Domestic pharmaceutical firms are speeding up the development of eye disease treatments such as dry eye syndrome.
The widespread use of smartphones and the worsening of fine dust pollution in the modern era has given rise to the number of people with eye disease in the country, making it a potentially big market for pharmaceutical companies.
The eye disease market is growing dramatically, due to the steadily increasing number of patients with eye diseases such as macular degeneration, diabetic retinopathy, and fundus disease.
According to the Korea Biotechnology Industry Organization, the global ophthalmic disease market is expected to grow at an average annual rate of 7 percent. Data showed that the market grew to $31.7 billion last year from $27.7 billion in 2017. The industry expects the market to grow further in 2021 to about $36.3 billion.
Multinational pharmaceutical companies currently dominate the eye disease market with the top five companies accounting for about 65 percent of the global eye disease therapy market.
Novartis has the highest share of roughly 23 percent, followed by Roche with 15 percent, Allergan with 13 percent, Valiant with 7 percent, and Bayer with 6.5 percent.
Korean pharma makes rapid progress in eye disease market
|Dry eye syndrome||Huons||HU-007|
|Dry eye syndrome||GtreeBNT||RGN-259|
|Dry eye syndrome||Hanall Biopharma||HL036|
|Macular degeneration||Olix Pharmaceutical||OLX301A|
|Macular degeneration||Samsung Bioepis||SB11|
|Macular degeneration||Samsung Bioepis||SB15|
|Fundus disease||Bridge Biotherapeutics||Oral fundus disease drug|
Against this background, experts have placed high hopes on the commercialization of locally developed dry eye treatments.
Huons is currently in the lead for commercializing its nano combination eye drops HU-007, a treatment for dry eye.
HU-007 is a combination of anti-inflammatory cyclosporine and eye-protecting trehalose. The treatment reduced the amount of cyclosporine used compared to cyclosporine alone. It also enhanced therapeutic action, including superior tear film protection and anti-inflammatory effects.
Huons confirmed the safety and efficacy of the combination therapy, especially in regards to the tear film protection and anti-inflammatory effects on dry eye stemming from multiple causes in phase 2 clinical trial completed in April 2017.
Huons aims to obtain approval for sales this year after completing phase 3 clinical trials in the first half of this year.
Industry insiders also have high expectations of biotechnology company GtreeBNT as it completes the phase 3 clinical trial for its dry eye treatment RGN-259 in the US. The company expects results in the third and fourth quarters of this year.
RGN-259's primary ingredient is thymosin beta4, a novel mechanism that induces re-epithelialization of damaged corneas through cell migration and intercellular adhesion. RGN-259 also acts to inhibit corneal epithelial damage and inflammation.
Hanall Biopharma's dry eye treatment HL036 has also returned as a potentially promising therapy after having failed to meet key indicators in its first phase 3 trial.
HL036 is a biological drug that has molecularly improved TNF receptor fragments using Hanall Biopharma's proprietary Resistein technology.
Although topline results from the VELOS-2 phase 3 clinical trial failed to demonstrate statistical significance in the key endpoints, sub-assessment indicators showed significant results.
The trial analysis showed significant results in sub-assessment indicators such as the Superior Corneal Staining Score (SCSS), Center Corneal Staining Score (CCSS), and Total Corneal Staining Score (TCSS).
In light of the findings, the company said that it would change the evaluation index by making the sub-assessment indicators as the key indicators and proceed with a phase 3 trial.
Aside from dry eye treatments, local firms are also developing treatments for specific eye diseases such as macular degeneration and fundus disease.
Macular degeneration is a disease that causes vision loss due to necrosis of tissues in the central retina. The two types of macular degeneration are dry and wet macular degeneration. Ninety percent of patients have dry macular degeneration, while 10 percent have wet macular degeneration.
In the case of wet macular degeneration treatment, the market size is about 15 trillion won. However, there have been reports of side effects of existing treatment, and there is no treatment for dry macular degeneration as of yet.
Olix Pharmaceuticals is developing OLX301A, an RNAi-based treatment for dry and wet macular degeneration.
Olix unveiled the OLX301A's test on primates last year. The trial was carried out by inducing wet macular degeneration in the eyes of 16 rhesus monkeys, known to be most similar to human genes. As a result, the treatment effect lasted for 56 days (8 weeks) or more with a single administration.
Among biosimilars, Samsung Bioepis' SB11 known as Lucentis (ranibizumab), and SB15 known as Eylea (aflibercept), is of interest.
At the end of last year, Samsung Bioepis completed phase 3 clinical trials on the efficacy and safety of Lucentis in 705 patients with wet age-related macular degeneration
Samsung Bioepis plans to collect phase 3 clinical data of SB11 and announce the results this year and apply for a marketing license in Europe and the United States.
The company also announced that SB15 is currently entering preclinical trials this year.
Also, Bridge Biotherapeutics initiated development for a new candidate drug for fundus disease with Konkuk University Industry-Academic Cooperation Group.
Bridge Biotherapeutics will acquire exclusive licenses worldwide under this agreement and will conduct additional joint research with Konkuk University's research team. BridgeBio will lead the independent development from all clinical stages.