Formosa Pharmaceuticals Makes First Shipment of APP13007 (Clobetasol Propionate Ophthalmic Suspension, 0.05%) to the United States for Commercialization

Rhea-AI Summary

Formosa Pharmaceuticals (6838.TW) has made its first shipment of APP13007 (Clobetasol Propionate Ophthalmic Suspension, 0.05%) to the United States for commercialization. The drug, developed using Formosa's APNT® nanotechnology platform, is the first FDA-approved ophthalmic use of the super-potent corticosteroid, clobetasol propionate. Eyenovia (NASDAQ: EYEN), Formosa's U.S. partner, is set to begin commercialization in late September.

APP13007 offers a more convenient dosing regimen with twice-daily administration, compared to other treatments requiring up to four doses per day. The ophthalmic steroid market is valued at $1.3 billion, with nearly 7 million ophthalmic surgeries performed annually in the U.S. Formosa is also preparing for regulatory submissions in other regions to expand its international market presence.

Positive

• First shipment of APP13007 to the U.S. market, indicating progress towards commercialization
• APP13007 is the first FDA-approved ophthalmic use of clobetasol propionate, a super-potent corticosteroid
• More convenient dosing regimen (twice-daily) compared to competitors (up to four times daily)
• Large market potential with 7 million annual ophthalmic surgeries in the U.S. and a $1.3 billion ophthalmic steroid market
• Expansion plans for international markets through regulatory submissions in other regions

Negative

• None.

Pharmaceutical Industry Analyst

The first shipment of APP13007 marks a significant milestone for Formosa Pharmaceuticals. This novel ophthalmic drug addresses a substantial market, with the U.S. ophthalmic steroid market valued at $1.3 billion. The drug's unique selling points include:

• First FDA-approved ophthalmic use of clobetasol propionate
• Convenient twice-daily dosing compared to competitors' four times daily
• Potential for improved efficacy and cost-effectiveness

These factors position APP13007 favorably in a competitive landscape. The imminent commercialization through Eyenovia could drive near-term revenue growth for Formosa. However, market penetration and adoption rates remain uncertain, warranting close monitoring of initial sales figures and physician feedback.

Ophthalmology Specialist

APP13007 represents a significant advancement in post-operative ophthalmic care. The use of clobetasol propionate, a super-potent corticosteroid, could potentially offer superior anti-inflammatory effects compared to existing options. The reduced dosing frequency (twice daily vs. four times daily) may improve patient compliance, a important factor in post-surgical outcomes. However, it's important to note that while efficacy and cost were identified as key factors by surgeons, safety profiles and long-term outcomes will be critical in determining widespread adoption. The ophthalmic community will likely closely monitor initial real-world data to assess APP13007's performance against established treatments.

Market Research Analyst

The launch of APP13007 taps into a substantial market opportunity, with nearly 7 million annual ophthalmic surgeries in the U.S. alone. Formosa's partnership with Eyenovia (NASDAQ: EYEN) for U.S. distribution leverages established market channels, potentially accelerating adoption. The global expansion strategy, evidenced by ongoing regulatory preparations in other regions, suggests a phased approach to market penetration. This could lead to incremental revenue streams over time. Investors should watch for:

• Initial U.S. sales figures and market share gains
• Progress in regulatory submissions in other key markets
• Any shifts in prescribing patterns among ophthalmic surgeons

These factors will be important in assessing the long-term commercial viability and growth potential of APP13007.

TAIPEI, Sept. 9, 2024 /PRNewswire/ -- Formosa Pharmaceuticals, Inc. (hereinafter referred to as "Formosa Pharma," 6838.TW) announced the successful first shipment to the United States of its new ophthalmic drug, Clobetasol Propionate Ophthalmic Suspension, 0.05% (APP13007), manufactured by Bora Pharmaceuticals Ophthalmic (hereinafter referred to as "Bora," 6472.TW). Formosa Pharma's U.S. partner, Eyenovia, Inc. (NASDAQ: EYEN), has initiated the pre-launch activities for APP13007 and is expected to begin commercialization in late September.

APP13007, developed through Formosa Pharma's proprietary APNT^® nanotechnology platform, is the first drug approved by the U.S. FDA for ophthalmic use utilizing the super-potent corticosteroid, clobetasol propionate. Almost 7 million ophthalmic surgeries are performed annually in the U.S., and the ophthalmic steroid and steroid-combination drug market is valued at USD $1.3 billion. According to a recent survey conducted by Eyenovia of 100 U.S. ophthalmic surgeons, efficacy and cost were identified as the most important factors when choosing a treatment for postoperative inflammation and pain. APP13007 offers a more convenient dosing regimen with its proven efficacy, requiring only twice-daily administration compared to other treatments that require up to four doses per day.

Having recently obtained the Drug Export License from Taiwan's Food and Drug Administration (TFDA) in late August, Formosa Pharma has coordinated its first US shipment, a milestone advancement toward global commercialization.

Dr. Erick Co, President & CEO of Formosa Pharma, said, "This first shipment to Eyenovia for the much-anticipated commercial U.S. launch is an exclamation point on our development of APP13007.  We thank all our partners for making this journey with us and are eager to provide this formidable therapy to ocular surgery patients worldwide.  We look forward to creating continued value for our stakeholders and shareholders."

In addition to meeting demands for the U.S. market, Formosa Pharma is actively working with partners in other regions to prepare for regulatory submissions for APP13007, aiming to supply various international markets in the future.

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TW) 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.

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SOURCE Formosa Pharmaceuticals Inc.,

FAQ

When will Eyenovia (EYEN) begin commercialization of APP13007 in the United States?

According to the press release, Eyenovia (EYEN) is expected to begin commercialization of APP13007 in late September 2024.

What is the dosing regimen for Formosa Pharmaceuticals' APP13007 compared to other treatments?

APP13007 offers a more convenient dosing regimen, requiring only twice-daily administration, compared to other treatments that may require up to four doses per day.

What is the market size for ophthalmic steroid and steroid-combination drugs in the U.S.?

The ophthalmic steroid and steroid-combination drug market in the U.S. is valued at USD $1.3 billion, according to the press release.

How many ophthalmic surgeries are performed annually in the United States?

Almost 7 million ophthalmic surgeries are performed annually in the United States, as stated in the press release.