Iridex Obtains Regulatory Clearance for Cyclo G6® Glaucoma Platform in China

Rhea-AI Summary

Iridex Corporation (Nasdaq: IRIX) announced regulatory clearance from China's National Medical Products Administration to market its Cyclo G6® platform for glaucoma treatment. Set to launch in Q3 2022, the Cyclo G6 system, utilizing MicroPulse Transcleral Laser Therapy, aims to address the significant glaucoma issue in China, where an estimated 9.4 million adults suffer from Glaucomatous Optic Neuropathy. This clearance marks a pivotal opportunity for Iridex to expand awareness and adoption of its innovative solutions in a large market.

Positive

• Regulatory clearance in China opens a lucrative market for the Cyclo G6 platform.
• Potential to address the healthcare needs of millions suffering from glaucoma in China.

Negative

• None

MOUNTAIN VIEW, Calif., June 14, 2022 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a provider of innovative ophthalmic laser-based medical products for the treatment of glaucoma and retinal diseases, today announced that it has received regulatory clearance to market and sell its Cyclo G6^® platform for the treatment of glaucoma diseases in China by its National Medical Products Administration (NMPA). In accordance with the clearance, Iridex and distribution partners Topcon and Clinico will launch the Cyclo G6 system and related probes in China beginning in the third quarter of 2022.  

“Achieving regulatory approval in China is an important milestone for Iridex and opens a large market for MicroPulse Transcleral Laser Therapy (TLT) and our non-incisional treatment suite. We are pleased to to offer these unique solutions to the large population suffering from glaucoma diseases throughout China,” said David Bruce, President and CEO of Iridex. “This market clearance provides us with a significant new market to drive further awareness and adoption of the Cyclo G6 platform throughout the world.”

The Cyclo G6 system utilizes the company’s MP3 Probe to deliver its MicroPulse TLT, providing non-incisional IOP control in a quick, effective and safe procedure. A study in the Journal of Glaucoma found 2% to 4% of adults over the age of 40 in China suffer from glaucoma¹. A study in the British Journal of Ophthalmology determined that among China’s 405 million adults over 40 years old, there are approximately 9.4 million adults with Glaucomatous Optic Neuropathy (GON). Approximately 5.2 million Chinese citizens are blind in at least one eye and 1.7 million of these patients are blind in both eyes resulting from GON.²

About Iridex
Iridex is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices, and consumable instrumentation for the ophthalmology market. The company’s proprietary MicroPulse^® technology delivers a differentiated treatment that provides safe, effective, and proven treatment for targeted sight-threatening eye conditions. Iridex’s current product line is used to treat glaucoma and diabetic macular edema (DME), and other retinal diseases. Iridex products are sold in the United States through a direct sales force and internationally, primarily through independent distributors into more than 100 countries. For further information, visit the Iridex website at www.iridex.com.

Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, including those statements concerning clinical and commercial plans, and the market opportunity, demand for and utilization of the Company's products. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the fiscal quarter ended May 12, 2022.

Investor Relations Contact
Hunter Cabi
investors@iridex.com

_______________________________
¹ https://journals.lww.com/glaucomajournal/fulltext/2019/11000/the_chinese_glaucoma_study_consortium_for_patients.6.aspx#:~:text=Aim%3A,medical%20practice%20for%20glaucoma%20patients [journals.lww.com]
² https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1723754/pdf/v085p01277.pdf [ncbi.nlm.nih.gov]

FAQ

What is the significance of the regulatory clearance for Iridex Corporation's Cyclo G6 platform in China?

The regulatory clearance allows Iridex to market its Cyclo G6 platform for glaucoma treatment, significantly expanding its market reach in China.

When will Iridex launch the Cyclo G6 system in China?

Iridex plans to launch the Cyclo G6 system in China beginning in the third quarter of 2022.

How many adults in China suffer from glaucoma?

Approximately 9.4 million adults over 40 in China have Glaucomatous Optic Neuropathy, according to studies.

What therapy does the Cyclo G6 platform utilize for glaucoma?

The Cyclo G6 platform uses MicroPulse Transcleral Laser Therapy for effective glaucoma treatment.

What is the stock symbol for Iridex Corporation?

The stock symbol for Iridex Corporation is IRIX.