The Future of Ophthalmic Disease

Oyster Point Pharma’s product pipeline reflects our commitment to the discovery, development, and commercialization of first-in-class therapies to treat ophthalmic disease.

Oyster Point’s first commercial product, which leverages our nicotinic acetylcholine receptor (nAChR) domain expertise, was approved in 2021, and we are exploring other potential applications for OC-01 (varenicline solution) nasal spray, including neurotrophic keratopathy, dry eye associated with contact lens intolerance, and ocular surface preparation for refractive surgeries.

In addition, Oyster Point’s proprietary, investigational Enriched Tear Film (ETF™) Gene Therapy platform is in development for the treatment of select ocular surface diseases. Oyster Point Pharma’s investigational ETF™ Gene Therapy approach has been shown in preclinical models to deliver target genes to cells using adeno-associated virus (AAV) vectors, non-replicating DNA delivery vehicles that are 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, peptides, and enzymes 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 a number of selected proteins, peptides, antibodies, hormones, enzymes, or cytokines secreted from the lacrimal gland into the tear film and onto the ocular surface.

Oyster Point has also partnered in a research collaboration to develop unique therapies to 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.

Pipeline

Tyrvaya ® (varenicline solution) Nasal Spray OC-01(varenicline solution)nasal spray NeurotrophicKeratopathyStage 1 OC-101 AAV-NGF OC-103 AAV-DAO Intralacrimal Gland Injection Intralacrimal Gland Injection NeurotrophicKeratopathyStage 2 and 3 Vernal Keratocon- junctivitis/ Atopic Keratocon- junctivitis Dry EyeDisease FDA Approved(October 15, 2021) Phase 2- Results Expected 1Q 2023 Pre-IND Complete Initiating IND-Enabling Studies Pre-IND Complete Initiating IND-Enabling Studies DevelopmentPhase Phase 3 Phase 2 Phase 1 Preclinical Route ofAdministration Indication Product Small Molecule Programs Nasal Spray Nasal Spray Enriched Tear Film (ETF™) Gene Therapy Approach

Pipeline

Small Molecule
TyrvayaTM(varenicline solution) Nasal Spray
TherapeuticDry Eye Disease
Route of AdministrationNasal Spray
Phase 3FDA Approved (10/15/21)
OC-01(varenicline solution) nasal spray
TherapeuticNeurotrophic Keratopathy
Route of AdministrationNasal Spray
Phase 3Phase 2- Results Expected 1Q 2023
Enriched Tear Film (ETF™) Gene Therapy
OC-101 AAV-NGF
TherapeuticNeurotrophic Keratopathy
Route of AdministrationIntralacrimal Gland Injection
PreclinicalPRE-IND Complete Initiating IND-Enabling Studies
OC-103 AAV-DAO
TherapeuticVernal Keratoconjunctivitis/Atopic Keratoconjunctivitis
Route of AdministrationIntralacrimal Gland Injection
PreclinicalPRE-IND Complete Initiating IND-Enabling Studies

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.

Oyster Point’s first commercial product, which leverages our nicotinic acetylcholine receptor (nAChR) domain expertise, was approved in 2021, and we are exploring other potential applications for OC-01 (varenicline solution) nasal spray, including neurotrophic keratopathy, dry eye associated with contact lens intolerance, and ocular surface preparation for refractive surgeries.

Clinical and development stage programs for OC-01 (varenicline solution) nasal spray have not been approved for use. Further, the safety and efficacy of OC-01 (varenicline solution) nasal spray have not been established in our clinical and development stage programs.

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 gene that encodes nerve growth factor (NGF). 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) has not been established.

OC-103 (AAV-DAO)

OC-103 (AAV-DAO) is an AAV containing the gene that encodes human diamine oxidase (DAO). DAO is a naturally occurring human enzyme responsible for breaking down excess histamine, a compound that has been shown to induce various physiological and immunological changes through histamine receptor stimulation on the ocular surface2,3. By administering OC-103 (AAV-DAO) into the lacrimal gland, our goal is to harness the body’s protein-producing machinery to produce DAO, which would then secrete this naturally present enzyme into the tear film and onto the ocular surface.

OC-101, OC-103 (AAV-DAO) are investigational gene therapies that have not been tested in humans and has not been approved for any use in any country.

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.
2. Abelson, M. B., Leonardi, A. A., Smith, L. M., Fregona, I. A., George, M. A., & Secchi, A. G. (1995). Histaminase activity in patients with vernal keratoconjunctivitis. Ophthalmology, 102(12), 1958-1963.
3. Azari, A. A., & Arabi, A. (2020). Conjunctivitis: a systematic review. Journal of ophthalmic & vision research, 15(3), 372

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