Formosa Pharma and Arrotex Ink Deal to Bring Advanced Post-Surgery Eyedrop to ANZ

TAIPEI, Taiwan – February 23, 2026 – Patients recovering from eye surgery in Australia and New Zealand are poised to benefit from a breakthrough treatment, following a major licensing agreement between Taiwan-based Formosa Pharmaceuticals and Australian pharmaceutical giant Arrotex Pharmaceuticals.

The exclusive deal grants Arrotex the rights to commercialize APP13007, an innovative ophthalmic suspension for treating pain and inflammation after ocular surgery. The product, which secured US FDA approval in 2024, leverages a potent corticosteroid with a novel nanoparticle delivery system, promising a more convenient and effective recovery for the region's quarter-million annual cataract surgery patients.

This partnership combines Formosa's cutting-edge biotechnology with Arrotex's unrivaled market dominance in Australia, where it fulfills 50% of the country's total pharmaceutical volume. The agreement, which includes upfront payments, milestones, and royalties, signals a significant step forward in raising the standard of post-operative ophthalmic care in the region.

A New Paradigm in Post-Surgical Eye Care

At the heart of the agreement is APP13007, a topical eyedrop that represents a significant evolution in ophthalmic corticosteroids. Its active ingredient is clobetasol propionate, a "superpotent" steroid traditionally used in dermatology. Its application in ophthalmology was made possible by Formosa's proprietary APNT® (Activated-Pharmaceutical-Nanoparticle-Technology) platform.

This advanced formulation technology creates uniform nanoparticles that enhance the drug's solubility and ability to penetrate ocular tissues. The result is a highly effective treatment that was the first new ophthalmic steroid to enter the US market in over 15 years.

For patients, the most tangible benefit may be its simplified dosing regimen. APP13007 is administered just twice daily for 14 days without the need for a tapering schedule—a stark contrast to many existing treatments that can require applications up to four times a day along with a gradual reduction in dosage. This convenience is expected to significantly improve patient compliance, a critical factor in successful post-operative outcomes.

Clinical data from US trials underscores its efficacy. A survey of ophthalmic surgeons highlighted the drug's rapid resolution of pain, with approximately 80% of patients reporting they were pain-free just four days after surgery. Furthermore, the treatment demonstrated a strong safety profile, with a low incidence of adverse events (<2%) and, crucially, no clinically significant increases in intraocular pressure (IOP)—a common and potentially serious side effect associated with other steroid eye drops.

A Strategic Partnership to Unlock Market Access

The collaboration is a textbook example of strategic synergy. Formosa Pharmaceuticals, a clinical-stage biotech, has developed a world-class product validated by the FDA. However, entering new international markets requires a partner with deep local expertise and infrastructure. This is where Arrotex Pharmaceuticals provides an unparalleled advantage.

As 'Australia's Medicines Company,' Arrotex is a dominant force in the region's pharmaceutical landscape. Formed from the 2019 merger of Arrow Pharmaceuticals and Apotex Australia, the company has an extensive distribution network that services pharmacies and hospitals nationwide, fulfilling one in every two scripts on Australia's Pharmaceutical Benefits Scheme (PBS).

Erick Co, President and CEO of Formosa Pharmaceuticals, commented on the strategic fit. "We are grateful Arrotex has chosen to partner with Formosa Pharma, recognizing APP13007 as a worthy addition to their vast and innovative portfolio of therapeutics," he stated. "Arrotex's unrivaled sales distribution force and pharmacy access will ensure APP13007's availability to patients recovering from ocular surgery."

For Arrotex, the deal aligns with its goal of expanding its specialist care portfolio. Matt Zeller, CEO of Arrotex Pharmaceuticals, emphasized the company's commitment to innovation. "This agreement with Formosa Pharmaceuticals strengthens our expanding portfolio in specialist care and reinforces our ambition to deliver meaningful innovation to patients," Zeller said. "As Australia's partner in health, we will leverage our national ophthalmology footprint and unique infrastructure to ensure APP13007 reaches the people who need it most across the broad ecosystem."

Navigating the Path to Patients in Australia and New Zealand

With the licensing agreement in place, the next steps involve navigating the regulatory and reimbursement pathways in Australia and New Zealand. The product will need to be approved by Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe. Given its prior approval by the US FDA, the process may be streamlined, particularly in New Zealand, which offers a "consent by verification" pathway for medicines approved by recognized overseas regulators.

The critical hurdle for widespread adoption will be securing reimbursement. In Australia, this means a successful submission to the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the PBS. In New Zealand, funding is determined by PHARMAC. Arrotex's extensive experience and success in navigating these complex systems will be invaluable.

The target market is substantial and growing. An estimated 250,000 cataract surgeries are performed annually across Australia and New Zealand. With an aging population, this number is projected to increase, driving demand for more effective and patient-friendly post-operative treatments like APP13007.

This agreement is the latest in a series of global partnerships for Formosa, which has already secured licensing deals for APP13007 in the United States, Canada, Europe, China, and the Middle East. The addition of Australia and New Zealand via a market-leading partner like Arrotex further solidifies the global footprint of this innovative therapy and promises a higher standard of care for patients recovering from vision-restoring surgery.