On the 18th, Formosa Pharmaceuticals announced that it has entered into an exclusive licensing agreement with India-based Cipla Limited for its new drug APP13007, developed for the treatment of inflammation and pain following ocular surgery. Under the terms of the agreement, Cipla will have exclusive commercialization rights for APP13007 in 11 countries, including India, Nepal, Sri Lanka, Bangladesh, Malaysia, Myanmar, Kenya, Nigeria, South Africa, Argentina, and Colombia. This innovative therapy is designed specifically for managing postoperative inflammation and pain in ophthalmic surgery patients.
The active ingredient in APP13007 is clobetasol propionate, an ultra-high-potency corticosteroid, formulated using Formosa Pharmaceuticals’ proprietary APNT® nanoparticle technology. APP13007 is the first ophthalmic clobetasol propionate product to be approved by the U.S. FDA, and it represents the first new steroid introduced to the U.S. ophthalmology market in the past 15 years.
This novel formulation offers a simple and convenient dosing regimen—administered twice daily for 14 days—and delivers rapid and sustained relief from inflammation and pain. In a recent survey of 100 U.S. ophthalmic surgeons, the drug’s ability to provide rapid, complete relief from ocular pain (with approximately 80% of patients reporting complete pain resolution within four days post-surgery) and its low incidence of adverse events (less than 2%) were cited as the primary reasons for choosing to prescribe APP13007.
Dr. Erick Co, President and CEO of Formosa Pharmaceuticals, stated, “We are delighted to partner with Cipla, a globally renowned and highly respected pharmaceutical company. We are grateful for their recognition of APP13007 and their willingness to incorporate it into their extensive portfolio of innovative therapies. We look forward to working together to bring this groundbreaking treatment to ophthalmic surgical patients and to benefit a broader patient population.”
Commenting on the collaboration, Mr. Achin Gupta, Chief Operating Officer of Cipla Global, said, “This partnership with Formosa Pharmaceuticals marks an important milestone for Cipla, as it is our first multi-regional licensing agreement in the field of ophthalmology. It further underscores our commitment to delivering cutting-edge treatments to patients worldwide. With exclusive commercialization rights for APP13007 in 11 countries, we aim to enhance access to this innovative therapy and strengthen our ophthalmic portfolio. We look forward to leveraging Cipla’s strong commercial presence to make a meaningful impact in postoperative eye care.”
Cipla’s ophthalmology division focuses on developing treatments and technologies for glaucoma, dry eye disease, ocular infections, and retinal disorders. The strategic licensing agreement with Formosa Pharmaceuticals includes upfront payments, milestone-based royalties, and other value-based collaboration terms.
Resource: 台新藥與印度Cipla公司就新藥APP13007簽區域合作協議
