COSTA MESA, Calif.,/IReach-PRNewswire/–WCCT Global, a full-service CRO specializing in ophthalmology clinical research, is pleased to announce its continued involvement in a late phase clinical trial of a novel treatment for a condition known as steatoblepharon, alongside pharmaceutical development company Topokine Therapeutics. Last year, WCCT Global’s Medical Director of Ophthalmology Clinical Research, Dr. Michael Sheety, presented successful results from the trial at the American Academy of Dermatology’s annual meeting, during their “Late Breaking Research” session. The condition, commonly referred to as “eye bags,” affects over 90 million Americans, has until recently only had one available treatment—blepharoplasty—which is a surgical treatment which involves pain, bruising, and risks to the eyes and vision. Thus, a successful result from an ophthalmology clinical trial testing a novel treatment for the condition is of particular importance.
Because of the successful results of the Phase 2 trial this past year, Topokine has announced further research of the treatment in a Phase 2b/3 trial, in which WCCT Global will continue their involvement in this ophthalmology clinical research program. The Phase 2b/3 trial will employ similar primary endpoints as the late phase program last year, in which over 50% of the study subjects showed a bilateral improvement of at least 1 point on the 5 point Lower Eyelid Steatoblepharon Severity scale. Additionally, 85% of subjects participating in the study reported a positive response to the effects of the novel treatment, an ointment labeled XAF5, Furthermore, in a recent global survey, 6,000 consumers identified “eye bags” as the number one area of concern in facial appearance. Further surveys reported that 80% of dermatologists and 70% of plastic surgeons said they were likely to prescribe Topokine’s novel treatment.
When asked about the ophthalmology research program, Dr. Michael Sheety had this to say: “The results of last year’s program were exciting to present, and I am pleased to know that WCCT Global will be a part of the ongoing ophthalmology clinical trial for this treatment. Being that this is the first scientifically proven, non-invasive therapy to rejuvenate the eye area, this treatment has the potential to change the landscape of medical aesthetics in a very positive way. WCCT is eager to begin work on this program and further contribute to ophthalmology clinical research and advances in cosmetology.”
About WCCT Global
WCCT Global is a multi-site, full service CRO of outsourced early drug development and late phase CRO services to the pharmaceutical, biotechnology and medical device industries. The WCCT Global vision, “With compassion for people, we strive for tomorrow’s therapies to be available today” truly exemplifies the focus and reason for our cutting edge work both in our clinics and throughout our operations. As a drug development partner, WCCT Global collaborates with domestic and foreign innovator companies who need regulatory, program management, patient recruitment, data management and strategic consulting support, with an emphasis on overseeing and executing trials in special disease populations, pediatric populations, ethno-bridging, and cardiac safety. WCCT has extensive experience with healthy volunteer studies including First-in-Human (FIH), as well as specific therapeutic expertise in Allergy, Asthma, HCV, Ophthalmology, Renal, and Vaccines.
Topokine is a clinical-stage biotechnology company developing topical prescription medications that act pharmacologically on adipocytes to contour the face and body. The company’s lead program, XAF5 Ointment, is in late-stage clinical development for reduction of excess eyelid fat (steatoblepharon) and other indications. Topokine’s pipeline also includes TAT4 Gel, which increases subcutaneous fat and is entering Phase 2 development as a “topical filler” for reduction of laugh lines (nasolabial folds). The company’s assets are protected by over 75 issued and pending patents worldwide.