FDA Approves Novaliq’s New Drug Application for Treatment of Dry Eye Disease

Novaliq announced that the FDA has approved CyclASol (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory drug for the treatment of the signs and symptoms of dry eye disease.

The agency completed the filing review of the CyclASol NDA and determined that the application is sufficiently complete to permit a substantive review. At this moment, no potential review concerns have been found. The FDA has set a June 8, 2023 deadline for taking an official position on Novaliq's NDA following evaluation of the application under the Prescription Drug User Fee Act (PDUFA).

“This is an exciting time for ophthalmologists and optometrists and their patients as we are one step closer to address important needs and to better treat a serious ocular surface condition affecting millions of Americans,” Christian Roesky, PhD, CEO, Novaliq, said in a company news release. “If approved, CyclASol would be a highly potent but comfortable anti-inflammatory therapy for patients with dry eye disease. It shows impressive and rapid therapeutic effects objectively measured on the ocular surface in the majority of patients, with clinical benefits on the signs and symptoms of the disease.”

According to Novaliq, CyclASol has been shown in two key studies to have a rapid onset of therapeutic activity in patients with this indication, clinically significant alleviation of ocular surface damage, and great tolerability. For the majority of the sign and symptom endpoints, the effects are maintained and in some cases even improved, according to results from 12-month long-term research.

“This important milestone marks the second NDA acceptance of water-free dry eye therapies in less than 3 months.¹ The two distinct modalities of action of the EyeSol-based dry eye therapies open new and complimentary clinical prospects on how to treat DED in the future,” said Sonja Krösser, PhD, Vice President Preclinical & Clinical Development at Novaliq. “We are committed to work closely with the FDA to bring this novel cyclosporine drug product to patients suffering from DED as quickly as possible.”

In 2023, Novaliq also intends to file a marketing authorization request to the European Medicines Agency and other regulatory bodies.

References

1. https://www.novaliq.com/press-releases/2022/09/07/fda-accepts-nda-filing-for-nov03/

Source: Novaliq