New Medication For Dry Macular Degeneration

Anti-VEGF therapy has revolutionized ophthalmology. Anti-VEGF drugs are effective in decreasing visual loss due to wet form age-related macular degeneration, which involves blood vessel and scar tissue growth beneath the retina.

On Friday, Eylea received FDA approval as a new formulation which can now be administered every other month instead of monthly, which will relieve both patients and practices that currently need to administer its injections regularly.

Tinlarebant

Addressing retinal diseases at their source and stopping their progression have been at the core of recent advances. At Angiogenesis, Exudation, and Degeneration 2022 virtual conference hosted by Bascom Palmer Eye Institute at Miami, researchers highlighted advances in early detection for geographic atrophy and dry age-related macular degeneration (Dry AMD), as well as treatments that target disease process itself – such as antisense oligonucleotides, photobiomodulation therapies, retinal gene therapies etc.

Quan Dong Nguyen of Stanford University School of Medicine presented one-year interim data from their two-year Phase 1b/2 trial of Tinlarebant (LBS-008) by Belite Bio for Stargardt disease and Dry AMD. This therapy aims to decrease toxin accumulation that leads to Stargardt disease as well as geographic atrophy by inhibiting RBP4. Tinlarebant works by decreasing RBP4 activity to produce less toxin production.

This study demonstrated that Tinlarebant was safe and well tolerated among patients suffering from Stargardt disease, and helped slow progression of their disease. Furthermore, for those patients for whom visual acuity (VA) data were available, an average improvement of five to ten letters could be observed – which also resulted in reduced autofluorescence.

Belite Bio has already submitted applications to commence a Phase 3 clinical trial of tinlarebant in GA (the PHOENIX study) across Taiwan, Australia, and South Korea. They anticipate enrolling at least 430 patients for this two-to-one randomization between active medication and placebo treatments.

Belite Bio’s future prospects depend on various key considerations, including its research and development efforts, development and commercialization of therapeutic candidates, regulatory decisions by regulators, as well as other risks. More information about these and other risks are discussed in its filings with the U.S. Securities and Exchange Commission; its securities have been registered with them and may only be sold legally in states or jurisdictions where registration or qualification requirements have been fulfilled first.

Macugen

Macugen is an eye medication designed to stop new blood vessels from forming in the eye, an important task since this could result in fluid gathering within it and leading to central vision damage. Macugen works by blocking a protein which triggers formation of new vessels – making it one of the first in its class of anti-angiogenic medications.

This medication should be injected every six weeks for two years. While its side effects could potentially include severe inflammation of the inner layer of the eye (endophthalmitis) and retinal detachment, it’s essential to follow your doctor’s instructions regarding its usage.

The FDA recently granted approval of Lucentis as an injection treatment for wet age-related macular degeneration (AMD). The drug works by inhibiting protein VEGF that causes abnormal blood vessel growth in retina. With regular use, Lucentis can significantly improve visual acuity for patients suffering from wet AMD.

Visudyne, another new macular degeneration drug, is an injection that targets leaky blood vessels associated with wet AMD. This combination therapy of drug and photodynamic therapy (where light shines into the eye to activate and activates drug), destroys abnormal blood vessels that leak fluid into wet AMD.

According to CSFB, Pfizer and Eyetech Pharmaceuticals are on track to file an application for their anti-neovascular disease drug in the third quarter. If approved for sale, peak sales could reach $2 billion.

This medication may be taken during pregnancy; however, its effect on breast milk remains unknown. As with any medication taken during gestation, it’s important to notify your healthcare provider if breastfeeding or planning on breastfeeding, because that could put both mother and unborn baby at risk. Furthermore, FDA has classified this medication as category B which indicates it’s unlikely to harm an unborn baby; also make sure your doctor knows if you have liver or kidney issues as this could increase side effect risks.

SYFOVRE

Retina specialists will soon be able to treat patients suffering from Geographic Atrophy (GA), an advanced form of dry age-related macular degeneration. GA causes progressive, irreversible blindness that is one of the primary causes of visual loss in the US, caused by degeneration of retinal pigment epithelial cells and choriocapillaris cells; its effects may also be worsened by factors like high shortsightedness or prior inflammatory conditions.

Pegcetacoplan, commonly marketed under its brand name Syfovre, was recently approved by the FDA as the first medication approved specifically to slow progression of GA. This medication works by blocking complement cascade inhibition – an integral component in disease pathogenesis. Two Phase 3 clinical trials conducted with this drug demonstrated 16-26% decreases in rate of GA lesion growth compared with sham injection; with its full effects showing up between months 18-24.

However, it should be noted that this medication did not improve vision. Instead, it may increase risk for neovascular AMD which can quickly lead to loss of vision in some individuals. Therefore, patients with a history of neovascular AMD should be closely monitored by their physician and individuals with active eye infections or inflammation should not receive this drug.

According to its manufacturer, this drug can be administered by a vitreoretinal specialist as a monthly intravitreal injection in their office setting. It should become widely available over the coming weeks with prices anticipated between $2,190 and $2,400 per vial; and can be obtained through specialty distributors and pharmacies nationwide.

Recent approval of this novel treatment has caused a dramatic shift in how we identify and manage GA. Retina specialists are increasingly focused on this disease state, with early recognition of signs and symptoms helping patients receive optimal care that reduces progression while increasing quality of life; furthermore, targeting interventions could potentially stop it altogether; it would prove transformative both for comprehensive ophthalmologists as well as retina specialists alike.

Retrotope

Tinlarebant, an oral treatment for dry macular degeneration that works by inhibiting production of toxins that lead to progression, has shown promise in reversing vision loss. It was granted Fast Track and Orphan Drug Designation status in the U.S. It is also currently being investigated as potential therapy for Stargardt disease type 1 (STGD1).

At approximately 85%, macular degeneration patients tend to have dry AMD. This occurs when their macula thins out and small protein deposits known as drusen form on it, causing blurry central vision. 15% have wet AMD which is more serious – caused by abnormal neovascularization under their retina forming new blood vessels which leak blood or fluid, leading to scarring on their retina as well as rapid vision loss.

Scientific research has linked uncontrolled oxidative stress with AMD development. Oxidative stress results from excessive free radical production and other metabolic processes within the body. Recent studies have demonstrated that decreasing oxidative stress reduces progression of AMD as well as protecting photoreceptors and retinal pigment epithelium health.

Retrotope’s lead candidate RT011 is an oral form of DHA designed to target underlying metabolic processes associated with eye aging. By eliminating toxic metabolites that promote lipid peroxidation without interfering with DHA’s essential function, RT011 has shown promising results in animal models of oxidative stress and AMD.

Drugs could be an integral component of treating macular degeneration; it’s essential that any vision changes be reported to an ophthalmologist promptly and nutritional supplements taken may help slow its progression. A well-balanced diet should include leafy greens and colorful vegetables and fruits; consult your ophthalmologist about potential benefits and risks before making decisions regarding nutritional supplement intake.