Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-02-10
2004-05-04
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S912000
Reexamination Certificate
active
06730691
ABSTRACT:
INTRODUCTION
The present invention relates to methods and compositions for inhibiting undesirable visual anomalies commonly experienced by individuals who have undergone refractive eye surgery. Specifically, the methods and compositions of the invention provide a means for inhibiting photophobia, glare, secondary images and haloing. The methods of the invention comprise the post-operative administration of an ophthalmic solution comprising alpha adrenergic blocking agents to the surface of the eye. The invention is based on the observation that when alpha adrenergic blocking agents are applied to the surface of the eye, the composition is well tolerated and the pupil is made smaller by relaxing the iris without induced myopia. The invention further provides for the use of an ophthalmic solution comprising alpha adrenergic blocking agents to eliminate symptoms developed by conditions wherein the diameter of the pupil exceeds the diameter desired for the respective optic zone. The present invention, by enabling a method for the use of an ophthalmic solution comprising alpha adrenergic blocking agents, provides a safer and less severe treatment than those methods that utilize the administration of pilocarpine or other compositions that forcibly make the pupil smaller.
BACKGROUND OF THE INVENTION
The long-term success of refractive eye surgery is currently limited by the high incidence of undesirable visual anomalies, such as photophobia, glare, secondary images and haloing, experienced by individuals who have undergone refractive eye surgery. Refractive procedures include and are not limited to the surgical implantation of an intraocular lens, laser surgery, and radial keratotomy. Post-operative complications exist because the refractive procedure causes a differential between the corrected optic zone and the diameter of the pupil. Such a differential generally leads to persistent incidence of undesirable visual anomalies, particularly in certain situations, including but not limited to mesopic conditions of reduced illumination and, conversely, conditions of bright light experienced while driving a motor vehicle at night.
A method of treating individuals who experience undesirable visual anomalies after refractive eye surgery does not exist without causing induced myopia and headaches caused by contraction of the ciliary body associated with the application of pilocarpine or other compositions that forcibly make the pupil smaller. These agents may create risk of retinal detachment as well as photopsia. It is known that pilocarpine has been used after an ophthalmologist has induced dilation of the pupil in order to forcibly hasten the return of the iris at the conclusion of an examination or procedure to a constricted state. It is also known that dapiprazole, manufactured by Storz Instruments Co. (which was acquired by Bausch & Lomb) under the tradename Rev Eyes, is used to hasten the return of the pupil to normal size after dilation by an examiner. To Applicant's knowledge, the product Rev Eyes is instilled in the patient by the physician or optometrist in the doctor's office. Further, this product is limited by its short shelf life. Unfortunately, though the cyclotonic agents hasten the return of the iris to a normal position, they create induced myopia and cause headaches in patients. Most patients suffer from the side-effects associated with the usage of these conventional drugs.
It is known that alpha adrenergic blocking agents have been used for the treatment of angle closure glaucoma, which condition causes an increased pressure within the eyeball causing a gradual loss of sight. It is also known that alpha adrenergic blocking agents, such as thymoxamine, have been used to reverse mydriasis induced by sympathomimetic agents during the implantation of an intraocular lens in order to increase the success of fixating the lens inside the eye. Other anti-mydriatic uses of thymoxamine are discussed in Wand & Grant, Arch. Ophthalmol. 96:1009-1011 (July 1978) and Wand & Grant, Surv. Ophthalmol. 25(2):75-84 (Sept.-Oct. 1980). To Applicant's knowledge, it has not been known that alpha adrenergic blocking agents may be used to eliminate undesirable visual anomalies experienced by patients who have undergone refractive eye surgery.
There has been a long felt need since the inception of refractive procedures to eliminate undesirable visual anomalies experienced by patients who have undergone refractive eye surgery.
SUMMARY OF THE INVENTION
The present invention provides compositions and methods for using an ophthalmic solution comprising alpha adrenergic blocking agents that inhibit undesirable visual sequelae commonly experienced by individuals who have undergone refractive eye surgery. The invention further provides for the use of an ophthalmic solution comprising alpha adrenergic blocking agents to eliminate symptoms developed by conditions wherein the diameter of the pupil exceeds the diameter desired for the respective optic zone. Specifically, the compositions and methods of the invention provide a means for inhibiting photophobia, glare, secondary images and haloing.
Accordingly, the methods of the present invention comprise topically applying an ophthalmic solution to the eye wherein the ophthalmic solution contains a therapeutically effective amount of one or more alpha adrenergic blocking agents to an individual who has undergone refractive eye surgery. Moreover, the composition may be topically applied in approximately a one drop dose, which may be instilled on an as needed basis depending upon the concentration and rate of release of the one or more alpha adrenergic blocking agents within the ophthalmic solution.
In yet another embodiment of the invention, the methods comprise topically applying an ophthalmic solution to the eye wherein the ophthalmic solution contains a therapeutically effective amount of one or more alpha adrenergic blocking agents to an individual who has one or more symptoms developed by a condition wherein the diameter of the pupil exceeds the diameter desired for the respective optic zone of the eye. Such conditions include but are not limited to post surgical persistent mydriasis, traumatic mydriasis, anisocoria, photorefractive keratectomy, treatment of aphakia, and certain cases of cataract extraction and retinal detachment.
The invention further provides for compositions comprising one or more alpha adrenergic blocking agents in a physiologically acceptable carrier, which can be administered to a subject at an effective dose to be therapeutically effective in concentration and rate of release. The compositions used in the practice of the present invention comprise both rapid and sustained release of an effective dose.
In another embodiment, the alpha adrenergic blocking agents may be used preoperatively in cases where small pupils are demanded. This is particularly valuable in refractive implantation, glaucoma surgery, and keratoplasty to mention a few.
In an alternative non-limiting embodiment, the invention further provides for compositions comprising a therapeutically effective amount of one or more alpha adrenergic blocking agents in combination with one or more anti-irritant agents and/or one or more anti-inflammatory agents.
The invention is based on the observation that administration of one or more alpha adrenergic blocking agents to the surface of the eye is well tolerated and is effective in eliminating one or more undesirable visual problems without experiencing a change in focal length, headache, photopsia, floaters, etc, which are ordinarily experienced with induced cyclotonic miosis. The present invention, by enabling a method for use of an ophthalmic solution comprising one or more alpha adrenergic blocking agents, provides a safer, less risky, and asymptomatic treatment than experienced with the administration of pilocarpine or other compositions that forcibly make the pupil smaller.
REFERENCES:
patent: 3658963 (1972-04-01), Turner et al.
patent: 3966779 (1976-06-01), Satzinger et al.
patent: 4252721 (1981-02-01),
Baker & Botts LLP
Fay Zohreh
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