CONFERENCE HIGHLIGHTS |
OIS COVERAGE
OIS Dry Eye Innovation Showcase
Making Great Strides in Therapeutics and Technology by Joanna Lee
T
he latest innovations in drugs and devices that ease the sting of dry eye increase opportunities for profit and are pioneering a continuum of care. Dry eye disease (DED) is sometimes taken as seriously as chapped lips. Yet, while 42% of eye care patients (or up to 80 million Americans) have complained of symptoms that indicate DED, only 16 million were diagnosed with DED — and only 1.6 million are being treated. This means that only 5-6% of the U.S. population gets any DED treatment, representing a great opportunity for DED therapeutics. “We’re in the infancy of this,” said Dr. Paul Karpecki, director of cornea services and external disease at the Kentucky Eye Institute, as he moderated the session. Not only that, but Dr. Karpecki also said what was thought of as an “elderly disease” is now changing due to factors like increased time spent on digital devices. The Beaver Dam Offspring Study (BOSS) showed that the prevalence of dry eye in children now matches that of their parents. Women over the age of 65 suffer from DED twice as much as men. However, there doesn’t seem to be a large statistical difference between men and women aged 21-34 when it comes to DED. Dr. Karpecki also revealed that many specialty clinics that treat DED have been doing well with 100% return to profitability, especially during the
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COVID-19 pandemic. “Because their quality of life is affected, they’re more likely to come in,” he said. With much room to make a difference, the Dry Eye Innovation Showcase (by Ophthalmology Innovation Source; OIS) featured eight startups and gave the audience a glimpse into the exciting developments in this growing area of treatment in ophthalmology.
What the market offers The first presentation showcased Novaliq’s unique water-free technology EyeSol®, which overcomes waterbased limitations in eye drops. Out of this technology, Novaliq (Heidelberg, Germany) was able to develop CyclASol®. Its Vice President of Preclinical and Clinical Development Dr. Sonja Krosser revealed CyclASol® has been able to improve cornea damage significantly over Restasis™ by reducing blurred vision and frequency of dryness. One highlight was that the trial’s subjects reported reading speed improvement with corneal staining reduction. The technology’s increased residual time on the eye’s surface, from minutes to hours, also has positive effects on its bioavailability. CyclASol may just fill the gap for the 60% of patients who abandon their treatment due to discomfort. “Its excellent tolerability profile is key for compliance,” she said.
| October 2020
In the area of imaging, Ra’anan Gefen, the managing director of AdOM Advanced Optical Technologies, an Israeli med-tech company, presented a singular device that comprehensively diagnoses DED. The Tear Film Imager (TFI) is currently deemed as the only device that measures muco-aqueous and lipid sublayers simultaneously in nanometer resolution. “A single 40-second automatic non-invasive test provides objective and quantified parameters,” he said. The technology was developed as a result of the understanding that mucus is a barrier for topical ophthalmic drug delivery. Besides its ability to capture measurements in 40 seconds, it has a high frame of more than 10 hertz to capture tear film dynamics (the first in the market to do so), with artificial intelligence capabilities to analyze captured images.
The role of therapeutics Stepping in to combat the mucus barrier for topical ophthalmic drug delivery is Kala Pharmaceuticals (Massachusetts, USA) with its AMPPLIFY® Technology drug delivery system. Its Chief Medical Officer Dr. Kim Brazzell explained how AMPPLIFY delivers drugs using nanoparticles with its proprietary coating to avoid interaction of the drug particles with the mucus. “In the eye, it avoids adhesion to the eye’s tear film mucins, thus enabling rapid penetration through the tear film and enhancing diffusion in the ocular tissues,” Dr. Brazzell said. Significant improvements were seen in both signs and symptoms in the same population during the four trials of this system (primary for phase 2, STRIDE 1, STRIDE 2 and secondary for STRIDE 3). Also, less than 1% reported any IOP elevation, with no serious adverse events observed. AMPPLIFY is targeted for a Q4 2020 launch with the potential to become the first-line therapy for the shortterm treatment of DED, including the treatment of dry eye flares, which occur with the vast majority of dry eye patients.
