The NDA submission is based on efficacy and safety results from a comprehensive clinical trial program conducted in patients with a broad range of dry eye disease.
PRINCETON, NJ, USA I December 18, 2020 I Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced it has submitted a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (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 (an objective, reproducible, and quantifiable measure of natural tear film production), 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,” said Jeffrey Nau, Ph.D., M.M.S., president and CEO of Oyster Point Pharma. “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, M.D., 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.
About Dry Eye Disease
Dry eye disease is a chronic, progressive condition that impacts more than 30 million people in the United States and is growing in prevalence. An estimated 16 million adults in the U.S. have been diagnosed with dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film. A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye disease can have a significant impact on a person’s day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.
About Oyster Point Pharma, Inc.
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Oyster Point Pharma’s lead product candidate, OC-01 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. In pre-clinical and clinical studies, OC-01 nasal spray was shown to have a novel mechanism of action via activation of the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit.
SOURCE: Oyster Point Pharma
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The NDA submission is based on efficacy and safety results from a comprehensive clinical trial program conducted in patients with a broad range of dry eye disease.
PRINCETON, NJ, USA I December 18, 2020 I Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced it has submitted a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (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 (an objective, reproducible, and quantifiable measure of natural tear film production), 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,” said Jeffrey Nau, Ph.D., M.M.S., president and CEO of Oyster Point Pharma. “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, M.D., 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.
About Dry Eye Disease
Dry eye disease is a chronic, progressive condition that impacts more than 30 million people in the United States and is growing in prevalence. An estimated 16 million adults in the U.S. have been diagnosed with dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film. A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye disease can have a significant impact on a person’s day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.
About Oyster Point Pharma, Inc.
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Oyster Point Pharma’s lead product candidate, OC-01 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. In pre-clinical and clinical studies, OC-01 nasal spray was shown to have a novel mechanism of action via activation of the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit.
SOURCE: Oyster Point Pharma
Post Views: 20
