Upsher-Smith launched generic cyclosporine ophthalmic emulsion 0.05% in the US for tear production in inflammatory dry eye.
Upsher-Smith Laboratories has launched cyclosporine ophthalmic emulsion 0.05%, a generic version of Restasis, in the US after Bora Pharmaceuticals received FDA approval of an abbreviated new drug application in January 2026, according to a company announcement.1 The product is indicated for increasing tear production in patients whose tear production is presumed to be suppressed because of ocular inflammation associated with keratoconjunctivitis sicca.2
“The launch of cyclosporine ophthalmic emulsion reflects Upsher-Smith's continued momentum in expanding and diversifying its US portfolio,” said Jim Maahs, senior vice president and head of Upsher-Smith Commercial, in the release.1 "This addition strengthens our ophthalmic offerings and reflects our focus on bringing medicines to market that support the evolving needs of our customers, healthcare providers and patients."
For optometrists and ophthalmologists, the launch adds another generic option in a category used for chronic inflammatory dry eye disease (DED), where long-term adherence, tolerability, and cost can influence treatment persistence.
Bora’s product was approved through the FDA’s ANDA pathway and is described by the company as therapeutically equivalent to the reference listed drug, Restasis. The launch includes 0.4-mL single-use vials in 30-count and 60-count packages. The company said the vials should be discarded after each use.1
No new efficacy or safety trial data were reported in the launch announcement. As a generic product, the approval is not based on a new pivotal dry eye efficacy trial against vehicle; rather, ANDA approval generally relies on demonstrating that the proposed generic meets FDA requirements for equivalence to the reference product. Clinicians should therefore interpret this launch primarily as a regulatory and access update, not as evidence of a new clinical advantage over the reference cyclosporine formulation.
Cyclosporine ophthalmic emulsion 0.05% is an immunomodulatory calcineurin inhibitor. Its labeled use is tied to ocular surface inflammation in keratoconjunctivitis sicca, a chronic dry eye condition in which tear film instability, ocular surface inflammation, neurosensory abnormalities, and environmental or systemic factors may contribute to symptoms and signs.2,3 The prescribing information states that increased tear production was not observed in patients who were using topical anti-inflammatory drugs or punctal plugs.2
The original cyclosporine ophthalmic emulsion development program included randomized studies in patients with moderate to severe DED. In those studies, cyclosporine emulsion demonstrated improvement in selected objective measures compared with vehicle, including tear production outcomes in a subset of patients, while ocular burning was a commonly reported adverse event.2,4 The current label identifies ocular burning as the most common adverse reaction, occurring in 17% of patients; other reported reactions include conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance, each reported in 1% to 5% of patients.2
DED remains a common reason for eye care visits and frequently requires stepwise management. Supportive measures may include patient education, environmental modification, lid hygiene when indicated, artificial tears or lubricants, and treatment of meibomian gland dysfunction. For patients with inflammatory disease or persistent symptoms, topical anti-inflammatory therapy, including cyclosporine or other agents, may be considered as part of individualized care.3
From a clinical perspective, the main relevance of this launch is potential expansion of supply and formulary options for a long-used dry eye medication. However, product substitution decisions may still depend on payer coverage, pharmacy availability, patient tolerance of the emulsion, and prior response to therapy. Because dry eye signs and symptoms often correlate imperfectly, clinicians may need to monitor both patient-reported outcomes and objective findings over time rather than assuming interchangeability will translate into identical patient experience.
Remaining questions include real-world persistence with this generic formulation, patient acceptance of single-use vials, and whether additional generic competition changes access for patients who previously faced cost barriers. The prescribing information should guide dosing, contraindications, adverse event counseling, and monitoring.
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