FDA-Approved Drugs

This is a list of prescription drugs approved by the FDA for Dry Eye Disease or, where indicated, related ocular surface diseases.

For drugs that are awaiting FDA review or are in the development process, please see Drug Pipeline.

  • DRUG: Lotilaner 0.25%

    COMPANY: Tarsus Pharmaceuticals

    INDICATION: Demodex blepharitis

    Click for complete drug label

  • DRUG: Cyclosporine ophthalmic solution 0.1%

    COMPANY: Harrow

    INDICATION: For treatment of the signs and symptoms of dry eye disease.

    Click for complete drug label

    (Note: Previously known as CyclASol.)

  • DRUG: Perfluorohexyloctane ophthalmic solution

    COMPANY: Bausch & Lomb / Novaliq

    INDICATION: For treatment of the signs and symptoms of dry eye disease.

    Click for complete drug label

  • DRUG: Varenicline solution - nasal spray 0.03mg

    COMPANY: Oyster Point Pharma (now owned by Viatris)

    INDICATION: For treatment of the signs and symptoms of dry eye disease.

    Click for complete drug label

  • DRUG: Loteprednol etabonate ophthalmic suspension 0.25%

    COMPANY: Alcon (originally Kala Pharmaceutical)

    INDICATION: For short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.

    Click for complete drug label

  • DRUG: Cyclosporine ophthalmic solution 0.09%

    COMPANY: Sun Pharmaceuticals.

    INDICATION: To increase tear production in patients with keratoconjunctivitis sicca (dry eye).

    Click for complete drug label

  • DRUG: Cenegermin, a/k/a recombinant human nerve growth factor

    COMPANY: Dompé.

    INDICATION: Orphan drug designation for neurotrophic keratitis.

    Click for complete drug label

  • DRUG: Lifitegrast 5%

    COMPANY: Bausch & Lomb (originally Shire, then Novartis)

    INDICATION: For treatment of signs and symptoms of dry eye disease.

    Click for complete drug label

  • DRUG: Cyclosporine ophthalmioc emulsion 0.05%

    COMPANY: Allergan (an Abbvie company)

    INDICATION: To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with KCS.

    Click for complete drug label

FDA-Approved Drugs

Below is a list of FDA-approved drugs for dry eye disease and certain related ocular surface disease indications.

For drugs that are awaiting FDA review or are in the development process, please see Pipeline.