Novaliq has been transforming how clinicians think about artificial tears since the company’s inception, said Bernhard Günther, co-founder and chief executive officer. NovaTears/EvoTears is a first-in-class artificial tear that addresses the lipid layer of the tear film; the tears have been marketed in Europe for more than a year and are on track to be submitted for US and Japanese approval in 2021 and 2018, respectively.
These tears have the same refractive index as water, and stabilize the lipid layer with “excellent spreading, small drops [10 μL], a silky feel, and no blurring,” Günther said.
Introduced as EvoTears in Europe in October 2015, Novaliq and European partner Ursapharm have introduced the tears in 10 countries at around $23.44/bottle. At one year, there have been “mid-six-digit units sold,” Günther stated. Novaliq is looking for partnership opportunities in other geographic regions as well.
The tears are being evaluated in three different populations: mild-to-moderate evaporative dry eye disease (DED), meibomian gland dysfunction (MGD), and severe DED due to ocular graft-versus-host disease (GVHD). In the DED and MGD studies, there has been “significant improvement in signs and symptoms,” Günther said, but in the GVHD study no added benefits were found although the tears demonstrated an excellent safety profile.
The tears are in clinical studies for use after cataract surgery, with one-day contact lenses, and post-LASIK.
EyeSol, the company’s latest platform, “is an innovative formulation of poorly soluble drugs” that should provide improved penetration and higher stability/activity than the original compounds,” Günther said.
Also in the pipeline is CyclASol, a clear, preservative-free ophthalmic solution of cyclosporine in SFA (semifluorinated alkanes), currently in Phase II studies (n = 200) with top-line data expected by January 2017.
Finally, Novaliq is evaluating a combination of NovaTears and omega-3 for the treatment of evaporative DED; registration as a medical device is ongoing in Europe and the company expects to launch the product in late 2017. NovaTears is also in preclinical studies for glaucoma and retinal disorders.
Bernhard Günther joined Novaliq as CEO in January 2007. He has more than 20 years of experience in the field of ocular biopharmaceutics and medical devices.