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

Rhea-AI Summary

Formosa Pharmaceuticals and AimMax Therapeutics receive FDA approval for clobetasol propionate ophthalmic suspension 0.05%, a novel steroid for post-operative ocular surgery. The product shows superior results in Phase 3 trials, targeting a $1.3 billion market.

Insights

Pharmaceutical Industry Analyst

The FDA approval of clobetasol propionate ophthalmic suspension 0.05% marks a significant milestone for Formosa Pharmaceuticals and AimMax Therapeutics, signaling a potential shift in the post-operative ocular treatment landscape. The product's entry into the ophthalmic steroid market, valued at $1.3 billion, introduces a new competitor into a space that has not seen a novel steroid introduction in over a decade and a half.

The proprietary APNT™ nanoparticle formulation platform could represent a technological advantage, potentially offering enhanced delivery and efficacy. The superior clinical outcomes demonstrated in Phase 3 trials, notably the rapid and sustained clearance of inflammation and pain relief, position the product as a strong contender against existing treatments. This could lead to a rapid adoption curve and market penetration, potentially reshaping market dynamics and influencing the stock performance of involved companies.

Medical Research Analyst

From a medical standpoint, the approval of a new ophthalmic steroid with a 'super potent' corticosteroid and a convenient dosing regimen (twice daily for 14 days without tapering) addresses a significant need for post-operative care in ocular surgery. The impact of this new treatment option on patient outcomes cannot be overstated, as the ease of use and the elimination of a tapering schedule can lead to better adherence and, subsequently, better recovery outcomes.

Furthermore, the statistically significant results from the clinical trials (p<0.001) not only underscore the efficacy of the drug but also suggest a potential for setting a new standard of care in post-operative inflammation and pain management. This could lead to a shift in prescribing habits and an increase in market share for Formosa Pharmaceuticals and its partners.

Market Research Analyst

The ophthalmic steroid market serves a substantial and consistent patient population, with an estimated seven million ocular surgeries performed annually in the United States alone. The introduction of clobetasol propionate ophthalmic suspension 0.05% could disrupt the current market, offering a new option to ophthalmologists and patients. The strategic partnership with Eyenovia for U.S. commercialization is particularly noteworthy, as it leverages Eyenovia's expertise in the field to maximize the product's market reach and penetration.

Given the product's favorable posology and clinical profile, it is poised to capture a significant share of the market. The mid-year launch timeline allows for anticipation build-up among healthcare providers and patients, potentially accelerating uptake upon release. The market response to this launch could be a significant indicator of the product's future trajectory and its impact on Formosa Pharmaceuticals' financial performance.

TAIPEI, March 4, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals (6838.TWO) and AimMax Therapeutics (United States) announced today that the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-operative inflammation and pain following ocular surgery.  

Utilizing a super potent corticosteroid, clobetasol propionate ophthalmic suspension 0.05% is derived from Formosa Pharma's proprietary APNT™ nanoparticle formulation platform.  This innovative formulation represents the first FDA-approved ophthalmic clobetasol propionate product and the first new steroid in over 15 years on the ophthalmic market, offering patients a convenient and straightforward dosing regimen (twice daily for 14 days without tapering).  Two Phase 3 clinical trials demonstrated rapid and sustained clearance of inflammation and pain relief that was statistically and clinically superior to its matching placebo (p<0.001). This novel eyedrop enters a $1.3 billion dollar market for topical ophthalmic steroids and steroid combinations, driven by an estimated seven million ocular surgeries performed annually in the United States.

"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," said Erick Co, President and CEO of Formosa Pharmaceuticals. With FDA approval now secured, we look forward to working with our U.S. commercialization partner, Eyenovia, Inc., to reach ophthalmologists and ocular surgery patients, while in parallel working to expand into additional territories and advance our earlier stage pipeline."

"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, Ph.D.

"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 Michael Rowe, Chief Executive Officer of Eyenovia. "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." 

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TWO) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology.  The company's proprietary nanoparticle formulation technology (APNT™) improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration.  Subsequent formulations have high purity, uniformity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in delivery and penetration to target tissues.  For more details about Formosa Pharma and APNT™, visit Formosapharma.com.

About AimMax Therapeutics, Inc.

AimMax Therapeutics, Inc., engages in the research and development of pharmaceuticals at various stages of development through its discovery or by co-development with strategic partners.  The company's R&D strengths derive from extensive and synergistic experience in basic and nonclinical research, translational medicine, clinical trial design, and regulatory and commercial strategy.

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its proprietary Optejet dispensing platform. Eyenovia is currently focused on the commercialization of Mydcombi™ (tropicamide+phenylephrine ophthalmic spray) for mydriasis, as well as clobetasol propionate ophthalmic suspension 0.05% (APP13007) for pain and inflammation post ocular surgery. Eyenovia is also advancing late-stage development of medications in the Optejet device, including MicroPine for myopia progression (partnered with Arctic Vision in China and South Korea), and Apersure for presbyopia. For more information, visit Eyenovia.com.

 

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SOURCE Formosa Pharmaceuticals

FAQ

What is the FDA-approved product for post-operative inflammation and pain following ocular surgery by Formosa Pharmaceuticals and AimMax Therapeutics?

The FDA has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for this purpose.

What is the unique feature of clobetasol propionate ophthalmic suspension 0.05%?

It is derived from Formosa Pharma's proprietary APNT™ nanoparticle formulation platform.

How does clobetasol propionate ophthalmic suspension 0.05% stand out in the market?

It is the first FDA-approved ophthalmic clobetasol propionate product and the first new steroid in over 15 years in the ophthalmic market.

What were the results of the Phase 3 clinical trials for clobetasol propionate ophthalmic suspension 0.05%?

The trials showed rapid and sustained clearance of inflammation and pain relief superior to its placebo (p<0.001).

Who is the U.S. commercialization partner for Formosa Pharmaceuticals' product?

Eyenovia, Inc. is the commercialization partner for the product in the United States.