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.,