APP13007 - Clobetasol Propionate Ophthalmic Suspension 0.05% for the treatment of post-operative inflammation and pain following ocular surgery

Model: APP13007

Exhibitor: FORMOSA PHARMACEUTICALS , INC

Booth No: N/A

Characteristic

APP13007 is expected to provide ophthalmologists and patients who receive ocular surgeries with compelling, effective, and more convenient postoperative anti-inflammatory and pain relief solution.
√ Derived from Formosa Pharma’s proprietary APNT nanoparticle formulation technology.
√ Indication: Inflammation and Pain after Ocular Surgery
√ US FDA approved – the first new steroid in over 15 years on the ophthalmic market which utilizes one of the most potent corticosteroids.
√ Dosing regimen: 1 drop, twice per day for 2 weeks.
√ Low dosing frequency and short duration of treatment; no tapering needed.
√ Strong potential for additional indications, e.g., acute dry eye syndrome (DES) and allergic conjunctivitis.
√ Safety profile comparable to placebo, comfort, no foreign body sensation when instilling, and low incidence of increased intraocular pressure (IOP).
√ Partnered with over 10 licensing collaborators covering more than 80 countries:
• North America: USA, Canada, Mexico.
• Asia: Mainland China, South Korea, Middle East, Israel, India, Malaysia, Singapore, Indonesia, Thailand, Philippines, and other South Asian countries.
• Europe: Full coverage of the European Union (EU) and Pan-European regions, including the UK and Switzerland.
• Latin America (LATAM): Brazil, Argentina, Colombia, Chile, and most Central/South American countries.
• Oceania: Australia and New Zealand.
• Africa: Algeria, Kenya, Nigeria, South Africa, etc.
√ Regulatory Status: The product has currently obtained marketing authorization in the U.S. and Canada. Marketing authorization applications (MAA) have been submitted in Saudi Arabia, Switzerland, Chile, and South Africa.