Formosa Pharmaceuticals (6838) announced on the 9th that it has terminated its licensing agreement with Eyenovia, Inc. for APP13007—its new post-operative ophthalmic anti-inflammatory and analgesic drug (clobetasol propionate ophthalmic suspension 0.05%)—and instead entered into an exclusive licensing agreement with Harrow, Inc. Under the new agreement, Harrow will hold exclusive commercialization and distribution rights for APP13007 in the U.S. market.
Formosa noted that Harrow is a Nasdaq-listed U.S. pharmaceutical company focused on the ophthalmology sector, dedicated to the development and commercialization of innovative and branded eye care medicines. Its portfolio includes over 15 FDA-approved prescription and over-the-counter drugs, used for treating a variety of conditions such as dry eye, glaucoma, allergies, infections, and inflammatory eye diseases.
Harrow’s products are widely distributed across the U.S., commonly used by ophthalmologists, hospitals, and ambulatory surgical centers. Its subsidiary, ImprimisRx, is also a leading provider of compounded ophthalmic medications. In 2024, Harrow recorded revenue of USD 199.6 million, representing a 53.3% year-over-year increase from 2023.
According to Formosa, APP13007 is marketed in the U.S. under the FDA-approved brand name BYQLOVI™. The drug is formulated using Formosa’s proprietary APNT nanoparticle technology and contains the highly potent corticosteroid clobetasol propionate as its active ingredient. Approved by the U.S. FDA in 2024, BYQLOVI™ is administered twice daily over a 14-day period. Its simple dosing regimen offers rapid and sustained relief of inflammation and pain.
In a survey of 100 U.S. ophthalmologists, approximately 80% of patients experienced pain relief by the fourth post-operative day, with an adverse event rate of less than 2%. These results were cited as major factors driving physicians’ interest in prescribing APP13007.
Formosa CEO Erick Co stated, “Harrow’s commitment to innovation, accessibility, and physician engagement aligns closely with our mission to deliver unique and clinically impactful therapies. We believe Harrow’s leadership in the U.S. ophthalmic market will ensure the successful adoption of BYQLOVI™ among eye surgeons and specialists, ultimately enhancing post-surgical outcomes for patients.”
Harrow CEO Mark L. Baum commented, “We are thrilled to bring BYQLOVI™, a clinically differentiated ophthalmic steroid, to the U.S. market, where more than 7 million eye surgeries are performed annually. With its superior efficacy, excellent safety profile, and patient-friendly dosing, BYQLOVI™ has the potential to redefine the multibillion-dollar U.S. post-operative eye care landscape.”
APP13007 is Formosa’s lead development asset. Following the initial licensing agreement for the China market in June 2021, Formosa has continued to secure global licensing deals over the past four years. Partners now include Harrow, Apotex, Livzon, Cipla, Adalvo, and others—collectively covering over 80 countries. In addition to U.S. FDA approval, marketing applications have also been filed in Canada, Switzerland, Saudi Arabia, and Taiwan in collaboration with local partners.
Resource: 台新藥眼科藥換合作夥伴 美國市場改授權給Harrow公司
