RetinalGeniX IRB Approved to Conduct Study to Personalize Medical Evaluations for Patients Receiving Treatment for Wet Macular Degeneration

Rhea-AI Summary

RetinalGeniX Technologies Inc. has announced the launch of an Institutional Review Board for research on its DNA/GPS program. The study aims to identify hematology biomarkers that may help personalize medical evaluations for patients undergoing treatments for wet macular degeneration. The company's goal is to determine if a patient with active exudative AMD will respond better to intravitreal aflibercept versus intravitreal bevacizumab. The study has the potential to reduce costs and improve the safety and efficacy of patient candidate selection for ocular injections.

Positive

• The study has the potential to reduce costs and improve the safety and efficacy of patient candidate selection for ocular injections.

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• None.

Study Intends To Identify Hematology Biomarkers That May Help Personalize Medical Evaluations For Patients Undergoing Treatments For Wet Macular Degeneration

PETALUMA, Calif., Oct. 30, 2023 (GLOBE NEWSWIRE) -- RetinalGeniX™ Technologies Inc. (OTCQB:RTGN) (“RetinalGeniX” or the “Company”), today announced the launch of an Institutional Review Board (“IRB”) for research on its DNA/GPS program.

The study aims to offer recommendations for enhancing the preselection process and management of ocular injections.

The proposed patient selection process has the potential to reduce the cost and improve the safety and efficacy of patient candidate selection for ocular injections. These factors represent significant challenges associated with wet macular degeneration-related vision loss.

“RetinalGeniX DNA/GPS has submitted a study with Pearl IRB to perform a clinical review of 390 patients. The company’s goal is to elucidate blood biomarkers to determine if a patient with active exudative AMD will respond better to intravitreal aflibercept versus intravitreal bevacizumab, two of the most used anti-VEGF agents available for treatment today. This research might lay the groundwork for ophthalmic personalized medicine that may be done with a simple blood test,” said Dr. Larry Perich, Director of the DNA/GPS program at RetinalGeniX. Dr. Perich will lead the collaborative study among leading universities to identify hematology biomarkers.

Jerry Katzman, MD, the CEO of RetinalGeniX, emphasized the importance of limiting ocular anti-VEGF injections into patients’ eyes for those who are good candidates for responsive treatment.

“Administering ineffective treatments is not only costly to the healthcare system, insurance carriers, and patients, but may also cause discomfort, stress, and unnecessary risk. Developing a simple blood test that can predict the likelihood of treatment success would greatly benefit everyone involved. Thanks to the advancements in pharmacogenetic mapping, studies such as Anti-VEGF are now possible, and a new era of "Precision Medicine" holds great promise for the future,” stated Dr. Katzman

In Ocular Surgery News on September 25, 2023, Dr. Richard Lindstrom stated, “We will approach 8 million intravitreal injections in 2023 and may hit 10 Million by 2025."

According to the BrightFocus Foundation and JAMA Ophthalmology, approximately 20 million people in the United States have AMD, and nearly 1.5 million Americans have the advanced form of the disease.

About RetinalGeniX™

RetinalGeniX is an ophthalmic research and development company focused on developing technologies for the early detection and treatment of ocular diseases as well as neurodegenerative, cardiovascular, vascular, metabolic, and diabetic conditions.

RetinalGeniX is developing innovative technologies such as DNA/RNA/GPS™ Pharmaco-Genetic Mapping™ software, which will be accessible to patients through an application, and will provide bio-marker information to aid in drug development. Additionally, RetinalGeniX is developing a high-resolution retinal home monitoring system that will offer real-time alerts to both physicians and patients and a cost-effective high-resolution retinal mass screening device that captures a 200° field of view without the need for dilation of the pupil.

Safe Harbor Statement

This press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of the words “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project” and similar expressions that are intended to identify forward-looking statements and include statements regarding the Company’s retinal screening medical device technology helping prevent blindness and multiple systemic diseases, the Company’s webinar greatly enhancing the understanding of the importance of combining genetic markers and high-resolution retinal imaging in the treatment disease and developing technologies to diagnose and treat systemic disorders by combining high-resolution imaging, pharmacogenetic portal software, and diagnostic testing all based on data to be obtained from the RetinalGeniX DNA/RNA GPS platform and related test kits. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements.

Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to develop technologies to diagnose and treat systemic disorders by combining high-resolution imaging, pharmacogenetic portal software, and diagnostic testing based on data obtained from the RetinalGeniX DNA/RNA GPS platform and related test kits, and the risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contact

RetinalGeniX Technologies Inc. Jerry Katzman, MD, CEO
jkatzman@retinalgenix.com
+1 (415) 578-9761
www.retinalgenix.com

FAQ

What is the purpose of RetinalGeniX's study?

The purpose of the study is to identify hematology biomarkers that may help personalize medical evaluations for patients undergoing treatments for wet macular degeneration.

What is the goal of RetinalGeniX's DNA/GPS program?

The goal of the DNA/GPS program is to determine if a patient with active exudative AMD will respond better to intravitreal aflibercept versus intravitreal bevacizumab.

What potential benefits can the study bring?

The study has the potential to reduce costs and improve the safety and efficacy of patient candidate selection for ocular injections.

How many patients will be included in the clinical review?

The clinical review will include 390 patients.

How many intravitreal injections are projected to be administered in 2023?

Approximately 8 million intravitreal injections are projected to be administered in 2023, with a potential increase to 10 million by 2025.

How many people in the United States have AMD?

Approximately 20 million people in the United States have AMD.

How many Americans have the advanced form of AMD?

Nearly 1.5 million Americans have the advanced form of AMD.