Formosa Pharmaceuticals Pipeline
Infectious Eye diseases Treatment｜APP13002
Target Product Profile ｜APP13002
Novel ophthalmic application of a known antibiotic as a homogeneous aqueous suspension and intended for development under the 505(b)(2) regulatory pathway.
Utilizing a non-fluoroquinolone antibiotic, which shows dual antibiotic and anti-inflammatory activity and broad antibacterial spectrum against the major pathogens of bacterial conjunctivitis.
Potential in treating multiple kinds of anterior Ocular Infections and discorders: Conjunctivitis, Keratitis, Blepharitis, Meibomian Gland Dysfunction (MGD).
Expected to have a more convenient dosing regimen with stable and non-irritating formulation superior to existing therapies.
Current treatments limitations and Unmet Needs｜APP13002
|Marketed antibiotic eyedrops||Opportunities for APP13002|
* Current leader of the infectious eye disease marke
* Broad antibacterial spectrum and good efficacy in conjunctivitis
* Overlapping investments lead high competition
* Concerns about risk of idiopathic tendonitis / tendon ruptures
* Strong evidence in treating MGD & posterior blepharitis.
* Differentiated bacteria spectrum with good penetration.
* With formal indication of blepharitis Japan.
* Only launched in US, CA, and JP
* High incidence of side effects such as eye irritation and blurred vision.
* Limitation in ointment dosage form
* Chemical instability
* Narrower antibacterial spectrum
* Low drug price and competition
|Marketed antibiotic eyedrops|
• Current leader of the infectious eye disease market
• Broad antibacterial spectrum and good efficacy in conjunctivitis
• Overlapping investments lead high competition
• Concerns about risk of idiopathic tendonitis / tendon ruptures
• Strong evidence in treating MGD & posterior blepharitis.
• Differentiated bacteria spectrum with good penetration.
• With formal indication of blepharitis Japan.
• Only launched in US, CA, and JP
• High incidence of side effects such as eye irritation and blurred vision.
• Limitation in ointment dosage form
• Chemical instability
• Narrower antibacterial spectrum
• Low drug price and competition
|Opportunities for APP13002|
Licensing opportunities ｜APP13002
APP13002 is in IND-enablement stages and is available for licensing or co-development either regionally or globally.
About Anterior Ocular Infections
Ocular infections are common ophthalmic diseases, in deciding on appropriate treatment, both the causative pathogen and the structure(s) affected must be considered.
Symptoms are vary from self-limiting to sight-threatening. Infections occur in different eye structures; presentation and treatment vary accordingly. Infections can occur when tissues of the eye are exposed to pathogens not normally present, when the eye is damaged, allowing pathogens to overcome the natural defenses of the eye, or in immunosuppressed patients where normal flora may become opportunistic.
Bacterial conjunctivitis is a common type of conjunctivitis. It is caused by bacteria that infect the eye through various sources of contamination.
After cataract surgery, there may be a risk of wound infection. If it is not treated timely, there is a potential of damage to vision.
Blepharitis, characterized by eyelid inflammation, is one of the most common eye diseases.
It commonly occurs when tiny oil glands located near the base of the eyelashes become clogged and tends to recur. Blepharitis has a significant impact on ocular comfort and quality of life.
Symptoms of blepharitis include burning, itchiness, gritty feeling in the eyes, contact lens intolerance, photophobia, redness, swelling and crusting of the eyelid margins.
Meibomian Glands Dysfunction
86% of dry eye cases is related to evaporative dry eye, and evaporative dry eye is caused by failure of Meibomian glands producing a strong outer lipid tear layer, resulting in tears that evaporate too quickly.
Meibomian gland dysfunction is 45% to 70% in Asians over 60 years old. According to a global system review*, MGD prevalence in China is >61% while US is 21~60%.
Comparison for China & US market on eye infectious diseases
|Compaison（2019）||Market Size||Bacterial Conjunctivitis||Blepharitis||MGD prevalence||Dry Eye Disease|
|US||15B USD||6M cases||13.2M cases||21~60%||30.6M cases|
|China||2.8B USD||29.4M cases||94.5M cases||>61%||235M cases|
|CN: US Comparison||19% of US||5x of US||7x of US||--||7x of US|
This comparison indicates that the patient populations of such major eye diseases in China were much larger than those in the United States, whereas the size of China’s ophthalmic drug market was only one-fifth of that of the United States in 2019, indicating a strong growth potential of China’s ophthalmic drug market.
- Meibomian gland dysfunction’s Prevalence is 45% to 70% in Asians over 60 years old. According to a global system review*, MGD prevalence in China is >61% while US is 21~60%.
*Global Prevalence of Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis/ OCULAR IMMUNOLOGY AND INFLAMMATION (2020)