2023年11月2日 · Cyclosporine ophthalmic solution 0.09% (CEQUA®; OTX-101), which was developed as a novel nanomicellar solution in contrast to the oil-in-water emulsion of CsA, was approved by the FDA in 2018 to increase tear production in patients with DED [9, 11].

Background: OTX-101 (CEQUA™) is approved in the United States for treatment of keratoconjunctivitis sicca (KCS). This pooled analysis of 2 studies (phase 2b/3 and phase 3) evaluates the efficacy and safety of OTX-101 0.09% in the intent-to-treat (ITT) population and the subgroup of patients with a baseline Schirmer score less than 10 mm.

Purpose: To evaluate the safety and efficacy of OTX-101, a novel aqueous nanomicellar formulation of cyclosporine (0.09%), in the treatment of patients with dry eye disease (DED). Design: A randomized, multicenter, vehicle-controlled, double-masked, phase 3 clinical trial.

2019年7月10日 · OTX-101 (CsA 0.09%, CEQUA; Sun Pharmaceutical Industries, Inc, Cranbury, NJ) is approved by the Food and Drug Administration to increase tear production in patients with KCS. 11 OTX-101 is a novel nanomicellar solution of CsA that improves the bioavailability of the active ingredient in ocular tissues, with negligible systemic exposure (see ...

2023年11月2日 · Cyclosporine ophthalmic solution 0.09% (CEQUA®; OTX-101), which was developed as a novel nanomicellar solution in contrast to the oil-in-water emulsion of CsA, was approved by the FDA in 2018 to increase tear production in patients with DED [ 9, 11 ].

环孢素眼用溶液 0.09%（CEQUA®；OTX-101）、环孢素眼用乳剂 0.05%（Restasis®；CsA）和 lifitegrast 滴眼液 5%（Xiidra®；LFT）是适用于 DED 的抗炎药。 该分析比较了接受 OTX-101、CsA 或 LFT 治疗的 DED 患者的治疗模式。

The aim of this study was to evaluate the safety and efficacy of OTX-101, a clear nanomicellar aqueous solution of cyclosporine, in the treatment of dry eye disease (DED). This was a 12-week multicenter, randomized, prospective, double-masked, ...

OTX-101 0.09% is a clear aqueous nanomicellar formulation of cyclosporine that may prove to be a useful addition to the armamentarium of agents for the treatment of DED. The technology used in the OTX-101 0.09% formulation allows for a stable solution with more than a 10-fold increase in the aqueous solubility of cyclosporine.

2014年9月29日 · 本研究是 otx-101 的第一项临床安全性和有效性研究，旨在比较两种剂量浓度的 otx-101 与载体（安慰剂）在减少 kcs 体征和症状方面的作用，并评估双眼每天给药两次时的安全性在 84 天的时间内。

OTX-101 (CEQUA™), a novel nanomicellar cyclosporine formulation, has been approved in the US for the treatment of KCS. We present a pooled analysis of efficacy and safety from a phase 2b/3 and a phase 3 randomized, multicenter, double-masked, vehicle-controlled study evaluating OTX-101 in patients with KCS.