Long-Term Efficacy and Safety of iTrack MIGS Procedure to be Spotlighted at ESCRS 2020

Fremont, California, 2 October 2020 - Nova Eye Medical Limited, a medical technology company committed to advanced ophthalmic treatment technologies and devices, is pleased to report the results of a retrospective case series by German glaucoma surgeon and canaloplasty expert Prof. Norbert Koerber, which demonstrates the efficacy and safety of the Company's proprietary iTrack canaloplasty technology over a 48-monthfollow-up period.

The unpublished case series data will feature as part of the official scientific program at the virtual meeting of the European Society of Cataract and Refractive Surgery (ESCRS), October 2-4, 2020, and parallels the Company's establishment of Nova Eye Medical GmbH, its wholly owned German sales subsidiary.

An internationally renowned glaucoma surgeon and one of the pioneers of the canaloplasty procedure, Prof. Koerber has been using the iTrack in clinical practice for nearly two decades for the treatment of severe glaucoma. In these patients, iTrack is performed via an ab-externo approach to reduce IOP and patient reliance on anti- glaucoma medications. Importantly, iTrack has been shown to defer or eliminate the need for invasive surgical options such as trabeculectomy, which can cause a number of challenges for patients.

Recently, Prof. Koerber has augmented his glaucoma treatment paradigm to include the utilization of iTrack via an ab-interno approach for cases of mild-moderate glaucoma. This corresponds with the industry-wide adoption of minimally invasive glaucoma surgery (MIGS) procedures, which seek to preserve the conjunctiva and sclera and thereby improve the risk-benefit ratio of glaucoma surgical intervention.

In the case series to be presented at ESCRS 2020, Prof. Koerber analyzed the efficacy and safety outcomes of 23 eyes that underwent iTrack ab-interno canaloplasty in conjunction with cataract surgery and 4 pseudophakic eyes that underwent iTrack ab- interno canaloplasty as a standalone procedure.

iTrack was found to be highly effective, maintaining a sustained reduction in IOP from

  1. ± 5.22 mmHg at baseline to 14.0 ± 2.78 mm Hg (n=21), 15.53 ± 2.8 mmHg (n=24),
  1. ± 3.76 (n=22) and 14.25 +-3.11 mmHg (n=11) at 12, 24, 36 and 48 months respectively. iTrack was also shown to reduce patient reliance on medications, with the mean number of medications falling by more than 50% from 1.93 at baseline to 0.9 at 48 months.

Approximately one-third of patients in the case series were categorized as controlled with IOP within target range, and underwent the iTrack procedure due to intolerance to medication.

"Typically, many of my patients experience unwanted side effects from glaucoma medication and often fail to administer the drops as prescribed. For these patients, ab- interno canaloplasty with iTrack offers an early surgical intervention that acts in a similar way to angioplasty to flush out the eye's drainage channel and lower IOP, thus enabling patients to remove the ongoing burden of administering drops."

Commenting on the iTrack data to be presented at ESCRS 2020, Director of Nova Eye Medical, Tom Spurling, said: "Canaloplasty has a rich history in Germany. It was formally recognized in 2014 as the as the new 'gold standard' in the surgical treatment of glaucoma by the patient advocacy group German Federate Eye Association. Since this time the work of Prof. Koerber and colleagues has firmly established the role of canaloplasty as the standard of care for glaucoma surgery."

"We will continue to support the important role of iTrack for ab-externo canaloplasty in Germany, and in the broader European market. The ability of iTrack to achieve the same clinical outcomes as trabeculectomy, but without the unwanted sides effects and bleb-related complications, offers significant benefits to both patients and the broader healthcare system. We will also ramp up our local German infrastructure to support the growing role of iTrack via an ab-interno approach for earlier stage glaucoma," added Mr. Spurling.

Prof. Koerber's ESCRS 2020 iTrack abstract can be accessed via the ESCRS website: https://www.escrs.org/amsterdam2020/programme/free-papers-details.asp?id=36647

ABOUT NOVA EYE MEDICAL

Nova Eye Medical Limited is a medical technology company that develops, manufactures and sells a portfolio of proprietary ophthalmic treatment technologies and devices. Used by eye surgeons in more than 100 countries globally, these technologies include iTrack minimally invasive glaucoma surgery (MIGS), a consumable surgical device that restores the eye's natural outflow pathway to lower pressure inside the eye and to eliminate patient reliance on anti-glaucoma medications for mild-moderate glaucoma. The Molteno3® glaucoma drainage device platform is designed to enhance surgical utility and optimize clinical outcomes for long-term IOP control in cases of severe or complex glaucoma. It also offers the benefit of a simplified and faster surgical profile. With its sales headquarters based in Fremont, California, Nova Eye Medical is supported by sales offices in Adelaide, Australia and Berlin, Germany, and a global network of more than 50 distribution partners. Manufacturing facilities are located in Fremont, California and Dunedin, New Zealand.

For additional information about Nova Eye Medical and its technologies, please visit: www.nova-eye.com

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Kate Hunt

Dr. Tom Duthy

Nova Eye Medical Limited

Nova Eye Medical Limited

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Nova Eye Medical Ltd. published this content on 02 October 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 October 2020 04:19:07 UTC