When it comes to pharmaceuticals, licensed territory helps ensure that drugs within a certain territory are offered to patients. Exclusive licenses sometimes mean that pharmaceuticals are only available in specific areas, but not to patients in other locations. For example, ARVN001 (triamcinolone acetonide suprachoroidal injectable suspension), developed for patients with uveitic macular edema (UME), was licensed in Greater China and South Korea. According to a recent news release, biotechnology company Arctic Vision worked with biopharmaceutical company Clearside Biomedical, Inc. to expand this licensed territory to now include India and the ASEAN countries. Although ARVN001 is not yet approved for patient use, this expansion is a crucial step in ensuring that, once approved, the treatment will be available to all patients in need within these jurisdictions.
To begin, what exactly is ARVN001? According to Arctic Vision, ARVN001 is a proprietary suspension of triamcinolone acetonide which is administered via injection into the suprachoroidal space, which is located between the choroid and sclera. The therapy is designed to allow quick treatment to the suprachoroidal space while also minimizing potential damage to the other areas of the eye. Additionally, its targeted administration allows for longer-lasting effects. While the New Drug Application (NDA) was accepted within the United States earlier this year, Arctic Vision is still working to develop the therapy within Asia. Moving forward, Arctic Vision will be holding a Phase 3 clinical trial in China to evaluate the therapy for patients with UME.
Altogether, uveitis acts as an umbrella term for disorders causing inflammation within the uvea, or the middle layer of the eye. Normally, the uvea protects the eyeball from damage while providing blood supply to the retina. However, when inflammation occurs, it causes issues with vision, including potential vision loss. Uveitis may affect one or both eyes and comes in a variety of forms. For example, cyclitis affects the ciliary body, while anterior uveitis affects the front of the eye, and posterior uveitis affects the retina and optic nerve. If patients experience inflammation throughout the entire eye, this is known as pan-uveitis. Typically, uveitis occurs between ages 20-60. Causes include eye injury or surgery, infections, autoimmune or inflammatory disorders, or even toxin exposure. Symptoms include:
- Eye pain and redness
- Light sensitivity
- Blurred vision
- “Floaters” in the field of vision
- Decreased vision
- Macular edema (fluid buildup in the macula)
Uveitis-associated macular edema (UME) is a commonly occurring complication associated with uveitis. As the macula swells and distorts, it can cause additional symptoms, such as:
- Washed out colors
- “Wavy” vision