FDA Accepts NDA for Novaliq’s New Dry Eye Therapy

The FDA has accepted the new drug application for Novaliq’s CyclASol (cyclosporine ophthalmic solution), to treat the signs and symptoms of dry eye disease (DED). The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA is June 8, 2023.

Christian Roesky, Ph.D.

“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,” Christian Roesky, Ph.D., CEO, Novaliq said in a press release.

Novaliq submitted the NDA for CyclASol in August 2022, and the application was based on two pivotal studies in more than 2,000 patients. The trials that showed CyclASol delivered a fast onset of therapeutic effect in afflicted patients in this indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining (tCFS) score favoring CyclASol in both studies at days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement

Additionally, results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints. The most common adverse reaction observed was instillation site reactions, which was reported in 8.1% of patients in the pooled studies. These were in all but one case mild.

CyclASol is water-free, preservative-free solution based on EyeSol technology. Cyclosporine is not water-soluble, but the EyeSol excipient perfluorobutylpentane allows for improved bioavailability and better efficacy on the target tissue. The product contains no oils, no surfactants and is preservative-free due to the novel carrier. This provides additional clinical benefits for patients, such as improved tolerability and decreased visual disturbances.

Dry eye is one of the most common ocular surface disorders, with about 18 million Americans diagnosed with dry eye disease. Inflammation and immunologic processes play a key role in the pathology of the disease.

Related: FDA Accepts NDA for Novel Dry Eye Disease Therapy

Additionally, the company’s NOV03 is under FDA review for dry eye associated with Meibomian gland dysfunction (MGD), which is a major cause of the development and progression of evaporative dry eye disease. It caused by a deficient tear film lipid layer that leads to increased tear evaporation. NOV03 uses the same EyeSol technology. Bausch + Lomb licensed NOV03 in December 2019.