Tarsius Pharma announced that the European Medicines Agency (EMA) approved the designation of orphan drug for its TRS for treatment of noninfectious uveitis and has acknowledged the clinically relevant advantage for TRS in noninfectious uveitis patients with glaucoma not eligible for corticosteroid treatment, according to a company news release.
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,” Daphne Haim-Langford, PhD, Tarsius Founder and CEO, said in the news release.
“This is the first time that authorities are formally recognizing the unmet need of patients suffering from uveitis associated with glaucoma,” Ron Neumann, MD, Tarsius CMO, said in the news release. “This approval enables us to proceed to phase 1/2 in our clinical trials, supported by the acknowledgment of the EMA of the indication.”