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Dry eye

Lacrimal gland dysfunction is a major cause of dry eye disease
The era of antiaging ophthalmology comes of age: antiaging approach for dry eye treatment.
Tsubota K; Kawashima M; Inaba T; Dogru M; Ogawa Y; Nakamura S; Shinmura K; Higuchi A; Kawakita T.
Ophthalmic Research. 44(3):146-54, 2010.
Aging and dry eye disease.
Ding J; Sullivan DA.
Experimental Gerontology. 47:483, 2012.
The antiaging approach for the treatment of dry eye.
Tsubota K et al;
Cornea. 31: Suppl 1:S3, 2012.
Currently, there is no therapy available to recover lacrimal function to its normal status.
Meibomian Gland Disease: The Role of Gland Dysfunction in Dry Eye Disease. 
Chhadva P; Goldhardt R; Galor A.
Ophthalmology. 124 (11S):S20-S26, 2017.
Age-dependent changes in rat lacrimal gland anti-oxidant and vesicular related protein expression profiles.
Batista TM et al.,
Molecular Vision. 18:194-202, 2012.
Emerging strategies for the diagnosis and treatment of meibomian gland dysfunction.
G. Geerling et al.
The Ocular Surface 15: 179e192, 2017
Advances in Functional Restoration of the Lacrimal Glands
Masatoshi Hirayama
IOVS, Special Issue. Vol. 59, No.14, DES175, 2018
Regeneration of Lacrimal Gland Function to Maintain the Health of the Ocular Surface
Tetsuya Kawakita
IOVS, Special Issue. Vol. 59, No. 14, DES170, 2018
Meibomian Gland Dysfunction: Recent Progress Worldwide and in Japan
IOVS, Special Issue. Vol. 59, No. 14, DES88, 2018
Meibomian gland dysfunction is the primary determinant of dry eye symptoms: Analysis of 2346 patients
The Ocular Surface 18: 604–612, 2020
Advantage of AH-201-DE :
Dry eye is an aging process of lacrimal gland of eye which is well recognized recently.
AH-201-DE is the first small molecule through antiaging approach for dry eye drug discovery.
AH-201-DE is an endogenous EPO inducer for activating mitochondria biogenesis and hemoglobin production in lacrimal gland.
So far, no effective therapy for dry eye, AH-201-DE can expand the global market for dry eye.
We are on-going the pre-IND meeting to TFDA.
Global market for dry eye
Transparency Market Research(2018,Jan)
estimates that the dry eye disease market will expand at a CAGR of 4.5% over the forecast period between 2017 and 2025. Escalating at this pace, the market, which had a valuation of US$ 5 billion in 2016 in terms of revenue, is projected to rise to US$ 7,780.0 Mn by 2025.
Ophthalmic Res 44:146, 2010
The Era of Antiaging Ophthalmology Comes of Age: Antiaging Approach for Dry Eye Treatment.
MedEdicus Proceeding from a CME symposium during AAO 2015
Addressing Unmet Needs in Dry Eye Disease.
THE Ocular Surface 14:264, 2016
Targeting the Unmet Need for Dry Eye Treatment
Antiaging approach for dry eye had been highlighted as “comes of age”,
EH-201 is the unique one for recovery the tear gland dysfuction,
instead of current eye drugs most belong to inhibit on dry eye induced inflammation approach.
Age-related alterations in the lacrimal gland of adult albino rat: a light and electron microscopic study.
El-Fadaly AB, El-Shaarawy EA, Rizk AA, Nasralla MM, Shuaib DM
Annals of Anatomy. 196(5):336-51, 2014.
The Effects of Aging on Corneal and Ocular Surface Homeostasis in Mice.
De Silva MEH, Hill LJ, Downie LE, Chinnery HR
Investigative Ophthalmology & Visual Science. 60(7):2705-2715, 2019
Comparative Analysis of Age-Related Changes in Lacrimal Glands and Meibomian Glands of a C57BL/6 Male Mouse Model.
Yoon CH, Ryu JS, Hwang HS, Kim MK
International Journal of Molecular Sciences. 21(11), 2020
Takeda is offloading dry-eye drug Xiidra to Novartis for up to $5.3 billion, including upfront cash $3.4 billion and milestone based follow-up payments in 2019. Novartis gives up on Xiidra‘s EU approval in 2020 June after EMA regulators there raised “major objections” that ” Specifically, the agency concluded that Xiidra hadn't proven effective across different symptoms of dry eye disease. the improvement was not considered clinically significant,”.
Xiidra (Lifitegrast) inhibits an integrin, LFA-1), from binding to ICAM-1. This mechanism down-regulates inflammation mediated by T lymphocytes.
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