Implantable scaffolds for treatment of sinusitis
AssigneeLyra Therapeutics, Inc.
InventorsChangcheng You, Quynh Pham, Danny Concagh
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Abstract
This disclosure describes, inter alia, materials, devices, kits and methods that may be used to treat chronic sinusitis. An implant is configured to fit inside of the middle meatus of a human nasal cavity. The implant includes a therapeutic-agent formulation containing a layer of over 2000 micrograms of mometasone furoate. The implant releases the mometasone furoate for more than 12 weeks. A second implant can also be provided configured to fit inside the middle meatus. The second implant also includes a therapeutic-agent formulation containing a layer of over 2000 micrograms of mometasone furoate, and releases the mometasone furoate for more than 12 weeks.
Claims67
1-70. (canceled)
An implant configured to fit inside the middle meatus, said implant comprising a coating comprising over 2000 micrograms of mometasone furoate, said implant configured to release said mometasone furoate for more than 12 weeks.
A combination therapy for use in a method of treating a sinus condition,
- providing first and second implants, each comprising at least one coating containing over 2000 micrograms of mometasone furoate,
- wherein the first implant is configured to fit inside a first middle meatus of a patient, the mometasone furoate configured to be released into a first nasal cavity for more than 12 weeks;
- and
- wherein the second implant is configured to fit inside a second middle meatus of said patient, the mometasone furoate configured to be released into a second nasal cavity for more than 12 weeks.
A method of evaluating implant effectiveness, comprising:
- a. determining a first Sinonasal Outcomes Test (SNOT-22) severity score of a patient experiencing at least two symptoms consisting of nasal obstruction, nasal congestion, difficulty breathing through nasal passages, nasal polyp, nasal discharge, and facial pain;
- b. placing a first tubular implant into a middle meatus of a said patient, said implant comprising mometasone furoate;
- and
- c. determining a second SNOT-22 severity score of said patient after implantation, wherein said second SNOT-22 severity score is lower than a first SNOT-22 severity score.
The method of claim 38, wherein said substantially linear release is exhibited in vitro in pH 7.4 PBS buffer containing 2% SDS at 37° C.
An implant that fits inside the middle meatus, said implant comprising a coating comprising over 2000 micrograms of mometasone furoate, said implant configured to reduce the Sinonasal Outcomes Test (SNOT-22) severity score of a patient by at least 9 units after implantation.
The use of a tubular implant comprising mometasone furoate to treat a sinus condition, said sinus condition characterized by at least two symptoms selected from the group consisting of nasal obstruction, nasal congestion, difficulty breathing through nasal passages, nasal polyp, nasal discharge, and facial pain.
Dependencies are inferred from the claim text.