Formosa Pharmaceuticals Pipeline
Inflammation and Pain Treatment after Ocular Surgery ｜APP13007
APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension) is expected to provide ophthalmologists and ocular surgery patients with a compelling, rapid and sustained, and more convenient postoperative anti-inflammatory and pain relief solution.
Target Product Profile ｜APP13007
- Developed via Formosa Pharma’s proprietary APNT™ formulation platform with successful Phase 3 clinical results and approved by US FDA.
- Indication: Treatment of Inflammation and Pain after Ocular Surgery
- 505(b)(2) pathway – utilizes Clobetasol propionate, one of the most potent corticosteroids known, in a novel ophthalmology application.
- APP13007’s TPP is to resolve inflammation and pain following ocular surgery in a rapid and sustained manner with a safety profile comparable to placebo and other marketed corticosteroids for similar indication.
- Compelling safety data, comparable to Placebo.
- Convenient dosing regimen: 1 drop, BID for 2 weeks.
- Convenient posology and short treatment duration; no tapering needed.
- Strong potential for additional indications.
Strategic Partnership｜APP13007
- Formosa Pharma entered Licensing Agreements with:
- Eyenovia for United States and territories
- China Grand Pharmaceutical for China, Hong Kong, and Macau
- CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA for Brazil
- For other countries and regions outside US and China, we welcome specialty pharmaceutical companies to discuss collaboration opportunities with us, learn more.
Unique Positioning and innovation
APP13007 Positioning strategy:
Utilizing Potency And Innovative Formulation Technology To Increase Convenience And Compliance
- Utilizes one of the most potent corticosteroids and innovative APNT™ nanoparticle formulation technology in a novel ophthalmic application.
- Straightforward dosing regimen compared to marketed drugs should provide a convenient, efficacious option for ophthalmologists and patients.
- High quality homogenous nanosuspension ensuring uniformity of dosage.
- According to Phase 2 and Phase 3 clinical trials:
- Efficacy: Exceptionally rapid clearance of inflammation and progression to pain-free. Comparison of clinical results suggest superiority over marketed agents.
- Safety: Well tolerated with a safety profile similar to that of placebo. Incidence of IOP elevation was infrequent and mild, and managed easily without the need to stop the study drug.
- Comfort: No foreign body sensation, feels like water, no irritation.
Phase 3 Summary｜APP13007
Summary Of Phase 3 Trials Of APP13007: CPN-301 & CPN-302 Trial Designs
CPN-301 was a randomized, double-masked trial in the United States of APP13007 versus matching placebo (1:1 ratio) in 378 subjects following cataract surgery. The primary endpoints are complete and sustained resolution of ocular inflammation and pain after cataract surgery. Treatment with an APP13007 eyedrop twice daily for 14 days.
CPN-302 was a randomized, double-masked trial in the United States that evaluated APP13007 versus matching placebo (1:1 ratio) in 370 randomized subjects following cataract surgery. The dosing regimen is the same as CPN-301. Besides the primary endpoints as CPN-301, CPN-302 included a corneal endothelial cell sub-study.
Integrated Phase 3 Clinical Results And Comparison:
Benchmarking against Standards Of Care, APP13007 demonstrates Rapid Clearance Of Ocular Inflammation
Benchmarking against Standards Of Care, APP13007 demonstrates Rapid And Sustained Ocular Pain Relief
Benchmarking against Standards Of Care, APP13007 Demonstrates Convincing EfficacyFor Sustained Resolution Of Ocular Inflammation And Pain
APNT™ nanoparticle formulation｜Brings advantages and Clinical Benefits to APP13007
| Formulation Features | Clinical Benefits and Competitiveness |
|---|---|
|
Developed via Formosa Pharma’s proprietary APNT formulation platform |
Enhances patent protection to the asset and provides differentiation from marketed medicines by ensuring penetration to the target treatment compartments. |
|
Utilizing a nanolized Class I corticosteroid, GRAS grinding media, and excipients. |
Mild manufacturing process with low contamination risk, maintaining stability and potency to the API. Amenable to aseptic filtration. |
|
High-quality homogenous nanosuspension ensuring uniformity of dosage. |
Provides a formulation with outstanding stability, increasing the convenience and ensuring efficacy in each drop.
|
|
Exceptional efficacy achieved in a low concentration formulation with rapid response, and a comparable safety/ tolerability profile |
Convenient low dosing frequency and short duration of treatment, and no tapering needed, compared to other marketed therapeutics. |
|
Low concentration of active pharmaceutical ingredient with no milky appearance or presence of precipitate in the formulation. |
Reduced potential for side effects; increased patient comfort and compliance. |
APNT Nanoparticle Formulation Platform & APP13007 Nanosuspension
APP13007
(Clobetasol Propionate Ophthalmic Nanosuspension 0.05%)
Powered by APNT™ drug delivery technology
About Cataract Surgery and Ocular Surgery:
Cataracts is the disease in which the lens in the eye becomes cloudy.
The main reason is aging.
Cataracts can be found in 100% of people over the age of 80.
Due to the aging of the global baby boomers, the number of cataract patients is increasing rapidly. Currently, there are approximately 75 million cases in the 7MM (United States + EU5 + JP) and at least 54 million cases in China.
Cataract surgery replaces an already cloudy lens with intraocular lens.
Due to the improvement of IOL (intraocular lens) technology in recent years, the surgical experience of ophthalmologists around the world has increased rapidly. In many OECD countries like United States, Japan, France, and Germany, the cataract surgery rate has exceeded 10,000, that is, more than 10,000 people per million population have undergone cataract surgery.
The number of cataract surgeries in the United States reached 4.5 million cases in 2021. In United States, cataract surgeries, typically performed bilaterally, account for about 60% of all ocular surgeries. LASIK, corneal aberration surgeries, advanced glaucoma, retina surgeries, etc. account for the remaining 40%. The annual total ocular surgeries is growing steadily.
The number of cataract surgeries in China in 2019 reached 4.3 million cases, a rapid increase of 15% every year.
Complications of Cataract surgery often occur during after the operation including fragility of the lens capsule, intraocular inflammation, postoperative infection, and increased intraocular pressure.
Among them, the most common is the strong inflammation after the operation, which may cause symptoms such as vision impairment, eye pain and discomfort. Generally, steroid eye drops are used in combination with the treatment to inhibit the inflammation and pain.
Unmet Needs in Ophthalmic Steroids
Compliance:
- Patient adherence to using eye drops is poor, with studies suggesting an overall nonadherence rate of about 30%.
- In a study* in which patients who had cataract surgery on POD 1, 31.5% of patients missed their eye completely and 64% instilled the wrong number of drops.
Source(s): Cataract Refract Surg. 2014;40(11):1857-1861.
Efficacy:
- Recurrent inflammation and pain affect treatment outcome and satisfaction.
- Insufficient efficacy or late response to therapy leads physicians to prescribe treatment over 30 days.
Safety & IOP (Increased intraocular pressure):
- Current SOC and generic steroid eyedrops may have higher incidence of increased intraocular pressure. (extended-release depots & injectables are even higher around 6% ~ 11%)
Comfort & Convenience
- Current SOC steroid eyedrop often induce stinging and foreign body sensation or blurred vision due to API and formulation.
- Patients need to shake the bottle before each use to achieve a homogeneous suspension.
Redefine Patient Experience
APP13007 is proved to the potential for providing Better Efficacy / Better Safety /Better Compliance / Better Comfort compared with marketed products.
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