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Patent for treating ocular autoimmune disorder comorbidities with roflumilast

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Published September 19th, 2025
Detected March 27th, 2026
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Summary

The USPTO has published a new patent application (US20260083712A1) assigned to Iolyx Therapeutics, Inc. The patent describes methods for treating ocular comorbidities of autoimmune disorders, such as dry eye disease, using ophthalmic formulations of roflumilast. The application was filed on September 19, 2025.

What changed

The United States Patent and Trademark Office (USPTO) has published a new patent application, US20260083712A1, filed by Iolyx Therapeutics, Inc. The patent application details methods for administering ophthalmic pharmaceutical formulations of roflumilast, a phosphodiesterase-4 inhibitor, to treat ocular comorbidities associated with autoimmune disorders, specifically mentioning dry eye disease. The described methods aim to reduce specific staining scores in patients previously diagnosed with an autoimmune disorder.

This publication represents a new patent filing and does not impose immediate compliance obligations on regulated entities. However, it signals potential future developments in the treatment of autoimmune disorder comorbidities and may be of interest to pharmaceutical companies, healthcare providers, and researchers in the ophthalmology and autoimmune disease fields. Compliance officers in the pharmaceutical sector should note this as a development in drug innovation and intellectual property within their industry.

Source document (simplified)

← USPTO Patent Applications

METHODS FOR TREATING PATIENTS WITH OCULAR COMORBIDITIES OF AN AUTOIMMUNE DISORDER

Application US20260083712A1 Kind: A1 Mar 26, 2026

Assignee

Iolyx Therapeutics, Inc.

Inventors

Erin NEWMAN, Elizabeth W. JEFFORDS, Houman David HEMMATI, Heather BERGER, Shannon DAHL

Abstract

Methods of administering ophthalmic pharmaceutical formulations of the phosphodiesterase-4 inhibitor, roflumilast, for treating patients with ocular comorbidities of autoimmune disorder, including dry eye disease. The methods include selecting a patient previously diagnosed with an autoimmune disorder and administering an ophthalmic pharmaceutical composition comprising roflumilast to the patient to treat the ocular comorbidity of the autoimmune disorder. The method can result in a reduction of a total lissamine green conjunctival staining score or a reduction in total corneal fluorescein staining score relative to baseline.

CPC Classifications

A61K 31/44 A61K 9/0048 A61P 27/02

Filing Date

2025-09-19

Application No.

19334559

View original document →

Classification

Agency
USPTO
Published
September 19th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
US20260083712A1

Who this affects

Applies to
Patients Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Development Ophthalmology Treatments
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Legal
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Healthcare Drug Development

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