Reshaping Myopia Treatments

Myopia-nearsightedness-is a major and growing health challenge. While it's now the most common eye disease in the US, The World Health Organization (WHO) estimates that half the world's population will be affected by myopia in 2050. WHO also predicts that the severest form of myopia will grow to 10% of the population. This growth is dwarfing the surge of other eye diseases-glaucoma, cataracts, macular degeneration and diabetic retinopathy.

Ritedose is positioned to support this evolving treatment landscape through its specialized sterile manufacturing capabilities, helping ensure a reliable supply of safe, high-quality ophthalmic medications while providing manufacturing expertise that can support the clinical development and eventual commercialization of emerging therapies.

Myopia is caused by thinning and weakening of the retina and optic nerve, resulting in nearsightedness. It almost always starts in childhood and is progressive as a person with myopia ages. It's believed the increasing prevalence is due in part to increased time spent indoors, prolonged screening viewing times and reduced exposure to natural daylight, particularly among children. Common treatments include corrective lenses and certain surgical procedures. The disease's increased prevalence and potential for causing severe visual impairment calls for a need for treatments to evolve beyond these measures.

Few Therapeutic Options

There are currently no approved pharmaceutical treatments for myopia in adults, while atropine can be used to slow myopia's progression in children.

Researchers continue to collect more data on the overall safety, effectiveness and treatment dosages of the drug. Several studies have shown useful dosages among children, ranging between 0.5% and 1.0%, though one study showed that very low dosages (0.01%) had no discernable effect on the myopic eye. Dose studies are continuing, because the stronger doses can cause light sensitivity and blurry near vision while taking nightly eye drops.

Although Ritedose does not currently manufacture atropine eye drops, its established Blow-Fill-Seal (BFS) expertise provides a platform for supporting the development and production of future ophthalmic therapies. Ritedose leverages its expertise to deliver precise, aseptic manufacturing of sterile ophthalmic and respiratory medications, helping protect product integrity, maintain sterility and support consistent quality at scale.

Seeking Newer Treatments, Some From Old Studies

Meanwhile, the search for more effective myopia treatments continues beyond dosage studies. The National Eye Institute is looking at certain combination therapies of atropine and specialized eyeglasses, and the US Food and Drug Administration (FDA) formed an advisory committee to review another proprietary 0.01% atropine formulation, after the agency rejected the sponsor company's New Drug Application (NDA).

Another candidate, 7-methylxanthine (7-MX) has shown reduced experimental myopia in preclinical tests, and clinical data show slowing myopia progression in children and adolescents. The drug, an oral caffeine metabolite taken, has been studied for decades, and is used under compassionate-use protocols in Denmark. The studies show a dose-dependent association between 7-MX and reduced myopia progression, more so than seen with atropine. So far, no side effects have been reported. Researchers are also experimenting with a sustained-release version of 7-MX, which, if successful, could reduce the number of times the drug is administered.

Manufacturing with Sterility in Mind

Ritedose is a leader in the manufacture of sterile ophthalmic drugs. The company recently partnered with Tenpoint Therapeutics to manufacture Yuvezzi™ 2.75%/0.1%, the first and only dual-agent eye drop FDA approved for the treatment of presbyopia. Although presbyopia and myopia are distinct conditions, the same manufacturing principles apply. Ritedose uses BFS technology to aseptically form, fill and seal liquid medications in a single, automated, closed system.

Ritedose specializes in the gold standard of sterile packaging. All ophthalmics currently manufactured by Ritedose are in single-unit doses. This minimizes the risk of microbial contamination, since the vial is sealed at the manufacturer, and opened only once, by the patient. Once a multi-use container is opened, the risks of contamination increase.

This is extremely important, particularly with ophthalmic drugs. The immune system environment in the eye is quite different from the rest of the body. Immune cells do not react as aggressively as in other tissues, sparing the harmful effects of inflammation and white cell buildup. This means that microbial contamination can occur much more easily in the eye, underscoring the need for strict aseptic drugs.

Ritedose Can Help Reshape Myopia Care

As a contract development and manufacturing organization (CDMO), Ritedose is by no means limited to manufacturing ophthalmic drugs for myopia and other diseases. It can also assist with clinical trials of new potential ophthalmic formulations. We have a strong track record meeting increased demands for drugs on FDA shortage lists, such as albuterol, and for being a reliable provider of clinical trial drug candidates.

In October, we opened our new advanced analytics laboratory, which provides technologies and testing facilities to ensure high-quality, safe and aseptic drug products. The $17 million investment will support Ritedose, and a broad life sciences ecosystem. It boosts our capabilities to partner with companies all over the country to bring therapies to market faster and more efficiently-including potential therapeutics for Myopia.

The future of myopia treatment will be shaped by clinical innovation, but bringing those therapies (either during a trial or after an NDA) requires equally thoughtful innovation and large volume capacity in manufacturing.

Investigating a new myopia treatment? Looking for a solid manufacturing base? Come to Ritedose and let's discuss.

About The Ritedose Corporation

Ritedose is the largest sterile contract development manufacturing organization (CDMO) in the US specializing in sterile Blow Fill Seal (BFS) technology that ensures sterile, consistent, and safe unit dose delivery. The Company's process guides the development of molecules from clinical trials to commercialization of branded and generic inhalation and ophthalmic medications. With a focus on quality, innovation, and customer satisfaction, Ritedose partners with leading pharmaceutical companies to deliver safe, effective, and reliable medications that improve patient outcomes. For more information about Ritedose and its services: visit Ritedose.com.