Novel TNF-Alpha Inhibitor Improved Signs, Symptoms of Dry Eye

Tanfanercept 0.25% ophthalmic solution was effective at improving certain signs and symptoms of dry eye disease (DED) compared with placebo, according to a poster presented at the American Academy of Ophthalmology 2020 Virtual meeting.

“Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles,” according to a poster by Youngju Kim, MS, of HanAll BioPharma Co., Korea.

Tanfanercept is a tumor necrosis factor-alpha receptor inhibitor. The VELOS-2, phase-3 trial was designed to evaluate the safety and efficacy of tanfanercept ophthalmic solution 0.25% compared with placebo in 637 patients with mild to moderate DED. The primary endpoints were inferior corneal staining score (ICSS) and ocular discomfort score (ODS).

Tanfanercept did not improve ICSS compared with placebo at week 8. However, there were improvements in ODS at week 2 and week 4 compared with placebo.

Tanfanercept also significantly improved central corneal staining score (P=.024) and total corneal staining score (P=.045) at week 8 compared with placebo. The difference in superior staining scores at week 8 was numerically improved but not statistically significant (P=.0586).

Sign improvement in CCSS was observed at week 8 for tanfanercept in the subgroup of more severe patients at baseline (P=.0001). Tanfanercept also significantly improved EDS at week 8 in patients who used artificial tears within 1 month of their first visit (P=.033).

There were no serious adverse events related to the drug, and treatment-emergent adverse events were similar between tanfanercept 0.25% and placebo ophthalmic solution groups.

This study was designated a “Best Poster” by AAO 2020 Virtual meeting organizers.