HanAll Biopharma said on Wednesday that it started administering its dry eye disease treatment HL036 (tanfanercept) to patients in the second phase 3 VELOS-3 trial in the U.S.

HL036, being developed in collaboration with Daewoong Pharmaceutical in the U.S., is a biologic treatment that inhibits tumor necrosis factor (TNF), which aggravates dry eye by inducing inflammation in the eye.

The upcoming study aims to re-confirm HL036’s effect to improve center corneal staining score (CCSS) and eye dryness score (EDS), previously shown in phase 3 VELOS-2 trial in the U.S., on 300 patients with serious cases of dry eye at nine hospitals in the U.S.

HanAll Biopharma said it used its protein modifying technology “Registein” to strengthen HL036’s TNF neutralizing ability dramatically. The company said this would help demonstrate the treatment candidate’s potential to relieve inflammation and fundamentally treat dry eye.

The results of the VELOS-2 study demonstrated that the instillation of the eye drops did not cause foreign body sensations, making it convenient to use, the company said.

“HanAll Biopharma will mobilize all capabilities to make the VELOS-3 trial successful. I hope our new biologic drug could provide hope for patients suffering from dry eye around the world by eradicating the root cause of the disease,” said Jeong Seung-won, CEO of HanAll Biopharma.

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