Adalvo announces the signing of an exclusive licensing agreement with Formosa Pharmaceuticals for the commercialisation of Clobetasol Propionate Ophthalmic Suspension, 0.05% in Europe and Brazil.
The product features a patent-protected, patient-friendly regimen of twice-daily dosing over 14 days, with clinical data showing 80% pain resolution by Day 4 and <2% adverse events, supporting its use as a reliable post-operative option.
Developed using Formosa’s proprietary nanoparticle technology, the formulation delivers Clobetasol propionate, a super-potent corticosteroid, in a stable, homogeneous suspension. Approved by the US FDA in March 2024 and already available in the US, the product has earned strong prescriber confidence for its efficacy, tolerability, and ease of use.
Adalvo will lead market access across its licensed territories, leveraging its regulatory and commercial infrastructure to bring this differentiated treatment to healthcare systems in need of advanced anti-inflammatory solutions.
The European ophthalmology market reached $16 billion in 2024, with Germany and the UK as the largest national markets. Cataract surgery remains one of the most frequently performed procedures in EU hospitals, driving demand for effective post-surgical care. The ocular surgery segment is expected to grow to $38 billion by 2032.
"This collaboration reflects Adalvo’s continued commitment to expanding access to novel and differentiated treatments across key therapeutic areas," said Anil Okay, CEO of Adalvo. "We are pleased to partner with Formosa to bring this valuable ophthalmic asset to new markets."
Erick Co, President and CEO of Formosa Pharmaceuticals, added, "Adalvo’s strong presence and expertise in Europe and Brazil make them a natural partner. We look forward to seeing the impact of this product reach a broader patient population."
This agreement strengthens Adalvo’s strategy to grow in hospital-speciality segments through strategic global partnerships.
About Adalvo
Adalvo is a global pharmaceutical company, and one of the leading B2B pharmaceutical companies in Europe, with commercial partnerships in more than 140 countries and over 170+ commercial partners globally. The company’s declared purpose is to make a difference for patients all over the world, driven by our smart collaboration network and commitment to delivering the highest quality differentiated products and services to our partners.
With headquarters in Malta, the company has additional offices in more than 20+ countries. At Adalvo, we know that our partners like to be bigger, better, and smarter in the dynamic pharmaceutical sector. That’s why our approach is unique, customised to our partners, and designed to challenge the status quo: together, this helps our partners achieve their business goals.
We take pride in our ability to help our partners reach their goals – be those increasing revenues or pushing into new markets. While partners are a high priority, Adalvo is also committed to its purpose and mission to accelerate the growth and development of employees and local communities. Adalvo tirelessly strives for excellence in all of its endeavours, driven by a deep-rooted passion for making a difference for partners.
The company’s purpose-driven culture is committed to improving the lives of patients around the world. Our dynamic leadership team brings significant experience and industry know-how to Adalvo, which has helped to establish the company as a reliable global partner.
About Formosa Pharmaceuticals, Inc.
Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company’s proprietary nanoparticle formulation technology (APNT®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in safety, delivery, and penetration to target tissues. For more details about Formosa Pharma and APNT®™, visit www.formosapharma.com.
Disclaimer: The decision may be subject to appeal. Products which are subject to patent protection are currently not offered or made available in countries where patents are in force.