Levation Pharma has initiated a Phase I/II trial to evaluate the preliminary safety and potential efficacy of their investigational topical gel LEV102 for acquired blepharoptosis in adults. Acquired blepharoptosis is a common upper eyelid disorder that is primarily treated with surgery. This is the first clinical trial that the company has launched for LEV102.
What Is Acquired Blepharoptosis?
Also known as “ptosis,” blepharoptosis is a neuromuscular condition that causes drooping of one or both eyelids that affects 4.7 to 13.5 percent of adults. Acquired blepharoptosis develops later in life, while congenital blepharoptosis is present at birth. This condition can obstruct the visual field and therefore cause vision problems; however, patients also experience appearance-related distress, which can lead to anxiety and depression.
Blepharoptosis results from dysfunction of an involuntary, smooth muscle called the superior tarsal, or Müller’s muscle, which helps elevate the eyelid along with the levator palpebrae superioris muscle. Müller’s muscle predominantly expresses alpha-adrenergic receptors, which help support muscle function in the eye.
Surgical treatment for blepharoptosis, which is standard of care, involves targeting Müller’s muscle to lift the eyelid to improve aesthetic appearance and improve the visual field. Non-surgical treatment options are currently limited.
How Does LEV102 Work?
LEV102 is an aqueous topical gel that contains a drug called oxymetazoline, which is used in medications to treat nasal congestion and sinus pressure. Oxymetazoline is an alpha-adrenergic agonist that may treat acquired blepharoptosis by increasing activity of Müller’s muscle within the eyelid. LEV102 is designed to facilitate oxymetazoline penetration of the upper lid to reach Müller’s muscle where it binds and contracts to lift the upper eyelid.
Studies have indicated that oxymetazoline 0.1 percent solution is safe and effective in helping sustain upper eyelid elevation and improve visual problems. Therefore, LEV102, which has a similar mechanism of action with a different delivery system, could provide an alternative to surgery.
What Will This Clinical Trial Evaluate?
Levation Pharma is conducting a Phase I/IIa, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group trial to evaluate the effects of LEV102 in adult subjects with acquired blepharoptosis. Approximately 30 participants will receive two different doses of the ophthalmic gel externally on the upper eyelid of both eyes in a one-time application of LEV102 1.0% (Phase 1 trial), LEV102 1.0% (Phase II trial), or vehicle. The primary outcome of both studies is safety and tolerability (Days 2-5) and upper eyelid height (Day 1).
To participate in the study, patients must be 25 years or older and have aesthetic or visual problems due to acquired blepharoptosis. In addition, one eye must have a Margin Reflex Distance 1 (MRD1) ≤2 mm, and the patient must have current corrected visual acuity; they also must demonstrate an upper eyelid elevation ≥0.5 mm change from baseline in MRD1 in both eyes in response to a single drop treatment to each eye at screening. Exclusion criteria include comorbid ocular conditions, including infections, and certain concomitant medications; patients must not be pregnant or breastfeeding.
“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 Dr. Houman Hemmati, Chief Medical Officer of Levation Pharma, in a press release.
This study is not yet recruiting but clinical trial pages are updated often.