Granted Patent
B2
US 12,186,234 · App. 16/444,894 · Granted Jan 7, 2025
Topical ocular delivery methods and devices for use in the same
Inventors:
Yehuda Ivri (Newport Coast, CA); Mark S. Blumenkranz (Portola Valley, CA); Peter Noymer (Los Gatos, CA); Daniel V. Palanker (Sunnyvale, CA)
Assignee:
Bausch + Lomb Ireland Limited
A61F9/0008A61K9/0048A61K31/135A61K31/216A61K31/4178A61K31/4409A61K31/46A61K31/472A61K45/06A61P27/06A61P27/10A61K31/573A61K47/34
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Abstract
Methods of administering a liquid formulation of an ophthalmic agent to a topical ocular location of an eye are provided. Aspects of the methods include delivering to the topical ocular location a dose of the liquid formulation that can be wholly accommodated by the tear film of the eye. Devices and kits for practicing the methods are also provided. The methods, compositions and kits find use in a variety of applications, including therapeutic, diagnostic and cosmetic applications.
Claims (19)
1. A method of treating a subject for an ophthalmic condition, the method comprising:
providing a handheld device having a volume of liquid, an aperture through which the liquid can be ejected as a stream towards a target eye of the subject, and a concave mirror disposed downstream of the aperture and having an opening through which fluid from the aperture can be directed;
moving the handheld device until the subject can observe an image of the target eye in the concave mirror becoming focused, indicating alignment of the handheld device with the target eye; and
activating an actuator engaging the handheld device to generate pressure fluctuations within the liquid inside the handheld device and to disengage a rod disposed within the handheld device from the aperture to unseal the aperture and administer the liquid, through the aperture, to the aligned target eye.
2. The method according to claim 1 , wherein the activating step includes administering 3 to 10 μl of the liquid through the aperture.
3. The method according to claim 1 , wherein the liquid does not include any agent that ameliorates an adverse effect of a therapeutic agent.
4. The method according to claim 3 , wherein the therapeutic agent is a sole active agent in the liquid.
5. The method according to claim 1 , wherein a concentration of a therapeutic agent within the liquid ranges from 50 ng/ml to 100 mg/ml.
6. The method according to claim 1 , wherein a volume of a therapeutic agent delivered to the target eye is determined from pulse duration of the actuator and active agent concentration in the liquid.
7. The method according to claim 1 , wherein the handheld device comprises a volume of the liquid sufficient to provide multiple applications.
8. The method according to claim 1 , wherein the liquid is preservative-free.
9. The method of claim 1 , wherein the ophthalmic condition is selected from the group consisting of: presbyopia, glaucoma, myopia, and dry eye.
10. The method of claim 1 , wherein a radius of curvature of the concave mirror is in a range from 60 mm to 120 mm.
11. The method of claim 1 , wherein a diameter of the concave mirror is in a range from 15 mm to 30 mm.
12. The method of claim 1 , wherein a distance between the aperture and the target eye is in a range from 30 mm to 60 mm when the subject has properly aligned the handheld device using the mirror.
13. A method of delivering a liquid, the method comprising: providing a liquid delivery device having a reservoir containing the liquid, an aperture through which the liquid is ejected from the liquid delivery device, and a biasing mechanism to engage and create a seal with the aperture to prevent ingress of bacteria and contaminants through the aperture, and into the liquid delivery device, when liquid is not being ejected therethrough; and a concave mirror disposed downstream of the aperture and having an opening through which fluid from the aperture can be directed; and oscillating an actuator to 1) generate pressure fluctuations inside the reservoir and 2) disengage the biasing mechanism from the aperture; and ejecting the liquid as a stream through the aperture towards a site of interest as a result of the pressure fluctuations inside the liquid delivery device, such that a volume of liquid delivered to the site of interest is substantially known.
14. The method according to claim 13 , wherein, in the step of providing, the liquid includes an ophthalmic agent having a concentration ranging from about 50 ng/ml to about 100 mg/ml.
15. The method according to claim 13 wherein, in the step of providing, the biasing mechanism is designed to engage, at a first end, the aperture to selectively seal the aperture and to be affixed, at a second end, to a flexible membrane to facilitate movement of the biasing mechanism relative to the aperture.
16. The method according to claim 13 , wherein, in the step of providing, the biasing mechanism is moveable relative to the aperture between a first position that seals the aperture and a second position that permits liquid to be ejected through the aperture.
Assignments (9)
ASSIGNMENT OF SECURITY INTEREST IN PATENTS PREVIOUSLY RECORDED AT REEL/FRAME (066694/0131)
Recorded Aug 14, 2025
From: CITIBANK, N.A., AS RESIGNING AGENT
To: JPMORGAN CHASE BANK, N.A., AS SUCCESSOR AGENT
Reel/Frame 072460/0655 →
PATENT SECURITY AGREEMENT
Recorded Jul 1, 2025
From: BAUSCH & LOMB INCORPORATED; ALDEN OPTICAL LABORATORIES, INC.; BAUSCH + LOMB IRELAND LIMITED
To: CITIBANK, N.A., AS NOTES COLLATERAL AGENT
Reel/Frame 071773/0871 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT
Recorded Feb 29, 2024
From: BAUSCH + LOMB IRELAND LIMITED
To: CITIBANK, N.A., AS NOTES COLLATERAL AGENT
Reel/Frame 066707/0684 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT
Recorded Feb 27, 2024
From: BAUSCH + LOMB IRELAND LIMITED
To: CITIBANK, N.A., AS COLLATERAL AGENT
Reel/Frame 066694/0131 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 9, 2023
From: NOVARTIS AG
To: BAUSCH + LOMB IRELAND LIMITED
Reel/Frame 065531/0583 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNMENT AGREEMENT PREVIOUSLY RECORDED ON REEL 062116 FRAME 0917. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT.
Recorded Jul 10, 2023
From: KEDALION THERAPEUTICS, INC.
To: NOVARTIS AG
Reel/Frame 064237/0507 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Dec 13, 2022
From: KEDALION THERAPEUTICS, INC.
To: NOVARTIS AG
Reel/Frame 062116/0917 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jun 5, 2020
From: PALANKER, DANIEL V.
To: KEDALION THERAPEUTICS, INC.
Reel/Frame 052856/0223 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jun 19, 2019
From: IVRI, EHUD; BLUMENKRANZ, MARK; NOYMER, PETER
To: KEDALION THERAPEUTICS, INC.
Reel/Frame 049517/0660 →
Continuity (4)
Continuation In Part
PCTUS2019027018
· Apr 11, 2019
Provisional Application
62814764
· Mar 6, 2019
Provisional Application
62656552
· Apr 12, 2018
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