The Future of Ophthalmic Disease

Oyster Point Pharma is committed to the discovery and development of first-in-class therapies to treat ophthalmic disease.

Leveraging our nicotinic acetylcholine receptor (nAChR) domain expertise, we are focused on leading and supporting the development of OC-01 (varenicline solution) nasal spray for the treatment of the 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.

Oyster Point’s proprietary, investigational Enriched Tear Film (ETF™) Gene Therapy is 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 solution) nasal spray may have the potential to modulate the number 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 solution) nasal spray, administered locally in the nasal cavity, has the potential to treat a wide range of diseases and disorders.

Oyster Point has partnered in a research collaboration to develop unique therapies to potentially treat bacterial infections in ophthalmology using bacteriophages. Bacteriophages, also known as “phages,” are viruses found in the natural environment that infect and replicate, specifically in bacteria. Antibiotics normally kill many bacteria they encounter, although occasionally a few microbes survive, reproduce, and pass on their immunity to future generations. Over time, certain strains of bacteria can become largely or completely impervious to even the strongest antibiotics. Without effective antibiotics, common procedures and operations, including those for ophthalmology, may involve increased risk of infection. As an ocular surface disease company, we are committed to developing treatments for the bacteria-associated diseases of today and of the future.

Pipeline

Compound Therapeutic Route of Administration Preclinical Phase 1 Phase 2 Phase 3 Next Expected Milestone OC-01 OC-101 AAV-NGF OC-103 AAV-X OC-300 Dry EyeDisease Neurotrophic Keratopathy Vernal Kerato-conjunctivitis/Severe Allergic Conjunctivitis Undisclosed Neurotrophic Keratopathy Nasal Spray IntralacrimalGland Injection IntralacrimalGland Injection Nasal Spray FDA Approved(10/15/21) Pre-IND Meeting in 2H 2021 Pre-IND Meeting in 2H 2021 Pre-IND Meeting in 2H 2021 Phase 2 Enrollment in 1H 2021 Small Molecule Enriched Tear Film (ETF™) Gene Therapy Bacteriophage

Pipeline

Small Molecule
OC-01
TherapeuticDry Eye Disease
Route of AdministrationNasal Spray
Phase 3FDA Approved (10/15/21)
TherapeuticNeurotrophic Keratopathy
Route of AdministrationNasal Spray
Phase 1Phase 2 Enrollment in 1H 2021
Enriched Tear Film (ETF™) Gene Therapy
OC-101 AAV-NGF
TherapeuticNeurotrophic Keratopathy
Route of AdministrationIntralacrimal Gland Injection
PreclinicalPre-IND Meeting in 2H 2021
OC-103 AAV-X
TherapeuticVernal Keratoconjunctivitis/Severe Allergic Conjunctivitis
Route of AdministrationIntralacrimal Gland Injection
PreclinicalPre-IND Meeting in 2H 2021
Bacteriophage
OC-300
TherapeuticUndisclosed
PreclinicalPre-IND Meeting in 2H 2021

Small Molecule Programs

Oyster Point has pioneered the administration of selective cholinergic agonist nasal sprays to activate the parasympathetic pathway and stimulate natural tear production, as shown in preclinical and clinical studies. We are focused on the development of OC-01 (varenicline solution) nasal spray for the treatment of the signs and symptoms of dry eye disease, as well as leading and supporting development for 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. We believe that targeting the parasympathetic nervous system through the use of locally administered selective cholinergic agonists, such as OC-01 (varenicline solution) nasal spray, has the potential to treat a wide range of diseases and disorders.

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

Enriched Tear Film (ETF™) Gene Therapy

Adeno-associated virus (AAV) vectors are nonreplicating DNA delivery vehicles that are currently not known to cause disease.

OC-101 (AAV-NGF)
OC-101 (AAV-NGF) is Oyster Point’s investigational gene therapy in development as part of Oyster Point’s proprietary development approach of leveraging 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 sensitivity.1 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.

Bacteriophage (“Phage”) Research Collaboration

Oyster Point has partnered in a research collaboration to develop unique therapies to potentially treat bacterial infections in ophthalmology using bacteriophages. Bacteriophages, also known as “phages,” are viruses that are found in the natural environment that infect and replicate, specifically in bacteria. Interestingly, bacteriophages collectively constitute a majority of organisms found on planet Earth. Bacteriophages are generally safe to humans and are targeted in their ability to infect specific strains of bacteria. Once a bacteriophage attaches to a susceptible bacterium, it causes the host cell to die, releasing new bacteriophage to infect other bacteria, thus increasing the dose at the site of the disease.

Collaborate to Innovate

Oyster Point is driven to research, develop, and commercialize innovative ophthalmic therapies that have the potential to change patients’ lives. We value collaboration with partners who share our mission and have the expertise, curiosity, and ingenuity to reimagine ophthalmic research and development and accelerate the pathway toward delivering for patients.

We have embraced different forms of collaboration, including traditional licensing agreements and research collaborations, and welcome additional opportunities for research, development, and global commercialization that may complement our internal capabilities with the technology, know-how, and experience of exceptional partners.

Interested in collaborating with our team?

Contact: info@oysterpointrx.com

References:
1. Mastropasqua L, Lanzini M, Dua HS, et al (2020). In vivo evaluation of corneal nerves and epithelial healing after treatment with recombinant nerve growth factor for neurotrophic keratopathy. Am J Opthalmol. 217, 278-286.

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