AiViva Reports That Their Promising New Treatment For Wet AMD Is Soon To Be Ready For Clinical Trials

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Wet age-related macular degeneration, also known as wet AMD, is a chronic eye disorder that causes blurred vision or blind spots in the visual field of the eye. 

It’s caused by abnormal blood vessels that leak fluid or blood into the eye’s macula and scar it (the macula is the area of the eye that provides the sharp, central vision needed for reading, driving and seeing fine detail). Wet AMD can progressively lead to vision loss resulting in permanent blindness if left untreated, according to reports. Over 45% of patients on current therapies do not achieve meaningful vision gain. Currently, there is no cure for wet AMD.

Currently, available treatment for wet AMD involves frequent injections in the eye. It can be a drawn-out process that takes anywhere from four to 12 weeks so 

new product development for wet AMD is focused on developing longer-acting effective drugs, which could result in better vision preservation and less frequent trips to the doctor.

AiViva BioPharma, a clinical-stage biotech company, headquartered in Newport Beach, California, is developing AIV007 in combination with its JEL™ technology – a drug the company says has the potential to address the underlying root cause of vision loss from wet AMD and treat the disease with good clinical outcomes that preserve and enhance vision in patients while reducing visits to the doctor.

How Is AiViva’s Drug Different?

AiViva’s proprietary JEL™ technology allows for the placement of the drug directly at the site of disease, where it forms a depot for prolonged drug release. A unique feature of AiViva’s JEL™ is that its delivery medium is a liquid at room temperature, which upon injection into the diseased eye tissue at a warmer body temperature quickly hardens into a gelatin-like mass. This drug-infused mass (a drug depot) then serves as a storehouse to release the drug over time to the disease site, effectively preventing blood from leaking into the macula.

In addition to stemming fluid or blood leaking, the company reports demonstrating proof of concept of AIV007’s potential to remove scarring within the macula which accounts for long-term vision loss and no current treatment addresses.  AIV007 has a unique mechanism of action by targeting multiple key receptors VEGFR, PDGFR, and FGFR, and TGFβ1.  These actions collectively and effectively address abnormal growth of leaky blood vessels, underlying inflammation and scarring. 

Other companies offering maintenance treatment for wet AMD include Ocular Therapeutix Inc. OCUL, Eyepoint Pharmaceuticals Inc. EYPT, Clearside Biomedical Inc. CLSD, Aerie Pharmaceuticals Inc. AERI and Graybug Vision Inc. GRAY.

The company says that its distinct edge over the competition is its ability of specific drug delivery which currently available treatments do not offer - its precision medicine is advantageous to achieve long local drug action and no systemic toxicity. 

The characteristics of the JEL™ Technology also allow for the customization of drug-release profiles, easy administration by physicians, optimal drug exposure in target tissues and the development of indication-specific formulations. 

Owing to these advantageous properties of the drug, AiViva plans to adapt its JEL™ Technology for new treatments in urology, ophthalmology, and oncology. AiViva has a diverse pipeline focused on wet AMD, prostate disorders, scarring, and nonmelanoma skin cancer. It believes AiViva’s JEL™, formulated with suitable active compounds, could potentially be developed for the treatment of many other diseases, including solid tumors. 

The clinical trial for AIV007 intended for the treatment of wet AMD is expected to commence in 2023. AiViva believes that as far as the treatment of retinal diseases goes, AIV007 in its JEL™ form also could potentially be developed for the treatment of diabetic macular edema, retinal vein occlusion and diabetic retinopathy. 

An Experienced Team And Patent-Backed Products

The company’s web profile highlights a leadership team of seasoned industry experts with a track record in successful drug development and commercialization, who, under the leadership of company President and CEO Diane Tang-Liu, have reportedly brought multiple successful products to the market through Food and Drug Administration (FDA) approval.

AiViva boasts a diverse product pipeline it says is expected to address a large, combined market, potentially delivering a combined multibillion-dollar revenue. 

Its delivery technology and medical uses are protected by strong intellectual property positions with 23 issued product patents and over 40 patents pending worldwide.  

The company's founders have made multiple initial public offerings (IPOs) on the New York Stock Exchange and the Nasdaq Stock Exchange and a successful reverse merger. AiViva has raised over $30 million, including $10 million raised during 2022. 

AiViva was rated as a top 20 clinical-stage biopharma company by Life Sciences Review in 2022 and could be one to watch in the transformative treatments in the ophthalmology space.

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