Saptalis launches cyclosporine emulsion 0.05% for dry eye

Mechanism and dosing

According to a new announcement from Saptalis Pharmaceuticals LLC, the company has commercially launched cyclosporine ophthalmic emulsion 0.05%, a preservative-free, single-use formulation indicated to increase tear production in patients with inflammation-associated tear deficiency.¹ Available in 30- and 60-count vial configurations, the product expands OD prescribing options for a condition affecting millions of patients worldwide.¹

Cyclosporine ophthalmic emulsion 0.05% has anchored the anti-inflammatory arm of dry eye management since the original branded formulation, Restasis (cyclosporine ophthalmic emulsion; Allergan/AbbVie), received FDA approval in 2003 as the first prescription agent indicated to modify the underlying inflammatory process rather than provide palliative relief only.² Generic single-use vial versions of the formulation represent a segment with estimated annual U.S. sales of approximately $2 billion, underscoring sustained clinical demand and broad patient use.³

Cyclosporine acts as a topical calcineurin inhibitor: applied to the ocular surface, it penetrates lacrimal gland epithelial cells and T lymphocytes, where it binds cyclophilin A.⁴ The resulting complex blocks calcineurin phosphatase activity, suppressing IL-2 transcription and downstream T-cell activation and cytokine release.⁴ This cascade reduces ocular surface inflammation, stabilizes the tear film, and supports conjunctival goblet cell density.⁴ Dosing follows the established regimen of one drop instilled twice daily in each eye, approximately 12 hours apart.² Randomized controlled trials have consistently shown cyclosporine emulsion 0.05% outperforms vehicle on objective endpoints including Schirmer scores and corneal fluorescein staining, though full efficacy may require six months or more of continuous therapy.⁴

Safety and OD use

The safety profile of cyclosporine ophthalmic emulsion 0.05% is well characterized across decades of clinical use. The most common adverse reaction is ocular burning, reported transiently following instillation; no increase in bacterial or fungal ocular infections has been associated with the formulation.³ Increased tear production has not been observed in patients concurrently using topical anti-inflammatory agents or punctal plugs, an important consideration when evaluating candidates.² Contact lens wearers should remove lenses prior to instillation and may reinsert them 15 minutes after dosing.²

The preservative-free, single-use vial format addresses a practical concern in long-term dry eye management: cumulative preservative exposure on an already compromised ocular surface. For ODs managing patients with moderate to severe aqueous-deficient dry eye or those who have not responded adequately to lubricant therapy alone, the Saptalis formulation provides a commercially available generic option. Patient counseling should include realistic timelines for response, as the anti-inflammatory mechanism requires sustained use before objective and subjective improvements typically emerge.⁴

"With these launches, we continue to grow our generic business segment with US-based manufacturing, while maintaining our primary focus on advancing our pipeline of innovative branded therapies addressing unmet medical needs," Polireddy Dondeti, President and CEO of Saptalis Pharmaceuticals LLC, said in a news release.¹

The Hauppauge, New York-based company manufactures the formulation at a US facility compliant with FDA current Good Manufacturing Practice standards.¹ ODs can prescribe cyclosporine ophthalmic emulsion 0.05% directly within their scope; no referral or co-management is required for initiation or monitoring. Full prescribing information is available at saptalis.com.

References:

1. Saptalis Pharmaceuticals LLC. Saptalis Pharmaceuticals launches cyclosporine ophthalmic emulsion 0.05% and expands product portfolio. Business Wire. 2025. https://www.businesswire.com

2. Cyclosporine ophthalmic emulsion prescribing information. Drugs.com. Accessed June 2026. https://www.drugs.com/pro/cyclosporine-ophthalmic-emulsion.html

3. Amneal Pharmaceuticals Inc. Amneal announces U.S. FDA approval of cyclosporine ophthalmic emulsion 0.05%. Globe Newswire. December 1, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-U-S--FDA-Approval-of-Cyclosporine-Ophthalmic-Emulsion-0-05/default.aspx

4. Ge S, Chen X, Wu L, et al. Cyclosporine A in the treatment of dry eye disease: a narrative review. Front Ophthalmol. 2025;5:1700163. https://pmc.ncbi.nlm.nih.gov/articles/PMC12672223/