An FDA advisory panel recently gave a green light to Balance Ophthalmics Inc to continue studies of their Fsyx Ocular Pressure Adjusting Pump (Fsyx OPAP) as a potential treatment for open-angle glaucoma.
The Fsyx OPAP is a pair of goggles that create negative pressure inside the space between the goggles and the patient's face. The goggles are intended to be worn at night to help reduce intraocular pressure (IOP) for patients with an IOP which is less than or equal to 21 mmHg. The Fsyx OPAP gives 12 hours of non-stop negative pressure therapy when worn and data is transmitted to the prescribing doctor.
Initial study results of the device provided by the company found that 58.1% of the eyes of the patients involved in the study demonstrated a 20% drop in IOP compared to only a 1.1% drop in untreated eyes.
The FDA advisory panel expressed a desire for the company to show clinical benefit as well as the need to determine the impact of the therapy on retinal nerve fiber layer and visual fields. Data from patients aged 65 years and up also need to be included in future clinical studies due to the prevalence of glaucoma in this age group.
