Sustained-Release Product Candidate For Retinal Diseases
AXPAXLI (axitinib intravitreal implant), also referenced as laboratory code OTX-TKI (axitinib intravitreal implant), is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties being evaluated for the treatment of wet age-related macular degeneration (wet AMD), Diabetic Retinopathy (DR) and other retinal diseases.1,2
- Require intravitreal injections every 4-8 weeks3,4
- May cause endophthalmitis, ocular hemorrhage, damage to the lens or retinal detachment due to repeated injections5,6
- May cause discomfort, eye pain, vision blurred, and floaters4,7
Product Candidate Attributes1
- Targeting sustained release for 6 months or longer1
- Broad anti-angiogenic profile (small molecule)1
- Small fiber with minimal/no visual impact8
Caution: OTX-TKI 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.
About Wet Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is a leading cause of severe, irreversible vision loss.9,10 In the United States, the estimated number of people with AMD is expected to more than double from 2.07 million in 2010 to 5.44 million by 2050.10 The most common form of AMD is the non-exudative or dry form, which afflicts most patients and represents the early and intermediate stages of the disease.7 As the disease progresses, approximately 15% of patients will develop the more advanced neovascular (wet) form of AMD.7 Neovascular AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF).11,12 Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss.9 With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision.13 Challenges with current therapies include repeated intraocular injections every 1-2 months, treatment-related adverse events, patient compliance, and lack of vision improvement.4,14
REFERENCES: 1. Boyer DS, et al. Evaluating Safety, Tolerability and Biological Activity of OTX-TKI, a Hydrogel-Based, Sustained-Release Intravitreal Axitinib Implant, in Subjects with Neovascular Age-Related Macular Degeneration. Presented at the AAO Annual Meeting; November 13-15, 2020; Virtual. 2. Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy. ClinicalTrials.gov. Updated February 21, 2023. Accessed February 23, 2023. https://clinicaltrials.gov/ct2/show/NCT05695417. 3. EYLEA® (aflibercept) [prescribing information]. Tarrytown, NY: Regeneron Pharmaceutical, Inc.; 2019. 4. LUCENTIS® (ranibizumab) [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2018. 5.Bochot A, et al. J Control Release. 2012;161(2):628-634. 6. Falavarjani KG, et al. Eye (Lond). 2013;27(7):787-94. 7. Gehrs KM, et al. Ann Med. 2006;38:450-471. 8. Csaky K, et al. Evaluating Safety, Tolerability and Biological Activity of OTX-TKI, a Hydrogel-Based, Sustained-Release Intravitreal Axitinib Implant, in Subjects with Neovascular Age-Related Macular Degeneration. Presented at the Euretina Congress; October 2-4, 2020; Virtual. 9. Schmidt-Erfurth U, et al. Br J Ophthalmol. 2014;98(9):1144-1167. 10. National Eye Institute. Eye Health Data and Statistics. Accessed June 26, 2023. https://www.nei.nih.gov/learn-about-eye-health/resources-for-health-educators/eye-health-data-and-statistics/age-related-macular-degeneration-amd-data-and-statistics. 11. Kvanta A, et al. Invest Ophthalmol Vis Sci. 1996;37:1929-1934. 12. Yeo NJY, et al. Front Pharmacol. 2019;10:1363. 13. Maguire MG, et al. Ophthalmology. 2016;123(8):1751-1761. 14. Okada M, et al. Ophthalmology. 2021;12:234-247.