Drug intelligence / Profile preview

OTX-101

Development stage
Approved
Lead developer
Sun Pharmaceutical Industries
Modality
Small Molecules, Nanoparticles → Drug Delivery Systems
Administration
Ophthalmic
01

Overview

OTX-101 is a novel, patented nanomicellar aqueous ophthalmic solution of cyclosporine A (0.09%) developed for the treatment of dry eye disease (DED), also known as keratoconjunctivitis sicca (KCS). The nanomicellar technology encapsulates the lipophilic cyclosporine molecules within micelles, enhancing their solubility and bioavailability in ocular tissues while minimizing systemic exposure[1][4][5]. This formulation allows for improved delivery and tolerability compared to traditional emulsions. OTX-101 acts as an immunomodulator by inhibiting T-cell activation and reducing ocular surface inflammation associated with DED[1]. It is approved in the United States under the brand name CEQUA to increase tear production in patients with DED/KCS[2][5]. Clinical trials have demonstrated that OTX-101 significantly improves tear production and ocular surface integrity versus vehicle, with most adverse events being mild to moderate in severity[2][6].

Brand names
CEQUA
Other names
cyclosporine nanomicellar ophthalmic solution 0.09%
02

Targets

CN (Calcineurin)

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