Oyster Point Submits NDA to FDA for OC-01 Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease
Oyster Point Pharma announced it has submitted a 505(b)(2) new drug application (NDA) to the FDA for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The NDA submission is supported by safety and efficacy results from the phase 3 ONSET-2, phase 2b ONSET-1, and phase 2 MYSTIC clinical trials in over 1,000 subjects with dry eye disease.
The MYSTIC, ONSET-1 and ONSET-2 clinical trials showed statistically significant improvements in Schirmer’s Score as compared to control, which was the primary endpoint in all studies. Key secondary endpoints in ONSET-1 and ONSET-2 included change from baseline in symptoms as assessed by eye dryness score. In both of these pivotal studies, there was statistically or nominally statistically significant improvement in symptom scores at Day 28, and in ONSET-2 as early as Day 14, as compared to control. All doses studied in the clinical trial program were well-tolerated with no serious drug related adverse events.
“The submission of Oyster Point’s first NDA is a major step towards our goal of bringing novel and transformative therapies to patients with ocular surface diseases,” Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point Pharma, said in a company news release. “We have intently focused on the advancement of OC-01 nasal spray from formulation through clinical development and regulatory submission over the last three years. We look forward to continued interaction with the FDA during the review process.”
“We are excited by the potential of OC-01 nasal spray, if approved, becoming a meaningful addition to the eye care practitioner’s treatment armamentarium, and the potential to create a paradigm shift in how practitioners and their patients treat dry eye disease,” stated Marian Macsai, MD, chief medical officer of Oyster Point Pharma.
About ONSET-1, ONSET-2, and MYSTIC
The ONSET-1 Phase 2b and the ONSET-2 phase 3 pivotal clinical studies were each multicenter, randomized, double-masked, vehicle-controlled trials in adult subjects with dry eye disease in the U.S. The main eligibility criteria for both studies included a physician’s diagnosis of dry eye disease, a baseline Schirmer’s Score of £ 10 mm, and symptom criteria of an eye dryness score from 0-100 (VAS scale). OC-01 nasal spray was administered as a single spray into each nostril twice-daily, and the primary and key secondary endpoints, including improvement in Schirmer’s Score and eye dryness score, as compared to control, were measured at Day 28. ONSET-1 and ONSET-2 studies of OC-01 nasal spray enrolled a broad population of mild, moderate, and severe subjects. The MYSTIC phase 2 clinical trial was a single-center, randomized, double-masked, vehicle-controlled trial in adult subjects with dry eye disease in Mexico. The MYSTIC trial evaluated Schirmer’s Score of enrolled subjects after 84 days of twice-daily administration of OC-01 nasal spray, as compared to control.
About OC-01 Nasal Spray
OC-01 is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease. The parasympathetic nervous system, the “rest and digest” system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. Administered as a preservative-free, aqueous nasal spray, in pre-clinical and clinical studies, OC-01 (varenicline) nasal spray was shown to have a novel mechanism of action with activation of the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural 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. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any indication in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not previously been established.