- Taiwan FDA approved the Phase-II clinical trial for dry eye disease.
- The patent of dry eye treatment was granted in Taiwan, ROC. (Patent Number: I796875)
- Thailand FDA approved the Phase-II clinical trial for dry eye disease.
- Australia approved to test the novel oligonucleotide drug for a phase2 trial for dry eye disease
- Appointing Deloitte to review and audit tax and financial report
- 2022 Taipei Biotech Award.
- US FDA and Taiwan FDA approved the Phase-I IND in 2021.
- Phase 1 Clinical Study was successfully completed 1n 2021.
- China Patent Office granted the anti-myopia patent application (Patent Number: CN107922948B)
- US FDA approved the IND application for phase I clinical trial in 28 days!
- European Patent Office granted the anti-myopia patent application.
- 2020 Taiwan Ministry of Economic Affairs; “Break Out and Soar High” Award
- The Founder was selected as an elite in translational science by Taiwan government
- The anti-myopia patent was granted in Korea
- The anti-myopia patent was granted in Japan
- The anti-myopia patent was granted in the USA
- The anti-myopia patent was granted in Taiwan, ROC
In the early research stage, the research team in the medical schools received generous financial and administrative supports from the Taiwan Ministry of Science and Technology to develop the proprietary RNA therapy technology and compounds to control myopia progression in pediatric subjects.
With the assistance from the Taiwan Startup Institute, the team established Sunhawk Vision Biotech, Inc., a drug development company, in August 2019. The Company takes over the job from the academic research institute to continue the translation of early R&D results to the final ophthalmic product.
In January 2021, Sunhawk filed the IND to the US FDA for the first-in-human Phase-I trial to test the safety of the newly developed RNA therapeutic eye drops. The IND application received an early approval from the US FDA in February 2021 without any comments/revisions requested by US FDA. The first-in-human Phase-I clinical trial (NCT04928144) was completed in 2021 Q3, and the results showed no drug-related adverse event, high tolerability by the pediatric study subjects. A great therapeutic potential was also suggested.
It is expected that the investigative drug will successfully enter Phase 2 and Phase 3 trials and will enter the global market in next few years.
In April 2021, the same research team established Dreamhawk Vision Biotech, Inc. The Company focuses on the research and development of oligonucleotide drugs for ocular diseases other than myopia, based on the RNA therapy platform. Indications that are currently under development include dry eye disease and ocular surface diseases.
Dreamhawk Vision Biotech, Inc recently reported the excellent effect of our oligonucleotide drug, SHJ002, in treating dry eye disease via novel mechanism of action including fast corneal repair, a reduction of corneal apoptosis, improvement of Meibomian gland and an increase of mucin production and secretion. SHJ002 sterile ophthalmic solution, an oligonucleotide drug for RNA therapy, is currently used for a Phase-II trial for dry eye disease (NCT05486728). This Phase-II clinical trial is undergoing in Australia, Taiwan, and Thailand.
- Dr. Liang
- Dr. Hank Juo
Recommended myopia paperslink to recommended research articlesmore+
Recommended myopia papers
miR-328-3p affects axial length via multiple routes and anti-miR-328-3p possesses a potential to control myopia progression. Invest Ophthalmol Vis Sci. 2022 Nov 1;63(12):11
Interventions recommended for myopia prevention and control among children and adolescents in China: a systematic review. Br J Ophthalmol. 2021 Nov 29;bjophthalmol-2021-319306.
Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708.
Atropine slows myopia progression more in Asian than white children by meta-analysis. Optom Vis Sci. 2014 Mar;91(3):342-50.
MicroRNA-328 may influence myopia development by mediating the PAX6 gene. Invest Ophthalmol Vis Sci. 2012 May 31;53(6):2732-9.
Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study. Jpn J Ophthalmol. 2021 May;65(3):315-325.
Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. Ophthalmology. 2019 Jan;126(1):113-124.
Recommended dry eye paperslink to recommended research articlesmore+
Recommended dry eye papers
Inhibition of microRNA-328 Increases Ocular Mucin Expression and Conjunctival Goblet Cells. Biomedicines 2023, Jan 19; 11(2):287
microRNA therapy for dry eye disease. Journal of Ocular Pharmacology and Therapeutics. 2022 Mar;38(2):125-132.
Advances in the diagnosis and treatment of dry eye, Prog Retin Eye Res. 2020 Jan 29:100842.
Lifitegrast for the Treatment of Dry Eye Disease Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60.
Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study. Ophthalmology. 2015 Dec;122(12):2423-31.
A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease. Ophthalmology. 2019 Jun;126(6):792-800.