Ocular Surface Diseases and Beyond

Oyster Point Pharma is committed to the discovery and development of first-in-class therapies to treat diseases of the ocular surface.

Leveraging our nicotinic acetylcholine receptor (nAChR) domain expertise, we are focused on the development of OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease, as well as a number of potential indications and uses associated with and beyond dry eye disease. These include neurotrophic keratopathy, dry eye associated with contact lens intolerance and ocular surface preparation for refractive surgeries.

OC-01 (varenicline) nasal spray is also an integral part of our proprietary, investigational Enriched Tear Film (ETF™) Gene Therapy in development for the treatment of select ocular surface diseases. Oyster Point Pharma’s investigational ETF™ Gene Therapy has been shown in preclinical models to deliver target genes to cells using adeno-associated virus (AAV) vectors, nonreplicating DNA delivery vehicles that are currently not known to cause disease. In preclinical models, it has been shown that the protein-producing machinery in the lacrimal gland can be harnessed to secrete selected proteins in the body’s own natural tear film to potentially treat diseases of the ocular surface. We believe that this approach has the potential to change the way that chronic diseases of the ocular surface are treated. Additionally, in preclinical models, it has been shown that OC-01 (varenicline) nasal spray may have the potential to modulate the amount of selected proteins, peptides, antibodies, hormones, enzymes or cytokines secreted from the lacrimal gland into the tear film and onto the ocular surface. We believe that targeting the parasympathetic nervous system through the use of cholinergic agonists, such as OC-01 (varenicline) nasal spray, administered locally in the nasal cavity has the potential to treat a wide range of diseases and disorders.

Our lead candidate, OC-01 (varenicline) nasal spray, is being developed for the Treatment of Signs and Symptoms of Dry Eye Disease
Oyster Point is pioneering a novel approach to treating ocular surface diseases with Enriched Tear Film (ETF) Gene Therapy
OysterPoint Pipeline
The safety and efficacy of our investigational drugs and gene therapy have not been established. These investigational products have not been approved by the U.S. Food and Drug Administration or other regulatory authorities.

Oyster Point has pioneered the administration of selective cholinergic agonist nasal sprays to activate the parasympathetic pathway and stimulate natural tear production, as show in pre-clinical and clinical studies. We are focused on the development of OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of Dry Eye Disease, as well as a number of potential indications and uses associated with and beyond dry eye disease. These include neurotrophic keratopathy (NK), dry eye associated with contact lens intolerance, and ocular surface preparation for refractive surgeries. We believe that targeting the parasympathetic nervous system through the use of locally administered selective cholinergic agonists, such as OC-01 (varenicline) nasal spray, has the potential to treat a wide range of diseases and disorders.

OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal have not been established.

Adeno-associated virus (AAV) vectors are nonreplicating DNA delivery vehicles that are currently not known to cause disease. OC-101 (AAV-NGF) is Oyster Point’s investigational gene therapy in development as part of Oyster Point’s proprietary development approach of leveraging Enriched Tear Film (ETF™) Gene Therapy to treat select ocular surface diseases. OC-101 is an AAV containing the nerve growth factor (NGF) gene. NGF is a naturally occurring protein secreted by cells on the surface of the cornea and involved in the differentiation and maintenance of neurons that has been shown to heal the corneal epithelium and improve corneal sensitivity1. Once administered to the lacrimal gland, OC-101 (AAV-NGF) has been shown in preclinical studies to harness the body’s protein-producing machinery to produce NGF, which was then secreted into the tear film and onto the ocular surface.

OC-101 (AAV-NGF) is an investigational gene therapy that has not been tested in humans and has not been approved for any use in any country. The safety and efficacy of OC-101 (AAV-NGF) have not been established.

Our lead candidate, OC-01 Nasal Spray, is being developed for Treatment of the Signs and Symptoms of Dry Eye Disease
Oyster Point is pioneering a novel approach to treating ocular surface diseases with Enriched Tear Film (ETF) Gene Therapy.

OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not been established.

OC-101 (AAV-NGF) is an investigational gene therapy that has not been tested in humans and has not been approved for any use in any country. The safety and efficacy of OC-101 (AAV-NGF) have not been established.

Reference
1 Mastropasqua, L., Lanzini, M., Dua, H. S., D’Uffizi, A., Di Nicola, M., Calienno, R., … & Nubile, M. (2020). In vivo evaluation of corneal nerves and epithelial healing after treatment with recombinant nerve growth factor for neurotrophic keratopathy. American journal of ophthalmology, 217, 278-286.