Nova Eye Medical : Establishes AlphaRET Pty Limited to Support the Commercial Development of 2RT®

ASX RELEASE

Nova Eye Medical Establishes AlphaRET Pty Limited to Support the Commercial Development of 2RT®

Adelaide, Australia, 26 October 2020 - Nova Eye Medical Limited (ASX: EYE)(Nova Eye Medical or the Company), a medical technology company committed to advanced ophthalmic treatment technologies and devices, today announces the establishment of AlphaRET Pty Ltd (AlphaRETTM) to support the commercial development of its 2RT® asset.

2RT® is the Company's proprietary minimally invasive nano-pulse ophthalmic laser therapy which, in the 2018 Phase 2 "LEAD" clinical study, demonstrated efficacy in a subset of patients in the treatment of intermediate age-related macular degeneration (iAMD).

The establishment of AlphaRET, a wholly owned subsidiary of Nova Eye Medical Limited, will enable the Company to focus its development activities for 2RT®. It also clearly delineates the 2RT® project from the Company's core business, which is focused on glaucoma treatment technologies.

2RT® is based on seminal laboratory investigations performed by world-renowned retinal expert Prof. John Marshall PhD, FRCPath, FMedDSci (Institute of Ophthalmology, University College London, UK). Prof. Marshall is actively involved in the 2RT® project and is a Board member of AlphaRET.

According to Prof. Marshall 2RT® represents a huge step forward in the treatment of AMD, which is one of the world's leading causes of blindness. To date, no treatment exists for the disease in its early stages.

"2RT® is arguably the most significant advance in AMD since anti-VEGF therapy used for the late stage of the disease known as Wet AMD. It is estimated that 30% of patients over 60 have some form of AMD and over 10% of this population will go on to lose some part of their vision from the late forms of this disease. 2RT® is a significant breakthrough in the potential management of patients with high risk earlier stage of the disease known as intermediate AMD."

Commenting on the establishment of AlphaRET, Director of Nova Eye Medical, Mr. Spurling said: "2RT® is a major project and offers the potential to meet a substantial unmet market need. Our core business remains firmly focused on glaucoma, underpinned by our proprietary iTrack™ and Molteno3® technologies. With the establishment of AlphaRET we will be able to better leverage the 2RT® opportunity, while continuing to support the growth of our glaucoma treatment technology pipeline under the Nova Eye Medical brand."

In the immediate term AlphaRET will prioritise the USA regulatory pathway for 2RT®, which includes the filing of an Investigational Device Exemption (IDE) with the US Food and Drug Administration (FDA) for a major clinical study. The aim of the study will be to provide statistically significant clinical evidence that 2RT delays the progression on iAMD and thereby obtain clearance from the FDA to treat patients

│ Nova Eye Medical Limited │ ACN 007 702 927 │107 Rundle Street, Kent Town, SA 5067 │

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with iAMD.

"We are currently finalizing discussions with the FDA on the IDE and study. In parallel we will be engaging with potential commercialization partners," added Mr. Spurling.

A summary of AlphaRET and the 2RT® opportunity is attached.

This release dated 26 October 2020 has been authorised for lodgement to ASX by the Board of Directors of Nova Eye Medical Limited and lodged by Simon Gray, Company Secretary.

- ENDS -

For further information please contact:
Company	Investors
Tom Spurling	Dr. Tom Duthy
Director	Investor Relations & Corporate Development
Nova Eye Medical Limited	Nova Eye Medical Limited
[e-mail]	W [phone]
	[e-mail]
Media
Kate Hunt
Head of Marketing
Nova Eye Medical Limited
W [phone]
[e-mail]

ABOUT 2RT

2RT® is a proprietary, patented laser therapy that stimulates a biological healing response in the eye to treat the intermediate stages of age-related macular degeneration (AMD) and Clinically Significant Macular Edema (CSME). Current research suggests that 2RT® stimulates a natural immune response of the retina, which restores natural metabolite flow and rejuvenates the retinal pigment epithelium- without damage to the overlying neurosensory retina (specifically, no damage is caused to the photoreceptors) or the underlying Bruch's membrane. Importantly, 2RT® offers the potential to intervene earlier in the disease process and thereby eliminate or delay the risk of vision-threatening complications associated with AMD - offering a breakthrough approach to the management of AMD patients. 2RT® has also been shown to be as effective as photocoagulation in reducing the pathology associated with CSME, but with the additional benefit of eliminating thermal damage to the neuroretina.

Ellex 2RT® Approved Indications of Use

CE MARK:

• The treatment of Clinically Significant Macular Edema (CSME); and

│ Nova Eye Medical Limited │ ACN 007 792 927 │ 107 Rundle Street, Kent Town, SA 5067 │

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• In patients with early Age-related Macular Degeneration (AMD) where it can produce bilateral improvements in macular appearance and function.

US 510(k):

• The treatment of Clinically Significant Macular Edema (CSME).

ABOUT THE LEAD TRIAL

The Laser Intervention in Early AMD (LEAD) Trial, a large randomized, controlled clinical trial, demonstrated the potential for 2RT® to significantly reduce the rate of disease progression in a specific group of intermediate AMD patients. The study, which enrolled 292 patients, examined whether treatment with 2RT® could delay progression of intermediate AMD to late-stage disease. Each participant was randomly assigned to 2RT® treatment (2RT® Group), or a sham laser treatment (Sham Group) and received treatment and/or follow-up over three years. Despite not reaching statistical significance, when considering all patients enrolled in the trial, there was a trend to delay progression from early to late stage AMD in those treated with 2RT®. Post hoc analyses showed that in patients who did not have coexistent reticular pseudodrusen (RPD), a fatty deposit that is associated with later stages of AMD (76% of patients enrolled), treatment with 2RT® resulted in a clinically meaningful 77% reduction in the rate of disease progression.

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 glaucoma. It also offers the benefit of a simplified and faster surgical procedure. With its sales headquarters based in Fremont, California, Nova Eye Medical is supported by 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

│ Nova Eye Medical Limited │ ACN 007 792 927 │ 107 Rundle Street, Kent Town, SA 5067 │

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AlphaRET Pty Ltd is a wholly owned subsidiary of Nova Eye Medical (ASX:EYE)

Commercial arm to facilitate development of the Company's proprietary 2RT® Project