Adalvo Inks Licensing Deal with Formosa Pharmaceuticals for Novel Ophthalmic Steroid in Europe and Brazil

29 May 2025 | Thursday | News


Twice-daily Clobetasol propionate suspension, backed by US FDA approval and rapid pain resolution data, to expand access in major post-surgical ophthalmic markets through Adalvo’s commercial network.
Image Source : Public Domain

Image Source : Public Domain

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.

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