Levation Pharma Initiates Phase I/II Clinical Trial of LEV102 for Acquired BlepharoptosisDouble Masked, Placebo Control Study at Three Prominent U.S. Sites
2023-02-27
临床研究临床申请
LOS ANGELES, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Levation Pharma Ltd., a pharmaceutical company focused on the development of new therapeutics for the ophthalmology and aesthetic space, received FDA clearance to initiate a Phase I/II of LEV102 for the treatment of Acquired Blepharoptosis in adults. Acquired Blepharoptosis, or drooping of the upper eye lid, is a common condition associated with both age or underlying medical conditions. Patients may complain of impaired visual field as well aesthetically unpleasing eyes giving the appearance of aging and tiredness.
LEV102 is a proprietary aqueous gel comprised of a variety of penetration enhancers and oxymetazoline as the active pharmaceutical ingredient. Oxymetazoline is an alpha-adrenergic agonistalpha-adrenergic agonist that is intended to activate the receptors on Mueller’s muscle in the upper lid. Mueller’s is the involuntary ‘fight or flight’ muscle that raises the lid; for example, when one is startled. The medication is applied in small quantities to the upper lid. The penetration enhancers permit transdermal permeation of the drug though the lid to reach the alpha receptors on Mueller’s muscle, inducing upper lid elevation. LEV102 is a colorless, odorless, rapidly drying gel. The product is designed to function as a primer and be compatible with commercially available eye shadows. The clinical trial is designed to determine preliminary safety and efficacy signals for LEV102 as a potential treatment for Acquired Blepharoptosis in adults.
“We are delighted to initiate our clinical trial which follows several years of iterative development and testing to achieve a formulation that is designed to be both clinically beneficial and aesthetically pleasing,” said Houman Hemmati M.D., Ph.D., Chief Medical Officer of Levation Pharma. “LEV102 was carefully designed to meet a potentially large market and an unmet clinical need in the area of ophthalmology. Specifically, a simple-to-apply topical eyelid agent capable of raising the upper lid in patients with symptoms and signs of blepharoptosis.”
Dr. Steve Yoelin of Newport Beach, California commented, “The use of medication to raise the upper lid in cases of acquired blepharoptosis is of increasing interest to medical providers and patients alike. I am always interested in novel drug delivery systems. I am looking forward to learning how LEV102 performs in this clinical trial.”
About Levation Pharma
Levation Pharma is an Israeli-American company operating out of Los Angeles. It is venture backed by prominent venture firms Pontifax and Peregrine amongst other investors. For further information see our website at .
LEV102 in an Investigational New Drug and is not approved for any indications. For further information see (#NCT05715346).
For more information, please contact:
Levation Pharma, Ltd.
info@levationpharma.com
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