AimMax Therapeutics, Inc.

Besides marketing Formosa’s drug in the U.S., Eyenovia is exploring further development of the clobetasol propionate formulation in its Optejet dispenser. Taiwan’s Formosa Pharmaceuticals has gained an FDA approval for a reformulation of a decades-old corticosteroid.  Monday, the U.S. FDA granted approval to Formosa and AimMax Therapeutics’ clobetasol propionate ophthalmic suspension 0.05% to treat post-operative inflammation and pain following eye surgery. The drug utilizes a potent corticosteroid modified with Formosa’s APNT nanoparticle formulation platform, which makes it possible to administer to the eye via a twice-daily dosing regimen, the companies said in a release. Clobestasol propionate is a prednisolone derivative that snared its first FDA approval on Dec. 27, 1985. As a topical steroid, the drug is used to treat multiple skin conditions such as eczema, psoriasis, allergies and rash. The FDA based its recent approval on two phase 3 trials, in which Formosa’s nanosuspension steroid provided “rapid and sustained” clearance of inflammation and pain relief after eye surgery versus placebo, the company explained in its release. Formosa’s eye-drop is set to enter a $1.3 billion market for topical ophthalmic steroids, the company said. In order to breach the market, Formosa has tapped commercial stage eyecare specialist Eyenovia in the U.S. In a separate release, Eyenovia said it plans to launch in the U.S. “as soon as this summer,” leveraging the same salesforce it uses to market its pupillary dilation spray Mydcombi. Mydcombi, a fixed-dose combination of two popular dilating meds tropicamide and phenylephrine, was approved in May of 2023. The drug represents the first approved product made with Eyenovia’s Optejet device system. Unlike traditional eye droppers where patients need to tilt their heads and fight the urge to avoid a droplet, Optejet dispenses its drug in microdoses horizontally as a spray with the push of a button. As for the newly approved steroid nanosuspension, Eyenovia picked up the U.S. commercial rights to Formosa’s product last August. The eyecare specialist paid $2 million upfront to Formosa, split evenly between cash and stock, and also pledged up to $4 million in development milestones and $80 million in sales milestones, according to a recent securities filing. Besides marketing Formosa’s drug, Eyenovia is exploring further development of the clobetasol propionate formulation in its Optejet dispenser as a potential treatment for dry eye. Elsewhere, Formosa has been busy striking separate commercialization pacts in other countries, too. In late January, the company enlisted Cristália Produtos Químicos Farmacêuticos to help bring the product to the Brazilian market.

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. SOURCE Formosa Pharmaceuticals

Phalguni Deswal @Phalguni_GD Formosa will receive up to $86m, in upfront and milestone-based payments. Image Credit: megaflopp / Shutterstock. Eyenovia has acquired the exclusive licencing and commercialisation rights for APP13007 (clobetasol steroid) in the US, from the Taiwan-based Formosa Pharmaceuticals for $86m. The deal builds upon the existing partnership between the two companies to develop new eye therapies signed earlier this year. Recommended Reports Reports LOA and PTSR Model - Clobetasol Propionate in Ocular Pain (Eye Pain) GlobalData Reports LOA and PTSR Model - Tafenoquine Succinate in Candidiasis GlobalData View all Companies Intelligence Eyenovia Inc AimMax Therapeutics Inc Formosa View all APP13007 is a 0.05% clobetasol propionate ophthalmic nanosuspension developed using Formosa’s proprietary APNT nanoparticle formulation platform by Formosa and AimMax Therapeutics . It is a twice-daily topical corticosteroid that reduces pain and inflammation following eye surgery. APP13007 is currently under review by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date set for 4 March 2024. Following the FDA approval and transfer of the New Drug Application (NDA) to Eyenovia, Formosa will be eligible to receive a single-digit million-dollar payment, as per Eyenovia’s 16 August press release . Formosa will receive additional milestone-based payments totalling $86m, including the upfront payment. Eyenovia plans to incorporate the drug with its drug delivery device Optejet for a drug-device therapeutic , with the company’s CEO Michael Rowe stating: “We will also be discussing with the FDA the opportunity to develop novel clobetasol formulations as a late-stage asset for use with the Optejet as a potential treatment for dry eye, a market estimated to be worth over $3.6 billion.” Earlier this year, Eyenovia’s MydCombi (tropicamide and phenylephrine hydrochloride) was the first eye spray approved by the US FDA for pupil dilation . The spray can be used for pupillary dilation in multiple conditions including cataracts and other eye surgeries. Eyenovia plans to market both products for surgical use. “Alongside our mydriasis product, MydCombi, we can bring additional value to ophthalmic surgeons and their patients through the use of MydCombi for pre-operative dilation and APP13007 post-operatively, both supported by a single dedicated sales force,” said Rowe.