SYD-101 Faces FDA Rejection, Casting Uncertainty on Potential Treatment for Diabetic Retinopathy
WASHINGTON – The FDA has issued a Complete Response Letter (CRL) to Syneos Health, Inc. regarding its New Drug Application (NDA) for SYD-101, an investigational therapy intended to treat diabetic retinopathy, the companies announced today. The decision halts the potential near-term availability of a novel treatment option for a leading cause of vision loss.
The CRL cites deficiencies requiring further study before approval can be considered, impacting syneos Health and, more significantly, the millions living with diabetic retinopathy.diabetic retinopathy affects an estimated 4.2 million adults in the United States, according to the Centers for Disease Control and Prevention, and is a major complication of diabetes. The non-approval underscores the rigorous standards of the FDA and introduces new timelines for a therapy previously viewed as promising.
SYD-101 is a sustained-release intravitreal implant designed to deliver a corticosteroid directly to the eye, aiming to reduce inflammation and prevent vision loss. Clinical trials, including the Phase 3 ARCHES study, demonstrated statistically important improvements in vision compared to placebo. Though, the FDA has requested additional data related to the manufacturing process and long-term safety profile of the implant.
“We are disappointed with the FDAS decision and are working diligently to understand the specific concerns raised in the CRL,” saeid a Syneos Health spokesperson. “We remain committed to bringing SYD-101 to patients who may benefit from this innovative treatment.”
The companies plan to meet with the FDA to discuss the path forward and determine the necessary steps to address the deficiencies. This process coudl involve conducting additional clinical trials or providing further manufacturing data,perhaps delaying the drug’s availability for several years.
Experts emphasize the importance of continued research and progress in diabetic retinopathy treatment. Current treatment options include laser therapy, injections of anti-VEGF drugs, and vitrectomy surgery. SYD-101 offered a potential option with a longer-lasting effect, reducing the frequency of injections. The FDA’s decision highlights the challenges in bringing new therapies to market, even those demonstrating clinical benefit.
