Abstract: The present invention relates to high concentration ophthalmic pharmaceutical formulations of the phosphodiesterase-4 inhibitor, roflumilast, which are suitable for intravitreal or other ocular administration to injection sites internal or external to the eye and orbit. The compositions can comprise about 2% to about 5% w/v of roflumilast, a viscosity agent, a tonicity agent, a buffer agent, a surfactant, and water. The pharmaceutical compositions are stable with little to no impurities and can be injected from a 27 Gauge or 30 Gauge syringe with minimal force, resulting in therapeutic levels of pharmaceutical in relevant tissues for the ocular surface, anterior compartment, vitreous/posterior compartments, and tissues or chambers surrounding the eye.
Type:
Application
Filed:
September 15, 2023
Publication date:
April 11, 2024
Applicant:
lolyx Therapeutics, Inc.
Inventors:
Richard GRAHAM, Elizabeth W. JEFFORDS, Hovhannes J. GUKASYAN, Shannon DAHL