Formosa Pharmaceuticals Pipeline

Inflammation and Pain Treatment after Cataract Surgery |APP13007

APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension) is expected to provide ophthalmologists and ocular surgery patients with compelling, with a compelling, rapid and sustained, and more convenient postoperative anti-inflammatory and pain relief solution.

Target Product Profile |APP13007

Formosa Pharma Ophthalmic Drugs
  • Developed via Formosa Pharma’s proprietary APNT formulation platform.
  • Indication: Treatment of Inflammation and Pain after Ocular Surgery
  • 505(b)(2) pathway – utilizes Clobetasol propionate, which is one of the most potent corticosteroids known in a novel ophthalmology application.
  • Convenient dosing regimen: 1 drop, BID for 2 weeks.
  • Compelling safety data, comparable to Placebo.
  • Convenient low dosing frequency and short duration of treatment; no tapering needed.
  • Strong potential for additional indications

Strategic Partnership|APP13007

Formosa Pharma BD Licensing
  • Formosa Pharma and China Grand Pharmaceutical enter a licensing agreement for APP13007 for China, Hong Kong, and Macau.

  • We are seeking out-licensing partners for the US market.

  • For other regions and territories, we also welcome regional specialty pharmaceutical companies to discuss cooperation opportunities with us.

Unique Positioning and innovation

APP13007’s positioning strategy:

Utilizing potency to increase convenience and compliance.

  • Utilizes one of the most potent corticosteroids 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 our Phase 2 and Phase 3 clinical trials:

    • Efficacy: Suggested superiority over marketed agents.

    • Safety:  No increase in IOP, no difference from placebo.

    • 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

APP13007: Rapid Clearance of Ocular Inflammation (CPN-301 & CPN-302)

APP13007: Rapid and Sustained Ocular Pain Relief

APP13007 shows Convincing Efficacy: Sustained Resolution of Ocular Inflammation and Pain after Cataract Surgery

*Graphs are a comparison of published clinical data; These data are not from a head-to-head clinical study.

Efficacy Summary

  • APP13007 treatment is superior to placebo in achieving both primary efficacy endpoints (i.e. sustained inflammation-free and pain-free).
  • APP13007 treatment produced rapid reduction in ocular inflammation and pain, and rapid regain visual acuity after cataract surgery that is significantly better than placebo.

Safety Summary

  • The safety profile of APP13007 is comparable to that of placebo.
  • Ocular treatment emergent adverse events were those commonly seen after cataract surgery.

Corneal Endothelial Cell Density

  • There was no apparent difference between APP13007 and placebo groups in the corneal endothelial cell densities at Screening or changes from Screening to POD85 visit.

Increased IOP Incidence

  • Adverse events of IOP elevation were infrequent and were managed easily without the need to stop the study drug.

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

Provides a strong patent protection to the asset and differentiation from marketed medicines to ensure enhanced penetration to the target treatment compartment.

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 .

Potent efficacy achieved by low concentration, rapid response, and comparable safety/ tolerability profile

Convenient low dosing frequency and short duration of treatment, and no tapering needed when compared to other marketed therapeutics.

Low concentration of pharmaceutical active ingredient and no milky appearance or precipitate in the formulation.

Reduced potential for side effects; increased patient comfort and compliance.

About Cataract Surgery and Ocular Surgery:

APP13007 for Cataract 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 is surgery to replace an already cloudy lens with intraocular lens.

Due to the improvement of IOLs (intraocular lens) 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 people have undergone cataract surgery.

The number of cataract surgeries in the United States reached 4.6 million cases in 2021.

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.

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%.

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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Development Pipeline

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