OTX-CSI (cyclosporine intracanalicular insert)

SUSTAINED RELEASE THERAPY FOR DRY EYE DISEASE

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

ISSUES WITH EXISTING TREATMENTS

  • Slow onset of action for therapy1,2
  • High level of burning, stinging and irritation upon administration1,2
  • Burden of patient administration1,2

KEY PRODUCT ATTRIBUTES

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

Expect topline data from Phase 2 trial 1H 2022

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, President, Ophthalmology and CMO – 9/29/2020

About Chronic Dry Eye Disease

Dry eye disease is a common condition with a global prevalence between 5.3% and 34%3 and totaling more than 16 million Americans.4 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.5 Known risk factors include aging, female gender, refractive surgery, autoimmune disease and smoking.6 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”.5 A primary mechanism responsible for dry eye is tear hyperosmolarity leading to tissue damage.5 Eye pain is caused by tear hyperosmolarity and loss of lubrication.5 Visual changes are due to tear and ocular surface abnormalities.5 Depending on severity, dry eye disease can limit daily activities such as using a computer, reading, driving7 and also adversely affect sleep8 and work productivity.9 Although there are several drug therapies and procedures for treating dry eye disease, there remains an unmet need for providing long-term management of disease for most dry eye patients.

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. Restasis Label https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050790s020lbl.pdf 2. White DE, Zhao Y, Jayapalan H, Machiraju P, Periyasamy R, Ogundele A. Treatment Satisfaction Among Patients Using Anti-Inflammatory Topical Medications for Dry Eye Disease. Clin Ophthalmol. 2020;14:875-883. doi:10.2147/OPTH.S233194 3. Messmer EM. The pathophysiology, diagnosis, and treatment of dry eye disease. Dtsch Arztebl Int. 2015;112:71-81. 4. Farrand KF, Fridman M, Stillman IÖ, Schaumberg DA. Prevalence of diagnosed dry eye disease in the United States among adults aged 18 years and older. Am J Ophthalmol. 2017;182:90-98. 5. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II Pathophysiology Report. Ocul Surf. 2017;15:438-510. 6. Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017;15:334-365. 7. Walker PM, Lane KJ, Ousler GW, 3rd, Abelson MB. Diurnal variation of visual function and the signs and symptoms of dry eye. Cornea. 2010;29(6):607–612. 8. Kawashima M, Uchino M, Yokoi N, et al. The association of sleep quality with dry eye disease: the Osaka study. Clin Ophthalmol. 2016;10:1015-1021. 9. Yamada M, Mizuno Y, Shigeyasu C. Impact of dry eye on work productivity. Clinicoecon Outcomes Res. 2012;4:307-312.