Nova Eye Medical Limited Announces New, Additional Clinical Application for 2RT Currently Under Investigation
January 24, 2023 at 04:16 pm EST
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Nova Eye Medical Limited announced that investigator-initiated studies have commenced to address the safety and effectiveness of the Company's world-first 2RT® subthreshold nano pulse laser for central serous retinopathy or CSR. If successful, these studies would underpin a new market
opportunity for 2RT® in the treatment of CSR, valued at USD 60 million per year. This would be in addition to the previously stated market opportunity for 2RT® in the treatment of AMD, which is valued at USD 600 million per year. The unique method of action of 2RT® that stimulates rejuvenation of the retinal pigment epithelium (RPE)1,4, makes therapy with 2RT® potentially better for patients with CSR. Central serous retinopathy is the fourth most common retinal disease after age-related macular degeneration, diabetic eye disease and branch retinal vein occlusion. It occurs when fluid
builds up under the retina, resulting in sudden central vision loss or distortion. According to the American Academy of Ophthalmology (AAO), males in their 30s to 50s are more likely to develop CSR. Approximately 10 per 100,000 males are impacted by CSR2. Chronic and untreated CSR has been shown to result in progressive damage to the retina. According to the published literature, current treatment options for CSR are primarily limited
to thermal laser therapy and photodynamic therapy. Despite offering good efficacy, these treatment options carry a high-risk profile: thermal lasers have been shown to cause permanent damage to the retinal pigment epithelium (RPE), an important layer of cells in the retina, while photodynamic therapy may have unfavourable side effects. The two investigator-initiated studies to assess the clinical utility of 2RT® in the treatment of
CSR are currently underway in Toronto, Canada and Melbourne, Australia. The study in Australia is being supported with equipment supplied by AlphaRET Pty Ltd, the wholly owned subsidiary of Nova Eye Medical responsible for commercialising 2RT. The first study, being conducted by Shaheer Aboobaker, MD and David Chow, MD, Toronto Retinal Institute, will investigate the role of 2RT® for acute CSR. To date, 25 patients have
been recruited in the study. The second study, being conducted by Mali Okado MBBS, BMedSci, MMed, Centre for Eye Research Australia (CERA) and Professor Wilson Heriot MBBS, FRANZCO, Retinology Institute Glen Iris, Victoria, Australia, will investigate the role of 2RT® for acute chronic CSR.
To date, 10 patients have been recruited in the study (ClinicalTrials.gov Identifier: NCT05570591).
Nova Eye Medical Limited is an Australia-based medical technology company. The Companyâs principal activities include the design, development, manufacture, marketing, sale, and distribution of surgical devices for the treatment of glaucoma, a cause of blindness. The Company is also engaged in the commercialization of its ophthalmic laser, 2RT. The Companyâs segments include AlphaRET and Glaucoma surgical devices. The Company's AlphaRET segment has 2RT, which is an ophthalmic laser developed for the therapy of patients in the early to intermediate stages of age-related macular degeneration (AMD). 2RT is a patented nano-pause laser device that rejuvenates retinal structures compromised by AMD. The Glaucoma Surgical Devices segment includes the design, manufacture, marketing and sale of the iTrack, iTrack Advance, and the Molteno3 glaucoma surgical device. The Company's manufacturing facilities are located in Fremont, California, and Dunedin, New Zealand.
NOVA EYE MEDICAL LIMITED 
