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FDA Approves Clobetasol Propionate Eye Drop for Post-Op Inflammation and Pain

FDA Approves Clobetasol Propionate Eye Drop for Post-Op Inflammation and Pain

March 05, 2024

The U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), a novel therapy developed by Formosa Pharmaceuticals in collaboration with AimMax Therapeutics. This treatment is designed for the management of postoperative inflammation and pain following eye surgeries, offering a new hope to patients and healthcare providers alike.

Innovative APNT Nanoparticle Formulation Platform

The product harnesses the power of a super potent corticosteroid, clobetasol propionate, and is the fruit of Formosa Pharma's innovative APNT nanoparticle formulation platform. This marks the debut of an FDA-approved ophthalmic clobetasol propionate solution and introduces the first new steroid to the ophthalmic sector in more than a decade. It promises a simple dosing regimen of twice daily for a fortnight, without the need for tapering.

Results from two pivotal phase 3 clinical trials underscore the therapy's effectiveness, demonstrating rapid and sustained alleviation of inflammation and pain significantly better than a matching placebo (P<0.001).

Comments on the FDA Approval

Erick Co, President and CEO of Formosa Pharmaceuticals, expressed his enthusiasm and gratitude following the FDA's approval: "This approval marks Formosa Pharma's entry into the global marketplace and provides a critical foundation and momentum for continued development, as well as advancement of new endeavors. With immense gratitude, we thank our development colleagues at AimMax Therapeutics for their wisdom and tenacity in guiding the program through to success. Equally, we recognize the tireless efforts of our employees and unwavering support from colleagues in the realization of this corporate milestone," he remarked.

Michael Rowe, CEO of Eyenovia, shared his optimism about the product's market potential: "We believe clobetasol propionate ophthalmic suspension 0.05% will be a very synergistic addition to our commercial product portfolio, and we are honored that Formosa has entrusted Eyenovia with the marketing of this important asset in the United States." He added, "We are already working diligently toward a robust launch of this differentiated and desirable product mid-year, and we believe that, given its more favorable posology and profile compared to other post-surgical steroid options, it has the potential to capture a significant share of an estimated $1.3 billion annual market opportunity."

Looking ahead, Formosa Pharmaceuticals is set to collaborate with Eyenovia, its US commercialization partner, to bring this innovative solution to ophthalmologists and patients undergoing ocular surgery, while also aiming to broaden its reach to additional markets and further its pipeline development.

In August 2023, Eyenovia secured the US commercial rights for this product from Taiwan's Formosa Pharmaceuticals, although specific financial details of the agreement remain undisclosed.

Understanding Postoperative Inflammation and Pain

Postoperative ocular inflammation and pain refer to common complications that can occur after eye surgery. Inflammation is the body's natural response to surgery and can lead to redness, swelling, and discomfort in the eye area. This response is part of the healing process but can cause significant discomfort and potentially affect the outcome of the surgery if not properly managed.

Pain, on the other hand, is a direct sensation often associated with the inflammatory process and the trauma of surgery itself. It can range from mild discomfort to severe pain, depending on the individual's pain threshold, the type of surgery performed, and how the eye responds to the procedure. These conditions are not only uncomfortable but can also interfere with the healing process and the overall success of the surgery.

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