage was 26%.
In addition, in the smaller dose group, the mean change in Schirmer’s score was 11.0 mm. In the higher dose group the mean change in score was 11.2 mm — in the control group, the change was 5.9 mm. Key secondary goals, including an improvement in eye dryness, were also met. The most common side effect, experienced by half the patients, was sneezing.
The existing crop of drugs such as Xiidra and Restasis can take weeks or months to take effect. Eye consultants indicate that Restasis and Xiidra have failure rates of 50%+ and tolerability issues which further limit their use, and neither product is completely effective for all patients, Cowen’s Ken Cacciatore wrote in a note in late March, estimating OC-01 represents a $1 billion-plus opportunity given the need for new treatment alternatives.
The ONSET-2 study adds to mixed but largely positive mid-stage trial data on OC-01 — and Oyster is prepping to submit a marketing application in the second quarter.
“The ability to show statistically significant sign and symptom endpoints within the same clinical trial has been elusive in dry eye disease,” said company chief Jeffrey Nau in a statement. “The ability to meet this high bar in the ONSET-2 population consisting of mild, moderate, and severe subjects is even more notable and speaks to the broad applicability of OC-01 to treat dry eye patients.”
For example, mixed trial results prompted the FDA to ask for additional efficacy data on Xiidra, which were eventually supplied. Only then did the agency sanction approval in 2016.
Another potential dry eye disease drug, Kala Pharmaceuticals’ Eysuvis, which is being developed for acute use, also had a mixed dataset, which prompted a rejection last August. In March, the company — one of the plethora of biotechs that trace their roots to the prolific lab at MIT led by Bob Langer — posted data from another late-stage study as it looks to resubmit its marketing application.