A vision for the future: Richard Sokolov on the new standard in Ophthalmic Drug Delivery

IDE Group has built its reputation helping others develop and commercialize medical technologies and devices. What led to the decision to create and commercialize your own device?

I think it is important to understand that in our inception and practice, IDE is a development and commercialisation company. Our purpose is not only to develop a novel product but to help establish or grow a business around that product, which has a meaningful impact on the future of health. To date, this approach has brought significant value to our clients, partners and users. We have been thoroughly embedded with them in developing novel medical products, helping them navigate the complexities of innovation, regulatory approvals, and commercialisation.

This experience has given us a deep understanding of the challenges that often hinder great ideas from becoming widely adopted solutions and how to overcome them. We are always looking for opportunities to make a positive impact with our work, and taking products to market ourselves helps us maximise this impact. We have done this before with ventures such as ASX-listed Atomo Diagnostics. As the director of our newly formed IDE Medical Devices group, my focus is on finding more opportunities to do so, and this is where OKO comes into the picture.

While working on an adjacent ophthalmic project, we knew drug delivery into the eye could be improved. However, the more we looked, the clearer and more critical the deficiencies in the standard of care became. We asked why it needed to be this way. It didn’t, so we set out to see if we could make a meaningful change. This has led us to create a purpose-built ophthalmic auto-injector, which we named “OKO”.

What were the challenges you saw in ophthalmic drug delivery, that led to the development of OKO?

Intravitreal injections are very effective in treating many retinal diseases, such as wet age-related macular degeneration, diabetic retinopathy, and geographic atrophy. Existing devices used for injections are simply adapted from other applications rather than designed specifically for the unique challenges of the eye. This makes ocular injection unnecessarily complex. For example, the current gold standard is to use glass prefilled syringes to improve procedural efficiency. They are generally used for 1mL injections into your stomach or thigh, but are now used to deliver 0.05mL into the highly complex structures of the eye. This mismatch introduces significant variability in drug delivery, procedural complexity, the potential for adverse events and unnecessary inefficiencies. These compromising factors can negatively impact clinical outcomes and access to clinicians, leading to poor treatment compliance and thereby diminishing a patient’s quality of life.

This does not only impact the patient. Pharmaceutical companies require precise and consistent drug administration to ensure therapeutic effectiveness and differentiation of their treatments from increasing competition in large, growing and competitive markets. Then we have clinicians. Their primary goal is to provide great care to their patients and to treat as many as they can. With ocular injections now a large part of their workload, they face an inefficient, manual process demanding meticulous precision, assistance and high cognitive load, with the potential for dose errors and complications. In our view, highly skilled clinicians should be able to focus more on managing their patients’ care and performing more complex medical procedures, rather than be overburdened with routine injections.

With OKO, we’re tackling three critical challenges of intravitreal injections: therapeutic efficacy, procedural complexity, and treatment efficiency, all in a single device. As one of our clinical advisory board members put it recently, OKO ensures the delivery of “the right drug, at the right dose, to the right ocular compartment”.

How did IDE initially approach OKO, and what impact are you foreseeing OKO to make in the industry?

The early stages of development were shaped by extensive research, clinician engagement and testing against existing methods. This involved working with clinicians in multiple regions, including the United States, the Netherlands, and Australia. Our focus was to understand both their problems and the value of our emerging solutions.

Our early value proposition focused heavily on speed, efficiency and safety. But as we progressed, we began to understand that we had to do a lot more to make a real, meaningful impact. Most ophthalmologists believed they were efficient with their current techniques and could do them well. We had to offer a significant improvement on what they were doing now, which meant it had to be a more comprehensive offering.

Initial contact with pharmaceutical companies was positive; they could see the value in differentiating their treatments from competitors, especially if clinicians preferred the new device. However, to make it compelling, the device had to utilise existing primary packaging, fit into standard fill-finish processes, and address their core concern of their drugs clinical effectiveness. Additionally, many new ophthalmic therapies are emerging with very different characteristics impacting how they can be delivered, such as high-viscosity, high dose volumes, ultra-low dose volumes, solid implants, etc, all of which traditional syringes will struggle to handle without significant and detrimental compromises.

So, we quickly understood that for a device to be adopted as a new standard of care in a space that has seen little innovation to date, it had to address all these issues in one device seamlessly. It meant rethinking, enhancing and evolving the device to do just that.

From your perspective, what unique impact do you anticipate OKO will have in the industry?

The primary differentiator of OKO is that it’s a comprehensive injection system designed to reduce or eliminate the compromises clinicians currently face in delivering injectable treatments. With OKO, a clinician no longer has to sacrifice accuracy for speed; precision doesn’t add cost; it reduces it. Faster injections don’t compromise safety or increase the potential for errors; treating more patients doesn’t lead to lower-quality outcomes. With OKO, achieving efficiency, safety, and exceptional patient care simultaneously is possible.

For example, if we look at prefilled syringes, most injections are inaccurately dosed. Up to 34% of injections are underdosed, reducing drug response up to 10 days in a 4-week treatment period.¹ Overdosing causes high intraocular pressure (IOP) spikes, and the prefilled syringes result in IOP spikes at rates four times that of vial-drawn syringes, adding risk to patient vision.² OKO enables quick, error-free dose selection and accuracy up to 59 times better than prefilled syringes.³

Additionally, our research indicates that for a busy clinic doing many injections, labour costs account for approximately 66% of the clinic’s expenses.⁴ OKO reduces procedural steps by 45%, over the standard of care and can increase patient throughput by between 21-70%, simultaneously reducing cost by 37–78% per injection, depending on who performs the injection.³ OKO has been designed to be used without the need for an assistant.

Feedback to date on OKO has been extremely positive and encouraging, with 90% of clinicians preferring it over prefilled syringes.³ Pharmaceutical companies have also shown strong interest, and we’re now engaged in developing the device for its first therapeutic applications.

What challenges do you anticipate, and how is IDE preparing for market entry?

Currently, our approach is to advance OKO toward commercialisation through strategic partnerships. Several partners are eager to leverage OKO’s benefits, bringing enhanced treatment experiences to their customers and patients. As early adopters, they understand the competitive advantage OKO provides them in the rapidly growing ophthalmic market.

We recognise the significant challenge in shifting the current standard of care, and our program is specifically designed to address this by continually engaging key opinion leaders and conducting rigorous clinical evaluations to ensure the high desirability of our device. As is our way, we are also simultaneously addressing issues and risks associated with the feasibility and viability of the product and business. Early drug compatibility and delivery performance will be established, as will compatibility with standard manufacturing and sterilisation processes.

How do you envision OKO shaping the future of ocular injection treatments and addressing evolving needs?

We believe that the market is recognising the issues we see. For example, late last year, Bayer and Regeneron launched OcuClick^TM for the high-dose variant of its blockbuster, anti-VEGF Eylea^®. However, like some earlier assist devices such as Zeiss’s Precivia^®, it only tackles a single issue, such as dose accuracy or injection positioning, not both or any of the other issues we have just discussed for that matter. Our revolutionary device is intended to go well beyond this. In an article this February, Roche’s CEO cited their prefilled syringe as the key factor in protecting their own blockbuster Vabysmo^TM from competitors. So we believe that these signs point to good timing for OKO.

Ultimately, our goal is to enhance the standard of care for all in-clinic, non-surgical ocular injections. OKO is a versatile platform capable of delivering current and novel future therapies and forming the basis for other ocular injection modalities.

Additionally, as healthcare systems increasingly focus on reducing costs and boosting treatment capacity, delegation of injections to nurses and assistants is rising. OKO can enable a greater shift in who administers injections, without compromising patient safety or the quality of care.

A key driving factor for IDE is to make a difference in healthcare and we are fully committed to OKO being the vehicle for that in ophthalmology.