Tarsius Pharma announced the European Medicines Agency (EMA) approved the designation of orphan drug for its TRS for treatment of non-infectious uveitis and has acknowledged the clinically relevant advantage for TRS in non-infectious uveitis patients with glaucoma not eligible for corticosteroid treatment. The EMA further stated in their decision that use of TRS will be of "significant benefit to those affected by the condition, which is chronically debilitating due to visual loss, leading to significant visual impairment or legal blindness in up to 35% of patients."
Orphan drug designations facilitate development of drugs for rare diseases.
"I am pleased that the EMA acknowledges the potential of our TRS to treat those patients suffering from uveitic glaucoma, who have no safe treatment available and have a high risk for blindness," Dr. Daphne Haim-Langford, Tarsius Founder and CEO, said.
"This is the first time that authorities are formally recognizing the unmet need of patients suffering from uveitis associated with glaucoma," said Dr. Ron Neumann, Tarsius CMO. "This approval enables us to proceed to Phase I/II in our clinical trials, supported by the acknowledgment of the EMA of the indication."
Ocular inflammatory diseases impose a significant medical and economic burden on society, affecting hundreds of million people worldwide and posing severe risks of vision loss and blindness.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
In more than 50 years, corticosteroids are the most common method used to treat ocular non-infectious inflammation of any kind. Rather than treating the disease itself, however, steroids merely relieve its symptoms, and long-term use can result in life-changing consequences.
The TRS Platform Technology has the potential to effectively treat a broad array of autoimmune and inflammatory ocular diseases.