Amended agreement to develop a novel, sustained-release formulation of EYLEA® (Aflibercept)
OTX-AFS is an extended-delivery formulation of aflibercept for the treatment of retinal diseases.1
EYLEA is a vascular endothelial growth factor (VEGF) trap approved for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases2
- EYLEA is a global market leader with $7.5 billion in revenue in 20193,4
- Please go to www.EYLEA.us for full Prescribing Information
Evaluating opportunity to incorporate aflibercept with our sustained release hydrogel for injection in the suprachoroidal space
- Goal is to overcome limitations of intravitreal injections and extend aflibercept’s duration of activity, thereby decreasing dosing frequency
- Regeneron subsidizes Ocular’s formulation efforts
- Regeneron to fund personnel and material costs associated with pre-clinical development
- Regeneron to fund up to $305 million in milestone payments with royalties in high single digits to low-to-mid-teens as a % of net sales
- Includes only large molecule anti-VEGFs
Caution: OTX-AFS is currently undergoing preclinical 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.5 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 2050.6 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).8,9 Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss.10 With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision.11 Challenges with current therapies include repeated intraocular injections every 1-2 months, treatment-related adverse events, patient compliance, and lack of vision improvement.12
*Formerly known as OTX-IVT (aflibercept intravitreal injection)
REFERENCES: 1. Ocular Therapeutics March 11, 2021 press release. https://ocutx.gcs-web.com/node/10531/pdf. Accessed March 12, 2021. 2. EYLEA (aflibercept) [prescribing information]. Tarrytown, NY: Regeneron Pharmaceutical, Inc.; 2019. 3. 2019 Regeneron annual report. https://investor.regeneron.com/static-files/cbebda5b-c02d-466b-8be9-e0d8a4052cf8. Accessed March 10, 2021. 4. Blankenship K. https://www.fiercepharma.com/pharma/regeneron-builds-preventative-case-for-eylea-new-2-year-data. Accessed March 12, 2021. 5. Schmidt-Erfurth U, et al. Br J Ophthalmol. 2014;98(9):1144-1167. 6. National Eye Institute. 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. Accessed January 22, 2021. 7. Gehrs KM, et al. Ann Med. 2006;38:450-471. 8. Kvanta A, et al. Invest Ophthalmol Vis Sci. 1996;37:1929-1934. 9. Yeo NJY, et al. Front Pharmacol. 2019;10:1363. 10. Ramakrishnan MS, et al. Graefes Arch Clin Exp Ophthalmol. 2020 Sep 30. 11. Maguire MG, et al. Ophthalmology. 2016;123(8):1751-1761. 12. Okada M, et al. Ophthalmology. 2021;12:234-247.