Hanall’s dry eye treatment underwhelms in clinical trial

Another clinical trial by a Korean company has failed, the latest in a series of disappointing outcomes for the sector.

In this case, it was a Phase 3 trial of a dry eye treatment by Hanall Biopharma. The treatment was co-developed by Daewoong Pharmaceutical, which owns 30 percent of Hanall Biopharma.

At a press conference Wednesday, Hanall Biopharma announced that HL036 failed to achieve statistically meaningful results in a trial in the United States.

In the eight-week program, half of the 637 dry eye patients received HL036, while the rest received a placebo.

Hanall Biopharma CEO Park Seung-kook said the treatment and placebo performed similarly in terms of the inferior corneal staining score and the ocular discomfort score.

But Park said that HL036 did show statistically better results in terms of the superior corneal staining score and corneal staining score when compared to the placebo.

The treatment candidate also performed better in terms of the alleviation of eye dryness than Xiidra, a competing product from Novartis.

Although Hanall Biopharma could not achieve meaningful results in the latest trial, Park said in a statement that the fact that HL036 showed better results when compared to Xiidra means HL036 could be more competitive in the market if approved.

The disappointing initial clinical trial pushes back an approval from the U.S. Food and Drug Administration (FDA) for HL036 by more than a year.

Hanall Biopharma was initially hoping to market HL036 in 2022 and early 2023 on the basis of two Phase 3 clinical trials. But as the first didn’t yield the desired results, the company said it is going to conduct one more clinical trial after discussing the matter with the FDA.

Daewoong Pharmaceutical purchased its stake in Hanall for 104.6 billion won ($89.7 million) in 2015.

BY KO JUN-TAE, KANG JAE-EUN [ko.juntae@joongang.co.kr]