Methods of Using and Compositions Comprising Selective Cytokine Inhibitory Drugs for Treatment and Management of Macular Degeneration

Abstract

Methods of treating, preventing and / or managing macular degeneration are disclosed. Specific embodiments encompass the administration of a selective cytokine inhibitory drug, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with a second active agent and / or surgery. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

Description

1. FIELD OF THE INVENTION [0001] This invention relates to methods of treating, preventing and managing macular degeneration (MD) and related syndromes, which comprise the administration of selective cytokine inhibitory drugs alone or in combination with known therapeutics. The invention also relates to pharmaceutical compositions and dosing regimens. In particular, the invention encompasses the use of selective cytokine inhibitory drugs in conjunction with surgical intervention, and / or other standard therapies for macular degeneration. 2. BACKGROUND OF THE INVENTION [0002] 2.1 Pathobiology of Macular Degeneration [0003] Macular degeneration (MD) is an eye disease that destroys central vision by damaging the macula. The macula is part of the retina, a thin layer of nerve cells that lines most of the inside of the eyeball. The nerve cells in the retina detect light and send to the brain signals about what the eye sees. The macula is near the center of the retina at the back of the ey...

AI Technical Summary

Benefits of technology

[0022] The invention further encompasses pharmaceutical compositions, single unit dosage forms, and kits suitable for use in treating, preventing and / or managing MD, which comprise a selective cytokine inhibitory drug, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof.

Problems solved by technology

However, patients with the wet form can lose up to ninety percent of their vision.

These new vessels are very fragile and break easily, causing blood and fluid to pool within the layers of the retina.

As the vessels leak, they disturb the delicate retinal tissue, causing the vision to deteriorate.

It has been hypothesized that decreased water permeability impairs an exchange of nutrients, traps water and enhances the development of soft drusen and PED and eventually leads to atrophy of RPE cells.

However, the current overall understanding of ARM and MD pathogenesis is incomplete.

Because MD is most prevalent in the elderly, the fastest growing segment of the population, MD is destined to become a major problem economically and socially.

Currently, there is no known cure.

Until recently, laser photocoagulation was the only treatment routinely used for MD, and it provides only modest results.

Laser photocoagulation does not cure wet MD, rather it sometimes slow down or prevent further loss of central vision.

Without treatment, however, vision loss from wet MD may progress until a person has no remaining central vision.

The most serious drawback to laser surgery is that the laser damages some of the nerve cells in the macula that react to light, causing some vision loss.

In some patients, however, laser surgery initially worsens vision, but prevents more severe loss of vision over time.

Activated verteporfin generates highly reactive, short-lived singlet oxygen and reactive oxygen radicals, resulting in local damage to neovascular endothelium.

This causes vessel occlusion.

Therefore, verteporfin administration might collaterally damage retinal structures, including the retinal pigmented epithelium and outer nuclear layer of the retina.

However, a first clinical trial with an antiangiogenic agent, interferon-α, showed that it was ineffective at treating MD and resulted in a high rate of adverse effects.

Intravitreal injection of triamcinolone reportedly inhibits the growth of laser-induced CNVM in monkeys, but fails to prevent severe visual loss over a one-year period in patients with MD in a randomized trial.

Although new and promising strategies for the treatment of MD and related macular degenerative diseases are being investigated, there is still no effective treatment available.

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