FDA approves Eyenovia’s APP13007 for relief of pain, inflammation after surgery

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Formosa Pharmaceuticals and AimMax therapeutics announced the FDA has approved Eyenovia’s APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) eye drops for the relief of pain and inflammation following ocular surgery.

Eyenovia acquired U.S. commercial rights of the drug last August from Formosa.

The treatment, which contains potent topical steroid clobetasol propionate, is typically used to treat skin conditions such as eczema and psoriasis.

According to a news release, the companies noted that through 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).¹

According to the news release, 2 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 market for topical ophthalmic steroids and steroid combinations, driven by an estimated seven million ocular surgeries performed annually in the United States.

Erick Co, president and CEO of Formosa Pharmaceuticals, pointed out the 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,” Co said in the news release. “Equally, we recognize the tireless efforts of our employees and unwavering support from colleagues in the realization of this corporate milestone. 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."

AimMax Therapeutics' founder and CEO, Laurene Wang, PhD, lauded Formosa for the milestone.

"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" Wang said.

Michael Rowe, CEO of Eyenovia, noted the eye drops will be a key addition to the company’s portfolio.

"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," Rowe said in the news release. "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."

Neda Shamie, MD, from the Maloney-Shamie Vision Institute in Los Angeles, and co-chief medical editor of Ophthalmology Times, pointed out that Eyenovia's APP13007, a clobetasol propionate ophthalmic nanosuspension at 0.05% concentration, offers a significant advancement in treating post-operative inflammation and pain in ophthalmic patients.

“Utilizing Eyenovia's microdosing technology for precise delivery, APP13007 aims to enhance therapeutic outcomes, reduce side effects, and improve patient compliance compared to traditional eye drop methods,” she said. “This innovation represents a promising development for ophthalmologists seeking more effective and patient-friendly options for managing post-surgical complications and experience. Its potential impact hinges on clinical effectiveness, ease of adoption by healthcare professionals, and accessibility for patients, marking a step forward in post-operative eye care.”

Formosa’s proprietary APNT technology, which has been used in the development of clobetasol propionate ophthalmic suspension to reduce the particle size of the active pharmaceutical ingredient, is thought to provide many benefits, including high uniformity and purity, improved stability, improved dispersion properties and greater bioavailability.

“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,” Rowe said in a separate news release. “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, Rowe said the company believes its efficacy, safety, and convenient dosing regimen – twice daily without titration versus up to four 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.

“In addition to its many favorable clinical attributes, clobetasol propionate ophthalmic suspension 0.05% fits perfectly within our commercial strategy by allowing us to leverage our sales and distribution infrastructure. We are working towards a robust launch mid-year starting with an educational campaign focused on cataract surgeons,” Rowe concluded.

Longer term, Eyenovia is exploring further development of the product in the Optejet dispenser as a potential treatment for dry eye, which the Company estimates to be a $3.6 billion market.

Eyenovia said in its news release it will provide a further update on this and other recent developments, including timing for approval of its tradename for this product, during its fourth quarter and full-year 2023 results conference call in mid-March.

Background

In August 2023, Eyenovia announced it had reached an agreement with Taiwan-based Formosa Pharmaceuticals to acquire the exclusive US rights to distribute and sell APP13007.²

According to the company, clobetasol is a potent steroid not yet available in ophthalmology that, if approved, could have an advantageous profile in dosing frequency (2x/day versus 4x/day for most other post-surgical eye drops) and tolerability while reducing the inflammation and pain associated with ocular surgery.

APP13007, according to the company, is the first product developed using Formosa’s proprietary APNT nanoparticle formulation platform. The company noted that its APNT platform reduces an active pharmaceutical ingredient’s particle size with high uniformity and purity, thereby allowing penetration to relevant compartments in the eye, and ultimately enhancing bioavailability.

Under terms of Eyenovia’s agreement with Formosa, the company is slated to make single-digit, million-dollar payments to Formosa in cash and shares of Eyenovia common stock upon the signing of the deal, upon FDA approval of APP13007 and the transfer of the NDA to Eyenovia, and following the first commercial sale of APP13007.²

The company also noted in its news release that Formosa will be eligible for payments related to the attainment of sales milestones by Eyenovia.

The company also noted in its news release it is estimated that there are more than 7 million ocular surgeries in the US each year with topical ocular steroids and steroid combinations currently totaling $1.3 billion in sales.²

Reference

1. Pharmaceuticals F. 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. www.prnewswire.com. Accessed March 5, 2024.

2. 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