Review of Selective Pharmacologic Therapies for Dry Eye Disease Treatment

Keratoconjunctivitis sicca, also known as dry eye disease (DED), is a prevalent, multifactorial disease associated with compromised ocular lubrication, ocular surface inflammation and damage, and ocular symptoms. Several anti-inflammatory, topical ophthalmic therapies are available to treat clinical signs and symptoms of DED in the USA and Europe.

Cyclosporine?A (CsA)-based formulations include an ophthalmic emulsion of 0.05% CsA (CsA 0.05%), a cationic emulsion (CE) of CsA 0.1% (CsA CE), and an aqueous nanomicellar formulation of 0.09% CsA (OTX-101). Lifitegrast is a 5% ophthalmic solution of a lymphocyte function-associated antigen?1 antagonist that is believed to target T?cell activation and recruitment to inhibit ocular inflammation.

Here we provide a comprehensive review summarising preclinical studies and pivotal trial data for these treatments to provide a complete understanding of their efficacy and safety profile. Overall, data in the evaluated studies show a favourable risk–benefit profile for the use of targeted topical anti-inflammatory pharmacologic treatments in patients with DED.

Key Summary Points:

1. Several topical pharmacologic therapies are approved for the treatment of dry eye disease; however, there are no head-to-head pivotal trials comparing these treatments.
2. A comprehensive review summarising data from preclinical studies and pivotal trials for cyclosporine ophthalmic emulsion 0.05%, cyclosporine emulsion 0.1%, cyclosporine ophthalmic solution 0.09%, and lifitegrast ophthalmic solution 5% was conducted to provide a complete understanding of their efficacy and safety profile.
3. Overall, these topical ophthalmic therapies are safe and well tolerated and demonstrate clinically and statistically significant improvements in signs and symptoms of dry eye disease.
4. Clinical data show a favourable risk–benefit profile for the use of targeted topical anti-inflammatory pharmacologic treatments in patients with dry eye disease; although many patients treated with these agents experience ocular treatment-emergent adverse events, the rate of treatment discontinuation is relatively low.
5. The specific signs and symptoms of dry eye disease that improve vary with the treatment prescribed.