Formosa Pharma and Eyenovia Announce Initiation of Co-Development of Clobetasol Propionate Ophthalmic Suspension, 0.05%, for the treatment of Acute Dry Eye Disease in United States

Rhea-AI Summary

Formosa Pharmaceuticals and Eyenovia have announced a collaboration to co-develop Clobetasol Propionate Ophthalmic Suspension 0.05% for the short-term relief of dry eye disease in the United States. This agreement expands their existing partnership from February 2023. Clobetasol propionate, a potent steroid, was FDA-approved on March 4, 2024, for reducing inflammation and pain associated with ocular surgeries. The additional acute dry eye indication could benefit millions experiencing flare-ups, as about 80% of dry eye patients suffer from flare-ups. Formosa's proprietary APNT® nanoparticle formulation platform enhances the drug's bioavailability, while Eyenovia's Optejet® dispenser technology offers advanced delivery. This collaboration aims to address a significant market, with approximately 2 million people in the US treated with prescription medications for dry eye.

Positive

• Expansion of existing partnership to co-develop Clobetasol Propionate for dry eye disease
• FDA approval of Clobetasol Propionate for ocular surgery-related inflammation and pain
• Potential to address a large market with 80% of dry eye patients experiencing flare-ups
• Combination of Formosa's APNT® nanoparticle technology and Eyenovia's Optejet® dispenser

Negative

• None.

News Market Reaction – EYEN

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+0.96% News Effect

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TAIPEI, Aug. 7, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the company has signed a non-binding terms agreement with Eyenovia, Inc. ("Eyenovia", NASDAQ: EYEN), whereby the companies will co-develop Clobetasol Propionate Ophthalmic Suspension 0.05% ("clobetasol propionate") for the short-term relief of dry eye disease. 

Both companies will conduct due diligence and work toward a definitive agreement that will include the sharing of development costs and the division of profit upon commercialization. This agreement will effectively expand Eyenovia and Formosa's existing collaboration agreement signed in February 2023 which included the testing of clobetasol propionate in the Optejet^® and a consultation meeting with the FDA to discuss the dry eye indications.

Clobetasol propionate is a potent steroid that was approved in the U.S. by the FDA on March 4, 2024, for the reduction of inflammation and pain associated with the estimated seven million ocular surgeries in the U.S. The additional acute dry eye indication could expand the use of clobetasol among the millions of people who experience flare-ups. According to American Academy of Ophthalmology, about 80% of patients suffering from dry eye experience flare-ups. IQVIA estimates that approximately 2 million people are treated with prescription medications for dry eye in the US.

Clobetasol Propionate Ophthalmic Nanosuspension, 0.05% is the first product developed using Formosa's proprietary APNT^® nanoparticle formulation platform. Formosa's 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.

Erick Co, President and CEO of Formosa Pharma, said, "Formosa Pharma is eager to take the next step in the evolution of our partnership with Eyenovia. We have already proven our respective technologies to be compatible and realizing APNT^® formulations in advanced delivery devices such as Optejet^® is a tremendous opportunity for both companies."

"Clobetasol propionate ophthalmic suspensions has a unique profile that lends itself to exploring its use in dry eye," said Michael Rowe, CEO of Eyenovia. "The drug's efficacy in pain and inflammation relief as well as its low incidence of adverse events could one day be a boon to the millions of dry eye patients who suffer from periodic flare-ups of the disease. The Eyenovia team looks forward to working with our partners at Formosa to move this project forward and ultimately into our Optejet^® dispenser technology."

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^®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, 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 www.formosapharma.com.

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for postsurgical inflammation and pain, and developing the Optejet^® device for use both in connection with its own drug-device therapeutic product for pediatric progressive myopia as well as out-licensing for additional indications. For more information, visit Eyenovia.com.

The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations. 

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SOURCE Formosa Pharmaceuticals Inc.,

FAQ

What is the purpose of the collaboration between Formosa Pharmaceuticals and Eyenovia (EYEN)?

The collaboration aims to co-develop Clobetasol Propionate Ophthalmic Suspension 0.05% for the short-term relief of dry eye disease in the United States.

When was Clobetasol Propionate Ophthalmic Suspension 0.05% approved by the FDA for Eyenovia (EYEN)?

Clobetasol Propionate Ophthalmic Suspension 0.05% was FDA-approved on March 4, 2024, for reducing inflammation and pain associated with ocular surgeries.

What is the market potential for Clobetasol Propionate in dry eye treatment for Eyenovia (EYEN)?

According to IQVIA, approximately 2 million people in the US are treated with prescription medications for dry eye, and about 80% of dry eye patients experience flare-ups, indicating a significant market potential.

What technologies are being combined in this collaboration between Formosa and Eyenovia (EYEN)?

The collaboration combines Formosa's proprietary APNT® nanoparticle formulation platform, which enhances drug bioavailability, with Eyenovia's Optejet® dispenser technology for advanced drug delivery.