RecensMedical's OcuCool, a cooling ocular anesthetic device designed for intravitreal injections, has received FDA De Novo approval, marking a significant advancement in retinal disease treatment. The device aims to reduce pain, minimize irritation, and decrease procedure time, addressing the common anxieties associated with eye injections.
Clinical Trial Insights
Clinical trials have demonstrated that patients overwhelmingly prefer OcuCool over traditional anesthesia methods. Dr. Arshad M. Khanani, director of clinical research at Sierra Eye Associates and a clinical trial participant, noted that while some patients initially reported mild pain, the faster recovery and lack of irritation the following day made it worthwhile. "I tell my patients they might feel a slight increase in pain with OcuCool, but they’ll thank me the next day: no irritation, faster recovery. For them, it’s worth it," he stated.
Patient Comfort and Reduced Anxiety
According to Kim Gun-ho, CEO of RecensMedical, a significant benefit reported by patients is the quicker return to normal life. The device reduces exposure to betadine and the use of traditional anesthetics, leading to reduced pre-procedure anxiety. Surveys indicated that 80% of patients preferred OcuCool, highlighting the reassurance provided by the cooling approach, especially for those with fears of delayed anesthetic onset.
Pain Reduction and Efficiency
OcuCool minimizes side effects such as lingering numbness from lidocaine injections or dryness from gels. Clinical trials reported pain levels between 0 and 2 on a 10-point scale, significantly lower than the 3 to 5 reported with eye drops or gels. The device uses thermoelectric cooling to numb the eye in about 50 seconds, replacing the traditional 10–15-minute preparation time. This efficiency allows clinics to handle more cases daily, alleviating strain on overcrowded practices.
Addressing Market Challenges
Despite its FDA approval, RecensMedical faces challenges in Korea due to the country's rigid and underfunded healthcare reimbursement system. Intravitreal injections, including anesthesia, are reimbursed at approximately $150 in Korea, significantly less than in the U.S. To overcome these hurdles, RecensMedical plans to initially offer OcuCool under a cash model in the U.S. market, leveraging its low manufacturing costs to compete with existing anesthesia options.
