HanAll Biopharma and Yuyu Pharmaceutical are accelerating efforts to develop dry eye treatments, witnessing a global increase in the prevalence of the disease, also known as xerophthalmia.
According to a study published in the Ophthalmic and Physiological Optics, a research journal of optometrists, the syndrome affected one in 11 people worldwide in 2021.
The disease is also becoming more prevalent in Korea, with the Health Insurance Review and Assessment Service reporting that the number of dry eye symptoms patients was 2.45 million as of 2020, a sharp increase from 1.86 million reported 10 years ago.
However, FDA-authorized treatments have limitations such as inadequate treatment efficacy and side effects such as a burning sensation.
Against this backdrop, the FDA established a clinical guideline for the treatment of dry eye syndrome in Dec. 2020 to accelerate the development of treatments that can address such unmet medical needs.
It the first time that the FDA had set a clinical guideline for dry eye syndrome treatment.
In Korea, the Ministry of Food and Drug Safety also published a clinical guideline on Sept. 16.
“A clear endpoint and evaluation method for conducting a clinical trial for dry eye syndrome treatment have a significant impact on the success of the trial,” a company official developing a dry eye treatment said, asking to remain anonymous. “Therefore, the FDA and MFDS’ detailed guidelines have increased the possibility of successfully developing a new drug, which, in turn, has raised interest from global pharmaceutical companies to develop a treatment.”
With the establishment of clinical guidelines, many pharmaceutical companies worldwide are already accelerating the development of a dry eye syndrome treatment.
Such candidates include HanAll Biopharma’s tanfanercept, Yuyu Pharmaceutical’s YP-P10, Aldeyra Therapeutics’ Reproxalap, and Okyo Pharma’s OK-101.
HanAll’s tanfanercept is an anti-tumor necrosis factor (TNF) alpha protein drug co-developed with Daewoong Pharmaceutical for the treatment of Dry eye symptoms and other inflammatory eye conditions.
According to HanAll, while conventional drugs aim only to relieve symptoms and prevent the disease progression, tanfanercept aims to address the underlying causes of dry eye symptoms by inhibiting TNF alpha, a factor that prompts inflammation on the ocular surface.
HanAll Biopharma and its parent firm Daewoong Pharmaceutical are currently conducting their second phase 3 clinical trial of tanfanercept in the U.S.
Harbour Biomed, HanAll’s Chinese partner, is also conducting phase 3 clinical trial for tanfanercept in China.
Yuyu Pharmaceutical is conducting phase 2 clinical trial of YP-P10, which is a novel drug that uses synthetic peptides to treat dry eye syndrome.
YP-P10 proved more effective than Lifitegrast, an existing xerophthalmia treatment, in lowering inflammatory cytokine and chemokine production in human peripheral blood mononuclear cells (PBMC) when vitalized through Lipopolysaccharide (LPS) in previous clinical trials.
It also reduced inflammatory mediators and improved corneal damage through additional research on animals.
Aldeyra Therapeutics, a U.S. pharmaceutical company, is developing reproxalap, a novel inhibitor of RASP that is a new anti-inflammatory pathway for dry eye symptoms.
As RASP binds to cellular biomolecules, it disrupts their function and activates pro-inflammatory mediators. Several clinical trials have demonstrated reproxalap to demonstrate statistically significant and clinically relevant activity for dry eye disease.
Aldeyra has reported reproxalap to act as a small molecule reducing excessive RASP levels.
Okyo Pharma, a U.K.-based pharmaceutical company, is examining the potential of G protein-coupled receptors (GPCRs) as a target for dry eye symptoms.
OK-101 is an antagonist of the G-protein-coupled receptor typically found on the immunological cells of the eye.
The substance produces anti-inflammatory and reduces pain by combating washout through the inclusion of the lipid anchor contained in the drug molecule.