Tuesday, April 16, 2024

First FDA-Approved Ophthalmic Care Formulation of Clobetasol Propionate Revolutionizes Eye Care

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A significant advancement in ophthalmic care has been achieved with the introduction of the first FDA-approved ophthalmic formulation of clobetasol propionate. This is the first new steroid in the ophthalmic market in over a decade and a half. The approved formulation simplifies the dosing regimen, requiring administration only twice a day for 14 days, eliminating the need for tapering.

The ophthalmic suspension demonstrated in two Phase III clinical trials a quick and lasting clearance of inflammation and pain relief, with results that were statistically and clinically superior to a matching placebo. The new eyedrop is set to enter a market valued at $1.3bn, driven by nearly seven million ocular surgeries performed per year in the US.

Formosa Pharmaceuticals Launches into Global Market with FDA-Approved Ophthalmic Care Suspension

Formosa, focusing strategically on ophthalmology and oncology, used its APNT nanoparticle formulation platform to develop the newly approved clobetasol propionate ophthalmic suspension 0.05%. This platform enhances the dissolution and bioavailability of active pharmaceutical ingredients (APIs), which are essential for topical, oral, and inhaler drug delivery.

According to Erick Co, president and CEO of Formosa Pharmaceuticals, this approval marks the company’s entry into the global marketplace and provides a critical foundation and momentum for continued development and advancement of new endeavors. With FDA approval now secured, they look forward to working with their US commercialization partner, Eyenovia, to reach ophthalmologists and ocular surgery patients. They are also planning to expand into additional territories and advance their earlier stage pipeline.

Ophthalmic Care

Eyenovia Secures US Marketing Rights from Formosa for Groundbreaking Ophthalmic Nanosuspension

In August of the previous year, Formosa signed a licensing agreement granting sole US rights for marketing APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) to Eyenovia. As part of the deal, Formosa received upfront as well as development and sales-based milestone payments totaling $86m along with other agreement considerations.

The introduction of the first FDA-approved ophthalmic formulation of clobetasol propionate marks a significant advancement in ophthalmic care. Offering a simplified dosing regimen and promising results from clinical trials, this new product is poised to make a significant impact in a market driven by millions of ocular surgeries per year in the US.

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