Ophthalmic compositions for treatment of ocular surface damage and symptoms of dryness

An ophthalmic composition, the technology of the composition, applied in the directions of drug combination, drug delivery, halogenated hydrocarbon active ingredients, etc., can solve problems such as inactivity

Pending Publication Date: 2021-04-30
NOVALIQ GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in this role, semifluorinated alkanes have only been taught as pharmaceutically inactive solvents for active therapeutic agents

Method used

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  • Ophthalmic compositions for treatment of ocular surface damage and symptoms of dryness
  • Ophthalmic compositions for treatment of ocular surface damage and symptoms of dryness
  • Ophthalmic compositions for treatment of ocular surface damage and symptoms of dryness

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0413] Example 1: American clinical research

[0414] A phase 2, multicenter, randomized, double-blind, saline-controlled study was conducted to evaluate the effect of 1-perfluorohexyloctane (NOV03) on the signs and symptoms of dry eye disease (DED) under two different dosing regimens . The study was conducted in 11 study cities in the United States. This study was reviewed and approved by the respective ethics committees and registered at www.clinicaltrials.gov (NCT03333057).

[0415] The main objective of this study was to evaluate the effect of an ophthalmic composition consisting essentially of 1-perfluorohexyloctane (NOV03) on two different dosing regimens (QID, BID) in patients with dry Efficacy, safety and tolerability in subjects with ocular disease. The secondary objective was to compare the effects of an ophthalmic composition consisting essentially of 1-perfluorohexyloctane (NOV03) and saline solution on the signs and symptoms of dry eye disease under two differe...

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Abstract

The present disclosure provides methods of treatment using ophthalmic compositions, comprising 1-perfluorohexyloctane, which are useful in the treatment of ocular surface damage of the cornea and / or symptoms of dryness.

Description

technical field [0001] This disclosure relates to the field of ophthalmic compositions comprising 1-perfluorohexyloctane, which are useful for treating ocular surface damage and / or dryness of the cornea. Background technique [0002] Keratoconjunctivitis sicca (also known as dry eye disease (DED) or tear dysfunction syndrome) is a dysfunction of the tear film and ocular surface that results in discomfort, visual disturbance, and often even damage to the ocular surface. Its prevalence varies widely by region and is estimated to range from about 7.4% in the United States to about 33% in Japan (J.L. Gayton, Clinical Ophthalmology 2009:3, 405-412). According to another estimate, approximately 3.2 million women and 1.05 million men have keratoconjunctivitis sicca in the United States alone. If cases with mild symptoms are also considered, there could be as many as 20 million affected people in the United States. [0003] Dry eye disease (DED) is today divided into two main cate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/02A61P27/02A61P27/04
CPCA61K31/02A61P27/02A61P27/04A61K9/0048
Inventor M·贝尔D·维伦S·克罗斯T·施吕特
Owner NOVALIQ GMBH
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