In a recent news release, pharmaceutical company Tarsier Pharma (“Tarsier”) shared that it held a successful pre-Investigational New Drug (pre-IND) meeting with the FDA. The meeting focused on TRS02, a therapy designed to treat patients with a variety of ocular disorders. Now, the company can work on continuing to develop TSR02 in a more targeted and successful way.
Altogether, TSR02 is designed to target inflammatory conditions affecting the back of the eye. For example, TSR02 could be used for patients with diabetic macular edema, posterior or intermediate uveitis, and non-proliferative diabetic retinopathy. The therapy is administered intravitreally as an injection.
According to the FDA:
The pre-IND meeting can be very valuable in planning a drug development program, especially if sponsors’ questions are not fully answered by guidances and other information provided by FDA. Early interactions with FDA staff can help to prevent clinical hold issues from arising [and a] pre-IND meeting can also provide sponsors information that will assist them in preparing to submit complete investigational new drug applications.
During Tarsier’s meeting, the company discussed:
- Endpoint approaches when crafting clinical study designs
- Information regarding clinical strategy and non-clinical study requirements
- Guidance regarding Chemistry, Manufacturing, and Control (CMC) requirements on slow-release TSR02
One of the conditions TSR02 is designed to treat is uveitis. Altogether, uveitis is characterized by uveal inflammation. The uvea, or the middle layer of the eye, normally protects the eyeball and provides blood to the retina. But visual issues can occur when the uvea becomes inflamed. Normally, uveitis occurs between ages 20-60. It can occur in one or both eyes. There are numerous forms of uveitis. For example, iritis (anterior uveitis) is the most common form, affecting the front of the eye. Next, cyclitis (intermediate uveitis) affects the ciliary body, which sits between the iris and choroid. Then there is choroiditis (posterior uveitis), which is the most uncommon form. Choroiditis impacts the retina and/or optic nerve and could cause permanent vision loss. Finally, pan-uveitis impacts all parts of the eye.
But what causes uveitis? To be honest, doctors are not always sure. However, some causes include eye injury or surgery; autoimmune disorders; infections; eye cancer; or toxins in the eyes.
When symptoms appear, please see a doctor immediately. These include:
- Rapidly worsening vision loss
- “Floaters” in your field of vision
- Eye redness and pain
- Light sensitivity
- Blurred vision