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.
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 diseases
- EYLEA is the global market leader with $7.5 billion in revenue in 20191
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: NEW DRUG – OTX-AFS 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.
“We have made considerable progress in developing our protein drug delivery platform at Ocular Therapeutix, so it is good to see an industry leader such as Regeneron recognizing the potential of this technology.”
– Amar Sawhney, Ph.D., Hydrogel Platform Founder – 10/13/2016
About Wet Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is a leading cause of severe, irreversible vision loss2. 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 20502. The most common form of AMD is the non-neovascular or dry form, which afflicts most patients and represents the early and intermediate stages of the disease3. As the disease progresses, approximately 15% of patients will develop the more advanced neovascular form of AMD3. Neovascular AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascular in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF)4. Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss3. With proper treatment, patients usually maintain visual function and may temporarily regain lost vision5. Challenges with current therapies include repeated intraocular injections every 1-2 months, treatment-related adverse events, patient compliance, and lack of vision improvement6.
REFERENCES: 1. 2019 Regeneron annual report 2. National Eye Institute. Age-Related Macular Degeneration (AMD) Data and Statistics, 2019. Available: 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: 22 January 2021. 3. Gehrs KM, Anderson DH, Johnson LV, Hageman GS. Age-related macular degeneration–emerging pathogenetic and therapeutic concepts. Ann Med. 2006;38:450-471. 4. Kvanta A, Algvere PV, Berglin L, Seregard S. Subfoveal fibrovascular membranes in age-related macular degeneration express vascular endothelial growth factor. Invest Ophthalmol Vis Sci. 1996;37:1929-1934. 5.Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group, Maguire MG, Martin DF, et al. Five-Year Outcomes with Anti-Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration: The Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology. 2016;123(8):1751-1761. doi:10.1016/j.ophtha.2016.03.045. 6. Okada M, Mitchell P, Finger RP, et al. Nonadherence or nonpersistence to intravitreal injection therapy for neovascular age-related macular degeneration: a mixed-methods systematic review. Ophthalmology. 2021;12:234-247.
*Formerly known as OTX-IVT (aflibercept intravitreal injection)