Seciera cyclosporine formulation improves tear production in phase 2b/3 trial
Seciera significantly improved tear production and reduced ocular surface inflammation in a phase 2b/3 clinical trial, Auven Therapeutics announced in a press release.
Seciera (OTX-101) is a nanomicellar formulation of cyclosporine that uses patent-protected technology to enhance penetration into targeted ocular tissues. It is a clear, preservative-free isotonic aqueous solution.
The randomized, double-masked, placebo-controlled trial included 455 patients and was conducted at 28 sites in the U.S.
According to the release, the 0.05% and 0.09% concentrations of Seciera showed statistical superiority over placebo in meeting the primary endpoint of change in conjunctival lissamine green staining from baseline at 12 weeks.
In addition, both concentrations of the agent showed superiority to placebo in tear production and corneal fluorescein staining at 12 weeks.
The 0.09% concentration of Seciera showed superiority to placebo in a responder analysis of tear production and in central and temporal corneal staining.
The 0.09% dose appeared to be superior to the 0.05% dose in several key outcome measures.
Both doses of Seciera were well-tolerated, and more than 90% of patients completed the 12-week study, the release said.
A phase 3 study and a long-term safety study of the novel dry eye treatment are scheduled to begin in early 2016.