OTX-TIC (travoprost intracameral implant)

SEEKS TO ADDRESS THE ISSUE OF PATIENT NON-COMPLIANCE WITH EYE DROPS

OTX-TIC is designed to be a bioresorbable intracameral implant containing micronized travoprost that is injected into the anterior chamber of the eye and is intended for patients with glaucoma or ocular hypertension with a target duration of drug delivery of four to six months. OTX-TIC is designed to directly address patient compliance issues by delivering travoprost over the course of several months with a single implant.

EXISTING TREATMENTS

  • High rates of non-adherence to glaucoma therapies1-3
  • Poor adherence has been shown to be associated with disease progression and vision loss5,6
  • Ocular hyperemia#
  • Life-long daily burden of patient administration#

PRODUCT CANDIDATE ATTRIBUTES

  • Travoprost loaded microparticles embedded in hydrogel
  • Administered with 27G or 26G needle
  • Resides in the iridocorneal angle
  • Fully biodegradable

Plan to initiate Phase 2 clinical trial in mid-2021

Caution: NEW DRUG – OTX-TIC 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.

Intracameral injection of OTX-TIC

“Compliance with topical drop therapy remains a clinical problem in the treatment of glaucoma… OTX-TIC, if shown to be safe and effective, represents a possible solution to this problem.”
– Michael Goldstein, President, Ophthalmology and CMO – 1/20/2021

Injection of OTX-TIC implant in the anterior chamber of the eye. Implant drops down and resides in the iridocorneal angle. (image)

Injection of OTX-TIC implant in the anterior chamber of the eye.
Implant drops down and resides in the iridocorneal angle.

About Glaucoma

Glaucoma is a disease that damages your eye’s optic nerve.6 It usually happens when fluid builds up in the front part of your eye, thereby increasing intraocular pressure (IOP). Elevated IOP is associated with damage to the optic nerve, which may result in irreversible vision loss.6 Glaucoma is the second leading cause of blindness in the world.7 The Glaucoma Research Foundation estimates that over three million Americans have glaucoma.9 To lower IOP, physicians typically initiate treatment by prescribing drugs administered as eye drops10. The classes of topical drugs used to treat glaucoma include prostaglandin analogs, or PGAs, beta-blockers, alpha-adrenergic agonists and carbonic anhydrase inhibitors.11,12 These drugs decrease IOP by either decreasing fluid production or enhancing fluid drainage.11,12 PGAs are the most widely prescribed class of drugs for glaucoma and are considered first-line glaucoma treatment.10 PGAs reduce IOP by enhancing the clearance and drainage of ocular fluid.11 The most frequently prescribed PGA is once-daily latanoprost, although travoprost, unoprostone and bimatoprost are also frequently used in the management of open-angle glaucoma.12 In cases where glaucoma is not easily managed by a drug regimen, surgical or laser treatments may be undertaken.10

According to IMS Health data, approximately 35.6 million prescriptions were filled in the United States in 2019 for drugs administered by eye drops for the treatment of glaucoma, resulting in sales of approximately $3.3 billion. A typical prescription provides approximately one month of treatment. We expect prescription volume to grow, in large part as a result of the aging population. According to IMS Health, PGAs accounted for approximately half of the prescription volume in the glaucoma market in 2019.

Implant Visualization

OTX-TIC visualization (image)

OTX-TIC visualized in a patient through a slit lamp in the Phase 1 clinical trial.

REFERENCES: 1. Olthoff CM, et al. Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review. Ophthalmology. 2005; 112:953–61. 2. Schwartz GF, et al. Adherence and persistence with glaucoma therapy. Surv Ophthalmol. 2008; 53(suppl1):S57–68. 3. Nordstrom BL, et al. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005; 140:598–606. 5. Sleath B, et al. The relationship between glaucoma medication adherence, eye drop technique, and visual field defect severity. Ophthalmology. 2011; 118:2398–402. 6. Caprioli, J. & Coleman, A. L. Intraocular pressure fluctuation a risk factor for visual field progression at low intraocular pressures in the advanced glaucoma intervention study. Ophthalmology 115, 1123–1129.e3 (2008). 7. Boyd K. What Is Glaucoma? American Academy of Ophthalmology. https://www.aao.org/eye-health/diseases/what-is-glaucoma#:~:text=Glaucoma is a disease that,eye, damaging the optic nerve. Published December 14, 2020. Accessed February 2, 2021. 8. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90(3):262-267. doi:10.1136/bjo.2005.081224. 9. Glaucoma Facts and Stats. Glaucoma Research Foundation. https://www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php. Accessed February 2, 2021. 10. Primary Open-Angle Glaucoma PPP 2020. American Academy of Ophthalmology. https://www.aao.org/preferred-practice-pattern/primary-open-angle-glaucoma-ppp. Published January 5, 2021. Accessed February 2, 2021. 11. Beidoe G, Mousa SA. Current primary open-angle glaucoma treatments and future directions. Clin Ophthalmol. 2012;6:1699-1707. doi:10.2147/OPTH.S32933. 12. Li T, Lindsley K, Rouse B, et al. Comparative Effectiveness of First-Line Medications for Primary Open-Angle Glaucoma: A Systematic Review and Network Meta-analysis. Ophthalmology. 2016;123(1):129-140. doi:10.1016/j.ophtha.2015.09.005.