Novaliq Announces FDA Acceptance of the NDA for CyclASol® for DED

Novaliq recently announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol® (cyclosporine ophthalmic solution), a firstof-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).

The Agency completed the filing review of the CyclASol NDA and determined that the application is sufficiently complete to permit a substantive review. No potential review issues have been identified at this time. The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA for announcing its decision on Novaliq’s NDA after reviewing the application is June 8, 2023.

“This is an exciting time for ophthalmologists and optometrists and their patients as we are one step closer to address[ing] important needs and

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to better treat a serious ocular surface condition affecting millions of Americans,” said Christian Roesky, CEO of Novaliq.

“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.”

CyclASol has demonstrated in two pivotal studies fast onset of therapeutic effect in afflicted patients in this indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved, for most sign and symptom endpoints.

“This important milestone marks the second NDA acceptance of water-free dry eye therapies in less than three months. 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, VP for Preclinical & Clinical Development at Novaliq. “We are committed to work[ing] closely with the FDA to bring this novel cyclosporine drug product to patients suffering from DED as quickly as possible.”

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

Novaliq further plans to submit a marketing authorization application to the European Medicines Agency and further authorities this year.

Bausch + Lomb and GRF Launch New Glaucoma Awareness Campaign in Recognition of Glaucoma Awareness Month

Bausch + Lomb Corporation and Glaucoma Research Foundation (GRF), a national non-profit organization with the vision of curing glaucoma, recently announced the US launch of ‘Screen, Protect, Cure’ — a campaign designed to provide educational resources and raise awareness of glaucoma, a leading cause of irreversible blindness — during Glaucoma Awareness Month.

“We are proud to collaborate with Glaucoma Research Foundation to provide critical information about this serious eye disease and underline the negative toll it can have if left untreated,” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb. “Glaucoma can affect individuals of all ages and only half of those affected are aware they have it, so it’s important that we share risk factors, how to get tested, and what treatment options are available. Through ‘Screen, Protect, Cure,’ we hope to help support patients in every step of their treatment journey.”

During the month of January, Glaucoma Awareness Month, Bausch + Lomb and GRF shared educational resources to educate individuals who may be at risk for glaucoma and empower them to take an informed and active role in their eye health. The campaign also features a fundraising challenge that will match every dollar raised up to $20,000 in support of GRF research for a potential cure for glaucoma.

“Glaucoma Awareness Month provides a great opportunity to share information about this sight-threatening disease and remind people there are steps they can take to help preserve their vision,” said Thomas M. Brunner, president and CEO of GRF. “Visiting an eye care provider on an annual basis and paying attention to visual function are the best things someone can do to avoid the irreversible damage from glaucoma. Although there is currently no cure, our fight to prevent visual disability is ongoing, and we are grateful for the collaboration of organizations, such as Bausch + Lomb, who share this commitment with us.” For more information, visit glaucoma.org/ screen-protect-cure.