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Bausch Health licenses Novaliq’s dry eye treatment
Bausch Health has acquired an exclusive license to develop and commercialize Novaliq’s dry eye disease treatment candidate NOV03 in the United States and Canada, according to a press release.
NOV03, a water-free, preservative-free solution that uses Novaliq’s EyeSol technology, addresses dry eye disease associated with meibomian gland dysfunction. A phase 2 study of the drug found improvement inf corneal fluorescein staining over control at 8 weeks and a statistically significant improvement in dry eye symptoms, the release said.
"Bausch Health remains focused on boosting our core businesses, and the addition of this investigational treatment for dry eye disease will help build upon our strong Bausch + Lomb portfolio of integrated eye health products," said Joseph C. Papa, chairman and CEO of Bausch Health. "It is estimated that more than 16 million patients in the United States are diagnosed with dry eye disease, and if approved, NOV03 will be the first pharmaceutical therapy available for patients in the United States suffering from dry eye disease with meibomian gland dysfunction."
Novaliq will receive upfront and milestone payments from Bausch Health based on regulatory and commercial milestones, as well as sales royalties.
"We are thrilled to partner with Bausch + Lomb who is a leader in the ophthalmic space with a strong commercial footprint in the United States and is also very committed to developing innovative new eye health products," said Christian Roesky, PhD, CEO of Novaliq.
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Novaliq's EyeSol technology is a perfluorocarbon eye drop that contains no water. In the form of NOV03, it seems to have the ability to mobilize thickened lipid in meibomian glands and provide symptomatic relief for patients with MGD. The drop size is about one-fifth that of aqueous drops, and the drops spread like an oil slick on the surface of the eye almost immediately, making them very comfortable. Pathogens are seemingly unable to grow in perfluorocarbon solutions, so EyeSol is preservative free. Lastly, because non-polar solutes (like cyclosporine) dissolve readily in it, EyeSol is being evaluated as a vehicle for a number of medications that go well beyond the NOV03 product being licensed by Bausch Health.
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At the moment we do not have an on-label medication to treat MGD. Joe Tauber presented the phase 2 NOV03 data at ASCRS in May and the results are stunning. NOV03 penetrates the meibomian glands and solubilizes meibum, resulting in a durable stabilization of the tear lipid layer. Patients experienced a marked improvement in all types of corneal staining (onset as early as 2 weeks) and a dramatic reduction in classic DED symptoms (eg, 22-point reduction in OSDI on average). Side effects were minimal.
B + L has won what I’ve been told was a spirited competition for NOV03. Is this the right home for what may turn out to be a breakthrough medication and technology (Novaliq also has a cyclosporine A in CyclASol in development)? Of late, B + L seems to be leaving its “gang that couldn’t shoot straight” mantle behind and reclaiming its rightful place among the industry greats. Despite the absence of a presbyopia-correcting IOL, the surgical division has been on fire (Stellaris, enVista toric, etc). On the pharma side, they have two of the premier branded medications in the market (Besivance and Bepreve), and they have marshaled the Lotemax franchise through several stages of development, resulting in another market leader (Lotemax SM).
Like the NFL and the Cowboys, the NCAA and Notre Dame, eye care is better and stronger overall when B + L is healthy. Can they make NOV03 an enVista-like success? I hope so. For all of eye care and for all of our DED patients, I will be cheering them on.
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