Bora Pharmaceuticals (保瑞) announced on the 22nd that its subsidiary, Upsher-Smith Laboratories (USL), has received US FDA approval for its Abbreviated New Drug Application (ANDA) for Cyclosporine Ophthalmic Emulsion 0.05%, a generic version of AbbVie/Allergan’s Restasis®.

• Market Dynamics: According to IQVIA, the US market for this sterile, single-use immunomodulator was valued at approximately US$1.9 billion for the 12 months ending November 2025.
• Strategic Milestone: USL CCO Jim Maahs noted that this approval marks a pivotal expansion of USL’s ophthalmic portfolio and sets a high-growth trajectory for 2026. USL is currently preparing for an immediate commercial launch, leveraging its established US distribution platform.
• Indication: The drug is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (chronic dry eye).

Resource: 保瑞眼科新藥 獲美藥證