Message from Product Strategy Planning Office

With the management philosophy of “Good Company” and a company that shapes “Beyond eyesight,” we have developed products that contribute to maintenance and improvement of “a joy to behold” or QOV (Quality of Vision) of patients worldwide. We commercialized senile cataract drugs in 1958, and subsequently, antimicrobial ophthalmic solutions, non-steroidal anti-inflammatory ophthalmic solutions, therapeutic drugs for spring catarrh (orphan drugs), therapeutic drugs for glaucoma, ocular hypertension, etc. We also contributed to reducing the economic burden on patients by using various generic drugs and biosimilars.

In addition, there are various other eye diseases. The World Report on Vision issued by the WHO in 2019 reports that more than 2.2 billion people worldwide developed visual impairment or blindness, and that 1 billion or more of them did not receive the necessary treatment. In addition, cataracts, refractive errors (myopia, presbyopia, etc.), age-related macular degeneration, glaucoma, and diabetic retinopathy have been reported to be the major causes of visual impairment or blindness worldwide.

We will continue our research and development activities with the utmost effort to create high-value products for eye diseases (“First in Class”, “Best in Class”, and with enhanced convenience for patients). We mainly identify "corneal disease," "glaucoma," "retinal disease," and "allergic conjunctivitis" as the diseases we find important in terms of product strategy based on "contribution of the diseases to visual impairment or blindness," "satisfaction of unmet medical needs*," and "possibility of commercialization." We have mainly developed ethical drugs in the past; however, we decided to develop new medical devices based on our desire to contribute to ophthalmological treatment.

In the future development of products, we will elaborate and provide as many high-value products as possible to the world with the power which each of us has as a “Bliss Creator**” and our greatest strength: the power of “the solidarity of the entire company.”

*Unmet medical needs: The medical needs that have not been satisfied yet
**Bliss Creator: A person who sees the purpose and meaning of their work as connected to the "happiness" of all people involved with Senju Pharmaceutical and provides the "joy beyond expectations" to the world by creating new values based on a strong sense of mission and high resolution.

Corneal diseases

Dry eye (DE) is a typical corneal disease. Dry eye causes discomfort and abnormal visual function owing to an unstable tear film, which may damage the ocular surface. Major symptoms of dry eye include dry feeling of the eyes, pain, tiredness, hyperemia, and reduced visual acuity. The use of PC and smartphones called visual display terminals (VDT), wearing contact lenses, and aging are major risk factors for dry eye. Environmental factors, such as air conditioning, are also considered to be associated. Dry eye is also known to be caused by changes in hormone balance, autoimmune diseases, adverse reactions to drugs, etc.#1 It has been reported that 940 million people* are affected worldwide (more than 20 million people in Japan), and this number is expected to increase in the future^{#1, 2, 3, 4}.
Ophthalmic solutions are primarily used to treat dry eye. Drugs that promote the secretion of tear components, such as artificial tears, hyaluronate, and mucin, are used in Japan, whereas drugs such as immunosuppressants to suppress inflammation of the ocular surface are used in the U.S. and EU. We consider that the current treatment issues have an insufficient effect on subjective symptoms, such as dryness, pain, and time required until the effects propagate.
Therefore, we aim to satisfy the unmet medical needs for dry eye worldwide, mainly with next-generation therapeutic drugs that can alleviate subjective symptoms early.
Other than dry eye, corneal diseases include intractable diseases, such as Fuchs’ endothelial corneal dystrophy. The latter condition is rare in Japan and generally known as a rare disease, yet there are many patients suffering from it worldwide and it is known as the most common hereditary corneal diseasesup^#5,6. Currently, no therapeutic drug is available, and corneal transplantation is performed in patients with severe disease progression. We will continue to take on the challenge to develop innovative therapeutic drugs that may lead to patients' hope to avoid or overcome these diseases where there are limited treatment methods.

•  #1:Sachiko Inoue, Motoko Kawashima, Kazuo Tsubota: What is dry eye? From causes to most recent therapy, Farumashia, 2014 50(3): 201-6
•  #2: Papas EB. The global prevalence of dry eye disease: A Bayesian view. Ophthalmic Physiol Opt. 2021;41(6):1254-66
•  #3: United Nations population Fund, state of world population. 2024.
•  #4: Norihiko Yokoi, Hiroaki Kato: Paradigm shift in the dry eye treatment. Stratified diagnosis of ocular surface and stratified treatment. Journal of Kyoto Prefectural University of Medicine, 2013 122(8): 549-57
•  #5: Nakagawa T, Tokuda Y, Nakano M, Komori Y, Hanada N, Tourtas T, et al. RNA-Seq-based transcriptome analysis of corneal endothelial cells derived from patients with Fuchs endothelial corneal dystrophy. Sci Rep. 2023;13(1):8647.
•  #6: Krachmer JH, Purcell JJ Jr, Young CW, Bucher KD. Corneal endothelial dystrophy. A study of 64 families. Arch Ophthalmol. 1978; 96(11):2036-9.

* The number of patients worldwide was estimated from several sources.

Glaucoma

Glaucoma is a disease in which nerve fibers are damaged by numerous factors, such as intraocular pressure, aging, family history, living environment, and the influence of drugs, which gradually cause visual field defects and may result in blindness. It affects 76 million people worldwide (4.65 million people in Japan) and is expected to increase in the future ^{#7, 8}.
The only reliable evidence-based treatment is a decrease of ocular pressure. Treatment options include drug therapy (eye drops), surgical therapy, and laser therapy, which are selected according to the glaucoma classification and progression rate. In recent years, various eye-pressure-lowering drugs with different mechanisms of action have been developed for drug therapy, and treatment options have been increasing. In principle, drug therapy initiates with monotherapy, and if the eye pressure-lowering effect is judged to be insufficient, the drug is changed or added. Problems with drug therapy include the occurrence of side effects when used for a long period and a reduction in adherence (treatment compliance) when combined with multiple drugs because the use is required for a lifetime.
We have been developing therapeutic drugs with efficacy and safety superior to those of existing drugs. We are developing drugs that combine multiple active ingredients and improving the container for eye drops, aiming to reduce the burden of drug management and frequency of application of eye drops for patients, improving adherence, and reducing side effects. While continuing such research and development in the future, we will also conduct research and development of next-generation therapeutic drugs with an innovative approach for patients where decreasing ocular pressure alone is insufficient, and thus, visual field impairment progresses.

•  #7: Japan Glaucoma Society Guidelines for Glaucoma (5th edition)
•  #8: World report on vision. Geneva: World Health Organization; 2019.

Retinal diseases

Typical retinal diseases include age-related macular degeneration (a disease in which the macula, the center of the retina, is damaged), diabetic retinopathy, and diabetic macular edema (a disease in which the retina and macula are damaged due to diabetes), all of which can cause blurring or distortion of the center of vision, resulting in decreased vision. Aging is considered to be one of the factors for the onset of age-related macular degeneration (AMD). The number of patients with AMD is estimated to be as high as 200 million worldwide (700,000 in Japan), and is expected to increase in the future#9,10. Diabetic retinopathy, estimated to affect 537 million people worldwide, is one of three 3 major complications of diabetes mellitus (DM). It has been reported that 93 million diabetic patients worldwide (3 million in Japan) have abnormal fundus findings * and 21 million patients suffer from diabetic macular edema worldwide (650,000 in Japan)^{#11, 12, 13}.
In these diseases, abnormal blood vessels, such as new blood vessels in the choroid membrane and retina, cause bleeding and edema. In recent drug therapies, intravitreal injection of antibody drugs targeting the vascular endothelial growth factor (VEGF) protein, which increases angiogenesis and leakage of blood components from blood vessels, has become mainstream. Current treatment issues are considered a large economic burden on patients because of the very high cost of drugs and the large physical and mental burden on patients for eye injection.
To solve these problems, we first developed drugs (biosimilars) that have equivalent/homogenous quality, safety, and efficacy to existing antibody drugs and contribute to reducing the economic burden on patients and medical expenses. We are working on the research and development of therapeutic drugs that do not require injections or reduce the frequency of injections, as well as on the discovery of the world’s first drug with a new treatment concept.

•  #9: Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-16.
•  #10: Miho Yasuda Observational study (cohort study) Hisayama-machi study. Journal of the Eye. 2009; 6(1): 25-30
• #11: Welcome to IDF | International Diabetes Federation.
• #12: Clinical Practice Guidelines for Diabetic Retinopathy (1st Edition)
• #13: Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, et al. Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35(3):556-64.

* The number of patients in Japan was estimated from literature #11-13.

Allergic conjunctivitis

Allergic conjunctivitis is a disease that causes inflammation of the conjunctiva due to the release of histamine in response to allergens, such as pollen, mites, and pet hair. The main symptoms of allergic conjunctivitis include itching, conjunctival hyperemia, conjunctival edema, and lacrimation. In severe cases, corneal epithelial cells are damaged, which may affect visual acuity.
It has been reported that 500-2400 million people* are affected worldwide (approximately 18-25 million in Japan)^{#3, 14, 15, 16} , and this number is expected to increase in the future^#17.
Antihistamine eye drops, which block histamine receptors and suppress the physiological activity of histamine, are used worldwide for the treatment of allergic conjunctivitis. Current treatment issues include the high frequency of instillation and the insufficient effects in a certain percentage of patients.
We have contributed to the treatment of patients with allergic conjunctivitis by licensing antihistamine ophthalmic solutions to a pharmaceutical company in the U.S. In the future, we will proceed with the research and development of therapeutic drugs that will provide superior efficacy and safety with less frequent instillation, as well as innovative therapeutic drugs that have a new mechanism of action with superior efficacy.

• #14: "Population Estimates" (Statistics Bureau, Ministry of Internal Affairs and Communications)
• #15: Guidelines for Allergic Conjunctival Diseases (Version 3)
• #16: Alqurashi KA, Bamahfouz AY, Almasoudi BM. Prevalence and causative agents of allergic conjunctivitis and its determinants in adult citizens of Western Saudi Arabia: A survey. Oman J Ophthalmol. 2020;13(1):29-33.
• #17: Miyazaki D, Fukagawa K, Okamoto S, Fukushima A, Uchio E, Ebihara N, et al. Epidemiological aspects of allergic conjunctivitis. Allergol Int. 2020;69(4):487-95.

* The number of patients was estimated from literature #3 and #14-16.