Dermatology
Addressing Skin Conditions That Are Underserved
Scar Prevention
An estimated 100 million people in the developed world form scars following surgery (1). In the U.S. there are approximately eight million surgical procedures performed annually wherein scarring is a concern (2). Scarring results from abnormal deposition and organization of collagen, with no difference between normal and scarred skin in composition of dermal tissue. The pathogenesis of scar formation is poorly understood. Scarring can have negative physical, aesthetic, and psychological effects if left untreated. There are no approved drugs for scar prevention following surgery; treatments are limited to pressure dressings, silicone sheeting/gels, steri-strips, and steroid injections.
Rosacea
Rosacea is a common skin condition that affects over 16 million individuals in the U.S. and, according to some estimates, hundreds of millions of people worldwide (3). Rosacea is a chronic relapsing inflammatory skin disease primarily affecting the face. Rosacea comprises uncontrolled vasodilation, inflammation, and later fibrosis associated with glandular hyperplasia which presents as persistent erythema. This disease is thought to be under treated, as it’s often mischaracterized as acne. Current treatments consist of oral and topical medications that are taken or administered daily with limited efficacy.
AiViva is developing AIV-001 to address the negative impacts that scarring and rosacea can have on patients.
1. Sund, 2000. 2. American Society of Plastic Surgeons. 3. Berg M, Liden S. An epidemiological study of rosacea. Acta Dermato-Venereologica. 1989;69:419-423.
Ophthalmology
Addressing Unmet Needs in Neovascular AMD
Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular age-related macular degeneration (nAMD) is a chronic eye disorder that causes blurred vision or a blind spot in the visual field. It is generally caused by abnormal blood vessels that leak fluid or blood into the macula, the part of the retina responsible for central vision. Neovascular AMD affects 11 million people in the United States and is the leading cause of vision loss in people age 50 and older. The number of people with nAMD is expected to double as the population continues to age (1). The mainstay treatment modality for nAMD involves intravitreal (IVT) injectable anti-VEGF therapies, with the leading drugs accounting for approximately $8 billion in sales in 2018 (2). Anti-VEGF therapies have shown treatment success, however, the disadvantages of current treatment therapies include frequent visits to the Ophthalmologist for intravitreal injections, development of tolerance, and development of subretinal scarring (3, 4).
1. Pennington, K., et al. Epidemiology of age-related macular degeneration (AMD) 2. IMS Revenue Data & SEC filings 3. Daniel, E. et al. Risk of Scar in the Comparison of Age-related Macular Degeneration Treatments Trial, 2014. 4. Daniel, E. et al. Development and Course of Scars in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT), 2018.
Diabetic Macular Edema (DME)
DME is manifested as retinal thickening caused by the accumulation of intraretinal fluid, primarily in the inner and outer plexiform layers. It is believed to be a result of hyperpermeability of the retinal vasculature. DME can be present with any level of diabetic retinopathy.
In USA: The WHO (World Health Organization) estimates 15 million DME half undiagnosed and 50% of 8 million without eye care, 25-30% risk of vision loss from CSME. International, WHO estimates more than 150 million patients with diabetes worldwide. However, the absolute prevalence of DME might be increasing due to the overall increased prevalence of diabetes in industrialized nations. It is expected that the incidence of DME will decrease as excellent metabolic control is increasingly embraced as a therapeutic goal by patients and health care workers.
AiViva is developing AIV-007, its proprietary gel formulation, as a potentially once every 6-month injection to reduce the treatment burden for patients and physicians.
1. Albert and Jakobiec’s Principles and Practice of ophthalmology. Third edition, second volume. Canada: SAUNDERS ELSEVIER; 2008. pp. 1793–1996. 2. Pr Gabriel Coscas. Oedemes maculaires Aspects cliniques et therapeutiques.Spain: Springer Science & Business Media; 2011. Sep 15, pp. 110–196.