Korean bio, pharmaceutical industries pursue dry eye treatment breakthrough

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South Korean pharmaceutical and biotechnology companies are engaged in efforts to develop a cure for dry eye disease, an area that is considered complex, amid a surge in patients due to increased smartphone usage and worsening air quality.

According to industry sources on Tuesday, HanAll Biopharma has outlined plans to enter a phase 3 clinical trial for its dry eye syndrome candidate, HL036, in the United States early next year.

This marks the third phase 3 trial attempt for the medication in the U.S. alone.

HL036 failed to meet the primary endpoint during the second phase 3 trial conducted in May, but the company made the decision to redesign the clinical trial in pursuit of regulatory approval.

“We will discuss with the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for HL036 this year, with the goal of commencing the study again next year,” said a company official.

The company places significant hope in one of the secondary endpoints of the phase 2 trial, known as the Schirmer test, which measures tear production in patients with dry eye syndrome.

According to the FDA, dry eye clinical trials typically require a statistically significant improvement in both subjective symptoms and objective signs.

However, if the Schirmer test shows a statistically significant difference in patient response, with an improvement of 10 mm or more, it can demonstrate efficacy without the need for subjective symptom improvement.

Given the promising results from the previous phase 3 trial, the company is expected to make the Schirmer test a key endpoint in future clinical trials.

HanAll Biopharma is concurrently conducting its second phase 3 clinical trial for HL036 in China.

HLB Therapeutics is also engaged in its fourth phase 3 clinical trial for the dry eye syndrome drug RGN-259. Since 2015, the company’s U.S. subsidiary, ReGenTree, had conducted three clinical trials with changing primary endpoints, but failed to demonstrate efficacy.

Dry eye syndrome is a condition that arises due to insufficient tear production caused by factors such as eye surface damage and inflammation.

Common symptoms include a stinging or gritty sensation in the eyes, along with the feeling of foreign particles present. The diverse causes of the condition and the difficulty in demonstrating efficacy have classified dry eye syndrome as a particularly challenging area for new drug development and discovery.

Companies, nonetheless, are pursuing a breakthrough as they project market growth.

According to research from Research and Markets, the global dry eye syndrome market is projected to grow by about 7 percent annually from 2020, reaching $5.5 billion by 2030.

In the U.S., nearly 15 percent of the population is known to suffer from dry eye syndrome.

FDA-approved products for this condition have been limited to Novartis’ Xiidra and AbbVie’s Restasis, with existing treatments primarily focused on symptom relief rather than providing a fundamental cure.

Another Korean pharmaceutical firm, Huons, is also at the forefront of dry eye syndrome treatment development.

The company is currently developing three different dry eye syndrome treatments, with one of them, HU007, undergoing phase 3 clinical trials in its home market.

After an unsuccessful application for approval in 2020, the company has reattempted the process and is now aiming for marketing approval by 2025. Huons is also working on three other dry eye syndrome treatments. Huons’ strategy is to develop different mechanisms of action for each of these treatments to address the growing demand in the market.

However, some companies are reevaluating the competitiveness of their drug candidates due to their inability to demonstrate efficacy during clinical trials.

Yuyu Pharma, for instance, faced challenges with its dry eye syndrome drug, YP-P10, during a phase 2 clinical trial in the U.S., where it failed to meet the primary endpoint.

The company is now considering various options, from altering the clinical trial design to potentially discontinuing the development.