FDA approves clobetasol propionate 0.05% for ocular pain, inflammation following surgery

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The approval marks the first new steroid on the ophthalmic market in more than 15 years.

fda approved eyenovia steroid drop for ocular pain and inflammation following surgery - metamorworks

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Updated March 5, 2024 at 8:30 am

The US Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) by Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics. This suspension for the treatment of post-operative inflammation and pain following ocular surgery is the first FDA-approved ophthalmic clobetasol propionate product and first new steroid on the ophthalmic market in over 15 years.1

The corticosteroid, clobetasol propionate ophthalmic suspension 0.05% is derived from Formosa Pharma's proprietary APNT™ nanoparticle formulation platform. In Phase 3 clinical trials, the eyedrops demonstrated rapid and sustained clearance of inflammation and pain relief that was statistically and clinically superior to its matching placebo (P < 0.001). The suspension will provide a convenient and straightforward dosing regimen which consists of twice daily dosing for 14 days without tapering.1

Erick Co, President and CEO of Formosa Pharmaceuticals celebrated the announcement of this approval and noted the dedication of those who worked on this product saying, "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 also highlighted the company’s partnership with Eyenovia, saying, “With FDA approval now secured, we look forward to working with our US commercialization partner, Eyenovia, to reach ophthalmologists and ocular surgery patients, while in parallel working to expand into additional territories and advance our earlier stage pipeline."1

Partnership companies also extended their celebrations, including Eyenovia CEO Michael Rowe. "We congratulate Formosa Pharmaceuticals on the FDA approval of clobetasol propionate ophthalmic suspension 0.05%, the first approved therapeutic to leverage its APNT™ formulation platform, and the first new ophthalmic steroid to enter the US market in over 15 years," he said in a news release.2

"We congratulate Formosa Pharma for the achievements and are extremely pleased with the collaborative opportunity to bring this novel and impressive formulation to the market to benefit millions of patients for the ease of use and rapid recovery and regain of visual acuity after ocular surgery" said AimMax Therapeutics' Founder and Chief Executive Officer, Laurene Wang, PhD.1

Rowe added that the success of clobetasol propionate ophthalmic suspension 0.05% lies in its limited adverse events and efficacy. "The efficacy profile of clobetasol propionate ophthalmic suspension 0.05% is highly desirable, and adverse events were seen in no more than 2% of patients; many of the adverse events may have been caused by the surgical procedure itself. Moreover, we believe its efficacy, safety, and convenient dosing regimen — twice daily without titration versus up to 4 times daily for other post-surgical topical ophthalmic treatment options — will resonate with patients and eye doctors alike for the almost 7 million ocular surgeries that take place in this country every year."2

"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," stated Rowe. "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."1

Additionally, that mid-year launch is to start with an educational campaign focused on cataract surgeons, according to Rowe.2

As Rowe mentions, the market of topical ophthalmic steroids is significant, valued at $1.3 billion dollars, which is fueled by the 7 million ocular surgeries performed every year in the US. In August of 2023, Eyenovia acquired US commercial rights to APP13007 to capitalize on the significant market.3 Formosa Pharmaceuticals, the developer of the steroid, is entitled to million-dollar payments from Eyenovia as well as shares of common stock, and now, with the FDA approval, the NDA will be transferred to Eyenovia.

Similarly, Formosa Pharmaceuticals has released Brazilian commercial rights to Cristália Products Químicos Farmacêuticos LTDA, which includes payments made upfront and upon the completion of developmental and sales milestones.4

References
1. Formosa Pharmaceuticals and AimMax Therapeutics Receive FDA Approval for Clobetasol Propionate Ophthalmic Suspension 0.05%, for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery. Formosa Pharmaceuticals. Published March 4, 2024. Accessed March 4, 2024. https://www.prnewswire.com/news-releases/formosa-pharmaceuticals-and-aimmax-therapeutics-receive-fda-approval-for-clobetasol-propionate-ophthalmic-suspension-0-05-for-the-treatment-of-post-operative-inflammation-and-pain-following-ocular-surgery-302079089.html
2. Eyenovia Congratulates Formosa Pharmaceuticals on FDA Approval of Clobetasol Propionate Ophthalmic Suspension 0.05% for the Treatment of Post-operative Inflammation and Pain Following Ocular Surgery. Eyenovia. News release. Published March 5, 2024. Accessed March 5, 2024.
3. Hutton, D. Eyenovia acquires US commercial rights to APP13007 from Formosa Pharmaceuticals. Modern Retina. August 19, 2023. https://www.modernretina.com/view/eyenovia-acquires-us-commercial-rights-to-app13007-from-formosa-pharmaceuticals
4. Hutton D. Formosa Pharmaceuticals unveils licensing agreement with Cristália for commercialization of APP13007 for treatment of pain and inflammation after ocular surgery. Modern Retina. January 31, 2024.
https://www.modernretina.com/view/formosa-pharmaceuticals-unveils-licensing-agreement-with-crist-lia-for-commercialization-of-app13007-for-treatment-of-pain-and-inflammation-after-ocular-surgery
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