Taipei, Taiwan, January 22, 2026 – Bora Pharmaceuticals Co., Ltd. (“Bora” or “the Company”) announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s cyclosporine ophthalmic emulsion 0.05%, a sterile, single-use formulation supplied in vials. The product is the generic equivalent of RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%, a registered trademark of Allergan, and will be marketed by Bora’s subsidiary Upsher-Smith.
“The FDA approval of cyclosporine ophthalmic emulsion marks an important step in the continued expansion of Upsher-Smith’s U.S. ophthalmology portfolio and a strong start to 2026 as we refill our product pipeline.,” said Jim Maahs, Senior Vice President and Head of Commercial at Upsher-Smith Laboratories. “With a proven commercialization platform, we are well positioned to execute efficiently and drive long-term value for our partners and stakeholders.”
Cyclosporine ophthalmic emulsion 0.05% is a topical immunomodulator indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
According to IQVIA® U.S. annual sales for cyclosporine ophthalmic emulsion 0.05% in sterile, preservative-free single-use vials for the 12 months ended September 2025 were approximately $1.9 billion.