All Eyes On XAF5 Ointment

Topokine Therapeutics, a Boston-based biotech company, said that XAF5 Ointment met its pre-specified primary endpoint in a Phase 2 study for the reduction of excess eyelid fat, commonly known as  “eye bags” and technically known as steatoblepharon.

Topokine contends the topical treatment could be the first prescription medication to treat this condition.

XAF5 Ointment was well tolerated, according to the firm, which presented at the American Academy of Dermatology in San Francisco on Saturday. The study met its primary endpoint on intent-to-treat analysis, with nearly half of patients in the XAF5 group showing bilateral improvement of at least 1 grade on the clinician-reported Lower Eyelid Steatoblepharon Severity (LESS) scale (p = 0.02).      

“This was a carefully controlled study with multiple, independent physician- and patient-reported endpoints.  The results provide a rich, coherent picture of the physical and psychosocial treatment response,” said Dr. Michael S. Singer, who is an ophthalmologist and Topokine’s chief scientific officer.  “XAF5 not only reduced the volume of eyelid fat but also improved the patient’s overall sense of facial attractiveness.  Patients who used XAF5 felt happier about their appearance and reported looking more youthful and well-rested.”

“Eye bags are a very common concern among patients in my dermatology practice,” said Jeffrey S. Dover, MD, FRCPC, a member of the company’s Scientific Advisory Board and past president of the American Society for Dermatologic Surgery.  “If approved, XAF5 Ointment would be the first prescription medication to treat this condition.”

“Today’s face and body contouring market is defined by surgery and office-based procedures with injectables and devices,” said Murat Kalayoglu, MD, PhD, the company’s president and CEO.  “We believe that existing therapies represent only the tip of the iceberg, with a vast number of people holding out for once-daily topical therapies, such as XAF5 Ointment, for use at home.”

Topokine Therapeutics initiated the clinical trials with XAF5 (XOPH5) Ointment for reduction of fat pouches around the eyelids (steatoblepharon) in May 2014.  As part of the randomized controlled trials, subjects applied XAF5 Ointment once a night to skin on the lower eyelid.

The therapy’s origins data back to an observation in the Harvard Medical School Department of Ophthalmology that prostaglandin eye drops have a common side effect of reducing fat around the eye, according to Topokine Therapeutics.