Acquired Blepharoptosis is a condition in which the upper eyelids droop. Though this condition is occasionally seen in association with serious diseases, the majority of patients develop the condition as part of the natural aging process. Some patients with this condition may complain of reduced vision. For those experiencing reduced vision, it may be narrowing of their visual fields or field-of-view especially when looking up. Other patients may complain of an appearance of an elderly eye or face or being fatigued or sleep deprived. Some patients seek treatment for their visual field defects and others seek treatment simply for cosmetic purposes. The surgical approach called blepharoplasty, involves cutting into the upper lid to tighten the muscle or to eliminate excess skin. More than 100,000 patients per year undergo this surgery each year in the United States.
LEV-102 is a proprietary odorless, colorless, rapidly drying aqueous gel. It is intended to be applied in small volume to the upper lids, similar to eyeshadow. For patients who also use eyeshadow for cosmetic purposes, LEV-102 is designed to function as an eyeshadow primer.
The active pharmaceutical ingredient in LEV-102 is a drug called oxymetazoline. The gel also has stabilizers and permeation enhancers. Oxymetazoline has been approved for various uses in the U.S. for more than forty years. LEV-102 is designed so that the oxymetazoline can penetrate the upper lid and reach the tiny involuntary ‘fight or flight’ muscle in the lid called Mueller’s muscle. The drug then binds to the muscle and triggers a slight contraction that is designed to lift the upper lid in a similar manner to what one might see if a person is suddenly startled. The concept is to raise the upper lid and improve the individual’s upper visual fields as well the appearance of the eye. LEV-102 is not designed to affect an individual’s voluntary eye muscles that control the opening and closing of the eye, therefore no effects on these voluntary muscles is anticipated. LEV-102 is designed to be a once a day topically applied medication.
LEV-102 is not currently approved for sale or use outside of a clinical trial in the U.S. or any other country. Levation Pharma is currently sponsoring a Phase I/II clinical trial at several centers in the U.S. The trial is designed to develop preliminary information related to the safety, tolerability and possible effectiveness of LEV-102. For further information on the clinical trial and the sponsor please refer to: www.clinicaltrials.gov # NCT05715346
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