Heidelberg, Germany – October 2, 2017 – The German Ophthalmological Society (DOG) presented Uta Gehlsen, PhD, Ocular Surface Group, Department of Ophthalmology, University of Cologne, with the “Dry Eye and Blepharitis/MGD” Award for her research related to the use of a semifluorinated alkane (SFA F4H5) as a novel carrier for cyclosporine A for the topical treatment of dry eye disease (DED).1
The DOG Awards recognize scientific and academic excellence, the advancement of young researchers, interdisciplinary and internationality in the field of ophthalmology. Sponsored by Optima Pharmazeutische GmbH, the award was presented on Saturday, September 30, 2017 during the 115th DOG Congress in Berlin.
Dr. Gehlsen’s research, which was published in Graefe’s Archive for Clinical and Experimental Ophthalmology in January 2017, found that a cyclosporine A formulation using F4H5 as its vehicle (CyclASol®, Novaliq) was equally effective but had a significantly faster therapeutic response in reducing the signs of DED compared to a commercially available treatment in an experimental mouse model.
Topical cyclosporine is a well-established medication used to treat signs of DED. It has anti-inflammatory effects and prevents T-cell activation. Clinical studies have shown that it is effective in reducing corneal staining and/or increasing tear production. Cyclosporine is also a highly lipophilic substance typically formulated as an emulsion which often causes adverse side effects with burning and stinging sensations due to the involved surfactants. The premise of the study was to learn whether a new SFA drug delivery system may improve efficacy or tolerability of cyclosporine.
“It is an honor to have been recognized by the DOG for our work in the area of SFA drug delivery technology and dry eye disease”, said Dr. Gehlsen. “Using the desiccating-stress dry-eye mouse model enables us to perform highly standardized pre-clinical in-vivo testing of topical therapies for inflammatory dry eye disease. Our experimental studies with several cyclosporine formulations hereby demonstrated a significantly faster and equally effective topical treatment effect for CyclASol® compared to other commercially available products. I am very pleased that our experimental results for CyclASol® have now been confirmed in the CYS-002 multicenter US clinical trial and hopefully will be soon available to treat patients suffering from dry eye disease.”
In this pre-clinical study, 0.05% cyclosporine dissolved in the F4H5 (CyclASol®) was found to be highly effective in reducing corneal staining and increasing tear production. Compared to the commercially available therapy comparator group, CyclASol® demonstrated at least a comparable therapeutic effect, but with a significantly faster response. Notably, early therapy with CyclASol® protected mice from developing dry eye, whereas all other study groups showed a significant increase of staining compared to baseline. CyclASol® also was the only studied treatment that demonstrated a prophylactic effect.
“On behalf of Novaliq, I congratulate Dr. Gehlsen for being presented with this award by the prestigious German Ophthalmological Society,” said Christian Roesky, PhD, managing director and CEO, Novaliq GmbH. “Through their research, we are better able to understand the many benefits of the SFA vehicle when added to traditionally insoluble or unstable drugs such as cyclosporine. Equipped with this knowledge, Novaliq has developed a very exciting and robust dry eye pipeline that has the potential to address significant unmet medical needs.”
About CyclASol® – CyclASol® is a clear, preservative-free ophthalmic solution of cyclosporine A formulated using Novaliq’s proprietary EyeSol® drug delivery technology.
About Novaliq – Novaliq GmbH, founded in 2007, is a Heidelberg based specialty pharmaceutical company focused on ophthalmology. Its mission is to transform poorly soluble drugs into effective ocular therapeutics for both the front and the back of the eye. Novaliq’s proprietary EyeSol® technology enhances the topical bio-availability, stability and safety of traditionally insoluble or unstable drugs improving the delivery, efficacy and convenience of treatments for ocular surface diseases including dry eye through preservative free and multi dose formulations. Novaliq has developed a tiered and long-term sustainable dry eye family of truly differentiated products that addresses the different needs of dry eye patients. Novaliq’s most advanced product is NovaTears® with CE-approval marketed under the brand name EvoTears® in Europe. CyclASol® a second-generation prescription drug is currently in preparation for a pivotal trial.
About German Ophthalmological Society (DOG) – The DOG is the medical scientific association of ophthalmology in Germany and besides the oldest ophthalmological association in the world. It unites more than 7,000 ophthalmologists in hospitals, medical and research units. One of its main scopes is to advance scientific progress in ophthalmology and to transfer acknowledged findings into the daily routine in clinics and physicians’ practices.
1) Gehlsen U, Braun T, Notara M, Krösser S, Steven P; A semifluorinated alkane (F4H5) as novel carrier for cyclosporine A: a promising therapeutic and prophylactic option for topical treatment of dry eye; Graefes Arch Clin Exp Ophthalmol 2017; 255(4): 767-775