OTX-CSI (cyclosporine intracanalicular insert)

SUSTAINED-RELEASE PRODUCT CANDIDATE FOR DRY EYE DISEASE

OTX-CSI is a long-acting, preservative-free cyclosporine intracanalicular insert being evaluated for the treatment of dry eye disease.1

EXISTING TREATMENTS

  • Slow onset of action for therapy2,3
  • High level of burning and stinging upon administration2,4
  • Burden of patient administration2,4

PRODUCT CANDIDATE ATTRIBUTES

  • Cyclosporine loaded in hydrogel
  • Preservative-free
  • Designed to deliver therapy up to 12 weeks with a single insert
  • Occludes the punctum
  • Fully biodegradable insert

Caution: NEW DRUG – OTX-CSI is currently undergoing clinical evaluation and is limited by law to investigational use only. This product has not been approved by the FDA as safe or effective.

Intracanalicular insertion of OTX-CSI

“Using our novel intracanalicular insert allows for preservative-free delivery of a consistent dose of cyclosporine that potentially makes OTX-CSI both less irritating to the ocular surface and faster acting than current standard of care drop therapies.”

– Michael Goldstein, MD, President, Ophthalmology and Chief Medical Officer

About Chronic Dry Eye Disease

Dry eye disease is a common condition with a global prevalence between 5.3% and 34%5 and totaling more than 16 million Americans.6 It is a chronic inflammatory disease that can be initiated by numerous extrinsic or intrinsic factors that lead to an unstable and hyperosmolar tear film.7,8 Known risk factors include aging, female gender, refractive surgery and autoimmune disease.8 According to the International Dry Eye Workshop, dry eye disease is defined as “a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.”7 A primary mechanism responsible for dry eye is tear hyperosmolarity leading to tissue damage.7 Eye pain is caused by tear hyperosmolarity and loss of lubrication.7 Visual changes are due to tear and ocular surface abnormalities.7 Depending on severity, dry eye disease can limit daily activities such as using a computer, reading, driving9 and also adversely affect sleep10 and work productivity.11

OTX-CSI Insert resides in the canaliculus and occludes the punctum (image)

OTX-CSI Insert resides in the canaliculus and occludes the punctum

Hydrated OTX-CSI insert (image)

Hydrated OTX-CSI insert

REFERENCES: 1. Vanslette A. Presented at the ARVO Annual Meeting; May 3-7, 2020; Baltimore, MD. 2. White DE et al. Clin Ophthalmol. 2020;14:875-883. 3. Trattler W et al. Clin Ther. 2006;28(11):1848-1856. 4. RESTASIS (cyclosporine ophthalmic emulsion) 0.05% [prescribing information]. Irvine, CA: Allergan, Inc.; 2012. 5. Messmer EM. Dtsch Arztebl Int. 2015;112:71-81. 6. Farrand KF et al. Am J Ophthalmol. 2017;182:90-98. 7. Bron AJ et al. Ocul Surf. 2017;15:438-510. 8. Stapleton F et al. Ocul Surf. 2017;15:334-365. 9. Walker PM et al. Cornea. 2010;29(6):607-612. 10. Kawashima M et al. Clin Ophthalmol. 2016;10:1015-1021. 11. Yamada M et al. Clinicoecon Outcomes Res. 2012;4:307-312.