IP Library › Granted Patent US 12,735,389
Granted Patent B2
US 12,735,389 · App. 18/619,535 · Granted Sep 15, 2026

Highly pure phentolamine mesylate and methods for making same

Inventor: Daniela Carmen Oniciu (Gainesville, FL)
Assignee: Opus Genetics, Inc.
C07D233/24
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Quick Facts
Patent No.
US 12,735,389
App. No.
18/619,535
Granted
Sep 15, 2026
Kind
B2
Abstract

This invention provides methods for synthesizing phentolamine mesylate from phentolamine and methanesulfonic acid in the presence of acetone and water. The methods of the present invention provide highly pure phentolamine mesylate. The invention also provides highly pure phentolamine mesylate.

Claims (21)

1 . An ophthalmic solution comprising phentolamine mesylate that exhibits an X-ray powder diffraction (XRPD) pattern comprising a peak at 6.87±0.2 degrees 2-theta, a peak at 11.65±0.2 degrees 2-theta, a peak at 13.15±0.2 degrees 2-theta, a peak at 18.86±0.2 degrees 2-theta, a peak at 20.32±0.2 degrees 2-theta, a peak at 20.85±0.2 degrees 2-theta, a peak at 21.07±0.2 degrees 2-theta, and a peak at 21.36±0.2 degrees 2-theta.

2 . The ophthalmic solution of claim 1 , wherein the ophthalmic solution comprises the phentolamine mesylate in an amount of about 0.5% to about 2% by weight of the ophthalmic solution, wherein about is up to plus or minus 10%.

3 . The ophthalmic solution of claim 1 , wherein the ophthalmic solution comprises the phentolamine mesylate in an amount of about 1% by weight or volume of the ophthalmic solution, wherein about is up to plus or minus 10%.

4 . A method for treating a dim or night vision disturbance, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 1 .

5 . A method for treating a dim or night vision disturbance, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 2 .

6 . A method for treating a dim or night vision disturbance, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 3 .

7 . A method for treating or reversing pharmacologically induced mydriasis, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 1 .

8 . A method for treating or reversing pharmacologically induced mydriasis, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 2 .

9 . A method for treating or reversing pharmacologically induced mydriasis, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 3 .

10 . A method for treating presbyopia, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 1 .

11 . A method for treating presbyopia, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 2 .

12 . A method for treating presbyopia, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 3 .

13 . A method for improving visual contrast sensitivity or visual acuity, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 1 .

14 . A method for improving visual contrast sensitivity or visual acuity, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 2 .

15 . A method for improving visual contrast sensitivity or visual acuity, comprising administering to a subject in need thereof an effective amount of the ophthalmic solution of claim 3 .

16 . A method for inhibiting contraction of smooth muscle of a subject's iris, comprising administering to the subject in need thereof an effective amount of the ophthalmic solution of claim 1 .

17 . A method for inhibiting contraction of smooth muscle of a subject's iris, comprising administering to the subject in need thereof an effective amount of the ophthalmic solution of claim 2 .

18 . A method for inhibiting contraction of smooth muscle of a subject's iris, comprising administering to the subject in need thereof an effective amount of the ophthalmic solution of claim 3 .

19 . A method for reducing a subject's pupil diameter, comprising administering to the subject in need thereof an effective amount of the ophthalmic solution of claim 1 .

20 . A method for reducing a subject's pupil diameter, comprising administering to the subject in need thereof an effective amount of the ophthalmic solution of claim 2 .

21 . A method for reducing a subject's pupil diameter, comprising administering to the subject in need thereof an effective amount of the ophthalmic solution of claim 3 .

Assignments (3)
SECURITY INTEREST Recorded Apr 21, 2026
From: OPUS GENETICS, INC.
To: OPCM SA LLC, AS PURCHASER AGENT FOR THE SECURED PARTIES
Reel/Frame 075478/0138 →
CHANGE OF NAME Recorded Dec 27, 2024
From: OCUPHIRE PHARMA, INC.
To: OPUS GENETICS, INC.
Reel/Frame 069793/0367 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 28, 2024
From: ONICIU, DANIELA CARMEN
To: OCUPHIRE PHARMA, INC.
Reel/Frame 066937/0858 →
Priority Claims (1)
CN 202110679032.9 · Jun 18, 2021 · national
Continuity (4)
Continuation 18091761 · Dec 30, 2022
Continuation 17747656 · May 18, 2022
Provisional Application 63189839 · May 18, 2021
Related Publication 20240308967A1 · Sep 19, 2024
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