A Clear Vision: The Progress of Ophthalmic Disease Drug Development

Impairment or loss of vision is one of the most common sensory disabilities at a global cost of about $1 trillion. In 2015, the International Agency for the Prevention of Blindness estimated that 253 million people across the globe suffered a visual impairment due to an ophthalmic disease – and 36 million of them were functionally blind.

Advancements in technology and medical science have allowed doctors (specifically ophthalmologists) to diagnose and treat more patients. However, the majority of ophthalmic drug approvals since 2000 have simply been reformulations of previous medications while the rate of developing new biologics has fallen.

How much progress has ophthalmology made since its earliest records? And following that, what are the anticipated future trends in the diagnosis and treatment of ophthalmic disease?

Ophthalmology: A History

This particular field of science has a long history, with written records of medical treatments dating back to ancient Egypt. It is clear that while the Egyptians did not have a comprehensive understanding of the eye and how it functioned, they still recognized different conditions that affected it.

Records from 1500 B.C. outline animal and mineral-based ointments for treating bacterial eye infections. There are also details on treatments for cataracts. A major development in this field was the appointment of Baron de Wenzel as oculist to Britain’s King George III. He revolutionized the method of diagnosing and removing cataracts.

From there, knowledge steadily grew about the eye, its structure, and the conditions that affect it. One of the greatest advancements was the ophthalmoscope, invented in 1851 by German doctor Hermann von Helmholtz. It allowed doctors to examine the eye at up to 15x magnification, which led to a more in-depth understanding of the retina and other parts of ocular anatomy.

Then came the tonometer, which measures intra-ocular pressure that may be linked to glaucoma, a progressive loss of vision due to pressure on the optic nerve. In the 20th century, this breakthrough technology allowed doctors to diagnose and treat glaucomas.

In modern times, ophthalmology as a medical field continues to evolve and advance. There are now treatments for ophthalmic disease and other eye conditions, such as Laser-assisted in situ keratomileusis (LASIK), an eye surgery to correct vision in which a laser reshapes the inner cornea. Many researchers are finding ways to apply robotics to medical procedures. Technologies like the da Vinci Surgical System, for example, provide surgeons the tools to offer patients robotic-assisted surgery that’s less invasive.

Prevalence and Types of Ophthalmic Disease

Billions of people across the globe have some form of ophthalmic disease or vision impairment, with almost half of the cases either preventable or undiagnosed. According to the World Health Organization, of those 1 billion, 826 million people suffer near vision impairment from unaddressed presbyopia – a refractive error wherein the eye lens stops focusing light on the retina. Presbyopia tends to affect middle-aged and older adults.

Other leading causes of vision impairment include refractive error (88.4 million), cataracts (94 million), age-related macular degeneration (8 million), and glaucoma (7.7 million).

There are also distinct regional differences in the prevalence of distance vision impairment in low to mid-income regions versus high-income areas. For example, the rate for unaddressed near-vision impairment is over 80% in sub-Saharan Africa versus a rate of below 10% for North America and Western Europe. The same is true for countries with growing populations and a larger proportion of elderly adults.

However, the prevalence of specific conditions – meaning, the causes of vision impairment – varies per region. Cataracts are more common in low to mid-income regions versus glaucoma and age-related macular degeneration in high-income countries.

Technological Innovations in Ophthalmology

Pharmaceutical developments may have slowed somewhat, but the technological side of ophthalmology has made leaps and bounds in recent years. There have been plenty of innovations that enable better and more efficient treatments for ophthalmic disease, and eye conditions and more are coming in the future.

Artificial intelligence in ophthalmology

AI (artificial intelligence) is not just taking the creative fields by storm – it’s also made its way into the medical and healthcare industries. The use of AI can make screening for ophthalmic diseases more optimized and systematic, and allow doctors to work with more patients.

For example, primary care physicians could use AI programs to screen for diabetic retinopathy. The AI can scan a photo of the eye taken by a fundus camera, and detect whether the patient has the condition. From there, it can recommend actions for the doctor to take or provide specialists that the patient can consult.

Then there’s the detection and diagnosis of geographic atrophy, a chronic and progressive degeneration of the macula. Interpretation and measurements of an optical coherence tomography (OCT, a light-based eye ultrasound) can take a specialist almost an hour. But an AI system can do the same in seconds.

Currently, the use of AI in ophthalmology is primarily focused on enhancing disease diagnosis and aiding in decision-making for various ophthalmic conditions such as diabetic retinopathy, glaucoma, age-related macular degeneration, cataracts, and other anterior segment diseases. However, while there have been some AI systems developed for these purposes, most of them are still in the experimental stage, and only a few have been successfully applied in clinical practice. This can be attributed to several factors, including concerns around security, privacy, limited implementation, trust, and the ability to explain how the AI arrives at its conclusions.

Gene Therapy in Ophthalmology

Gene therapy is an exciting area of innovation in ophthalmology that holds great promise for treating diseases such as inherited retinal diseases and AMD. Luxturna (voretigene neparvovec-rzyl), was approved by the FDA in 2017 for the treatment of inherited retinal disease caused by mutations in the RPE65 gene. This gene therapy involves injecting a viral vector containing a healthy copy of the RPE65 gene into the retina of the affected eye, which can restore vision in some patients. This approach has shown great success in clinical trials and offers hope for patients with previously untreatable genetic eye diseases. While gene therapy is still a relatively new field, ongoing research and development hold promise for future breakthroughs in treating inherited retinal diseases and other genetic disorders affecting the eye

Bionic eye implants

Bionics is the application of biological and natural systems to engineering and technology. In medicine, this equates to the replacement or enhancement of organs and body parts with mechanical appendages. One of the best-known bionic devices is the cochlear implant, a device that provides a sense of sound to deaf persons.

In terms of ophthalmology, specialists have been developing “bionic eyes.” There have been different designs, such as the Argus II Retinal Prosthesis System. This consisted of a pair of eyeglasses with a small mounted camera that transmit signals to electrodes implanted in the retina. This potentially allows people to discern shapes, movement, and light – although it does not mimic full vision.

The Argus System experienced issues some years ago after its parent company ran into financial issues, which left patients without technical support. However, more companies and institutions are researching and testing out other electronic devices to improve impaired vision.

The University of Sydney and The University of New South Wales recently trialed its Phoenix99 bionic eye in sheep. This technology aims to help blind people see with a retina stimulator positioned in the eye and a communication module implanted behind the ear. Implantation of the bionic eye saw no unexpected reactions, which could pave the way for in-human clinical trials once the technology has been refined and improved.

Intravitreal Injection Added Pain Relief

Korean medical device company RecensMedical has recently started its pivotal clinical trials on the Ocu-Cool system, a precision medical device that delivers rapidly-cooling anesthesia for painless intravitreal injection therapy.

Intravitreal drug delivery has become the standard for treating several retinal diseases, such as uveitis, diabetic macular edema, and retinal vein occlusions. Pain is a common adverse effect of the procedure, although doctors address this with anesthesia. Current delivery methods include topical anesthetics or subconjunctival administrations.

However, these methods are not without their downsides, and in the case of subconjunctival delivery, may be more painful than the intravitreal procedure itself. RecensMedical has partnered with Vial, a contract research organization (CRO), to conduct its pivotal “COOL-3 clinical trial in order to streamline its tests ahead of US FDA review.

Home-based OCT machines

OCT is a widely-used form of ophthalmic imaging that lets doctors examine eye tissues at high resolution without invasive procedures. Both the machine itself and the imaging procedure can be costly. But now, some clinical device companies are developing home-based OCT machines to make imaging more accessible and affordable.

The technology isn’t quite there yet, given the difficulty of scaling down expensive medical devices for personal use, but the medium-term goal is to create working samples that can be submitted to the US FDA for review.  This would allow for safety measurements in patients’ homes, with the possibility of reducing the number of clinic visits during a clinical trial.

Advancements in contact lenses

The idea of delivering medication via contact lenses isn’t new, but the innovation itself is very recent. In 2022, Johnson & Johnson Vision received US FDA approval for its Acuvue Theravision with Ketotifen. These are the first drug-eluting lenses available on the US market.

The Acuvue Theravision are daily disposable contacts that prevent ocular itching due to allergic conjunctivitis. As of now, they are only wearable by patients without red eyes or astigmatism of more than 1.00 D.

Each lens carries a 19μg dose of Ketotifen, which then quickly diffuses in the first hour after putting them on. Over the ensuing hours, ocular tissues absorb the medication, which prevents ocular allergies. The duration of release and effectivity lasts about 12 hours.

Another innovation to contact lenses is Alcon’s Clareon intraocular lenses. These have the lowest level of haze and subsurface nano glistenings, leading to sharper and clearer vision that also reduces glare.

The Impact of New Treatments on Patients

Innovations like these have transformed or have the potential to transform the lives of hundreds, thousands, even millions of patients around the world. Bionic eyes could lead to more visually-impaired people regaining their sight, for example, while home-based OCTs could lead to more efficient and affordable diagnoses – and more proactive treatments.

This impact on patients is often not discussed as much as the next technological breakthrough, but the whole purpose of these treatments is to change patients’ lives. Many of these people may feel like degrading vision is stealing away experiences – that they are losing their lives through no fault of their own.

The personal impact of vision impairment can be enormous. For children, early-onset visual disabilities can delay development in motor skills, language comprehension, social and cognitive prowess, and more. Meanwhile, vision impairment severely impacts the quality of life for adults, with lower rates of workforce participation and higher rates of neurodivergence.

For Tarsier Pharma’s founder, Dr. Daphne Haim-Langford, the importance of a treatment’s impact on patients resonates strongly with her, since she has been in that position. As a child, she was diagnosed with uveitis, a chronic recurrence of eye inflammation and a leading cause of blindness. Of those with uveitis, 22% will become irreversibly blind.

Uveitic glaucoma is one of the most serious complications of intraocular inflammation. It is considered a rare condition but is recognized as a frequent cause of preventable vision loss. Uveitis affects more than 2 million people worldwide, with a significant number of these people suffering permanent damage to the retina.

Tarsier Pharma’s flagship product is a treatment for uveitic glaucoma, with the drug in Phase III of clinical trials. Treatments like those Tarsier Pharma develop are trying to give people those precious life moments back. The company is the first to conduct in-depth research on uveitic glaucoma, and there are many more following in their footsteps as well as researching other visual impairments. The hope is to prevent more cases of visual disabilities – or to find more cures.

Seeing Clearly Into the Future of Ophthalmic Disease

The future of ophthalmology is clear and bright, with more technological advancements on the horizon. It may be that eye conditions, once considered untreatable or unpreventable, will eventually see treatments and cures. The world is 3 years into a new decade, and anything is possible as CROs like Vial, IQVIA, and PPD work alongside pharmaceutical companies and ophthalmologists to carry their visions forward.

For biotech companies looking into ophthalmic drug discovery and research, CROs like Vial help deliver faster, better, and more efficient clinical trials with our innovative end-to-end technology platform. These studies are a cornerstone of clinical research in any therapeutic area, so maximizing performance and productivity benefits sponsors, CROs, and patients alike.

Vial is a tech-first CRO that empowers scientists to research and develop next-generation medical treatments. Our technology platform streamlines the procedures and processes in drug discovery to deliver faster, better, and cheaper clinical trials. In addition to Vial’s Ophthalmology CRO, Vial operates across several therapeutic areas, including dermatologyneurology, and oncology.

Partner with Vial for tech-powered solutions to your clinical trial needs. Contact us today!

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