OptX Labs

Increasing the efficacy of ocular drug delivery using dissolvable contact lenses.

The World Health Organization notes that over 1 billion people have vision impairment that could have been prevented or addressed. Treatments for diseases such as glaucoma, cataracts, and age-related macular degeneration have been discovered, but they have not significantly reduced the number of affected individuals.

These treatments have a common theme amongst them: eye drops. Studies estimate that eye drops are used for about 90% of all ophthalmic drugs. While seemingly convenient and non-invasive, eye drops are not an effective method of ocular drug-delivery. The eye can only absorb around 5% of the eye drop in typical situations, meaning that the majority of the solution is being wasted. The other 95% of the dosage is lost to tear drainage and absorption into the conjunctiva — a membrane that covers the front of the eye but isn’t part of the deep tissue that these drugs target. Patients are given higher dosages to compensate for the eye drops, which are shown to increase the severity and regularity of adverse side effects associated with these therapies. 

Eye drops must be administered regularly to combat the rapid tear turnover rate and poor absorption by deep ocular tissue. This poses another threat — the increased cost of treatment. Depending on the eye condition and the patient’s healthcare coverage, they can spend anywhere between $150 and $1000 every year. In addition, correlations are also apparent between the income of the patient and the severity of their ocular condition, especially as it relates to glaucoma, cataracts, and macular degeneration. This can be attributed both to the cost of eye drops, as well as the cost of surgery and other intense treatment options.

Moreover, the hassle and low effectiveness of eye drops can be an impediment for patients with chronic — and usually life-long — conditions, such as glaucoma. This has proved to be a leading factor in patient nonadherence/noncompliance — when the patient does not adhere to their prescribed treatment plan. The lack of immediate reinforcement can lead patients to disregard their strict dosage rates, because they aren’t able to feel the repercussions immediately afterward. Studies show that between 30 to 40 percent of glaucoma patients do not adhere to their prescribed treatment plan. This is also reflected by other studies showing that 15% to 20% of patients with glaucoma become blind even with treatment. Glaucoma affects about 80 million people, leaving 8.2 million with bilateral blindness. The nonadherence of patients leads to more severe conditions, which can also exponentially increase the cost of treatment because of surgery.

Without a more efficient method of ocular drug delivery, lower-income patients will continue to be disproportionately affected by ocular conditions. This trend has already become apparent in the United States, but can also be extrapolated to other nations as well. Glaucoma, the leading cause of irreversible blindness, can be treated in early stages to prevent severe outcomes. A more innovative approach to drug delivery will enable a more convenient and effective method of ocular treatment.

OptX Glaucoma is a nanolipid contact lens that delivers dosages of glaucoma-treating drugs. Over the period of 5 days, it slowly dissolves in the eye, leaving less residue than an eye drop because it administers small quantities at a more frequent interval. 

The lens is laden with micelles that contain Timolol and Latanoprost—common drugs used to treat glaucoma. These micelles are embedded into PLGA-based contact lens in a certain way to allow the slow dissolving of the nanoparticles over time to allow a sustained delivery for a 4-5 day period. The micelle is essentially a package that holds the drug on its interior. When that package interacts with the eye, the micelle opens and releases the drug into the eye. Due to the biomaterials used, the drugs take time to diffuse all the way from the back of the lens to the film of the eye. 

We crafted the design to include FDA approved drugs and materials to minimize the chances the product faces rejection during clinical trials. Previous studies have even shown that ocular drug delivery methods have a higher impact and success rate than conventional eye drops. Further, the safety of a contact lens is shown to comply with requirements for ocular drug delivery, creating little to no harm to the patient.  

Our solution plans to immediately serve glaucoma patients, which affects about 80 million people, leaving 8.2 million with bilateral blindness. More importantly, we see that there is a direct correlation between the income of patients and their glaucoma severity. 

We theorize that, among other factors, the cost and the inconvenience of using eye drops as a treatment option for glaucoma is why lower income individuals typically have more severe glaucoma symptoms. 89% of patients take an average of 3 drops per eye, per day to manage their disease. For the lower income patients, the sheer volume of medicine required and the persistent interval that they must administer the eye drop make it challenging to adhere to the regimen. As a result, around one-third of patients don’t follow their treatment plan. 

By making a product that only requires the patient to put on contact lenses once every 5 days and leaving no residue, we make treating glaucoma a much more manageable task. In addition, we can release precise doses in a more consistent fashion, which would drastically reduce the amount of medicine wasted because of poor absorption. This would make the product a more cost-efficient purchase, since the decreased cost of materials means that it would be cheaper than current eye drops. The effectiveness of the lenses will also decrease the amount of people with severe symptoms, decreasing the cost of treatment by reducing the need for surgery or other expensive and invasive interventions. 

As a whole, the OptX Glaucoma serves anyone with glaucoma, but is most impactful toward improving the quality of life of lower income individuals who disproportionately suffer from severe glaucoma symptoms. In the future, we hope to serve patients of other ocular conditions as well, including cataracts and pink eye. 

Akash: 

Having a background in previous research involving nanotechnology-based solutions to improve health outcomes allowed me to translate my skill set from creating nanostructures for wound healing to micelle nanolipids for glaucoma treatment. My research in nanotechnology led to a position at the Foresight Institute as a Foresight Prodigy Fellow. 

Additionally, as a team lead for the American Red Cross, I have found myself constantly in communication with those in need of help either from natural disasters or those who are in need of blood. Seeing the need for help around the world has opened my eyes and made me see the world in a more compassionate way which has funneled into the work I have done on this project. Rather than my usual purely science-based approach, I chose to shift and start looking more into the problem not just from a statistics approach but from a personal one. Hearing the stories of those affected from ocular disease like glaucoma made me realize the dire need for a better solution, especially one that addresses the reasons for patient nonadherence/noncompliance.

Ethan: 

After my grandma had her glaucoma surgery, she needed to meticulously follow her intricate eye-drop administration schedule in order to achieve a full recovery. I saw the sacrifices she had to make in order to adhere to the prescription, and wondered how other patients without a caretaker or family could maintain this level of precision. I approached Akash, and we discussed potential solutions that could improve both the quality of life of patients and effectiveness of their treatment.

With a background in product management at EV Connect and social innovation at 501CTHREE, I’ve learned how to explore the root cause of problems and find solutions that truly address the needs of the impacted. Some tools in my toolbox include user interviews and extensive research, which helped us learn of nanotechnology’s potential to disrupt the world of ocular drug delivery and the day-to-day struggles of those with glaucoma. 

These experiences have helped me understand not only the physical impact that ocular conditions can have on the patient, but also the emotional toll that they suffer. I learned of the stress that patients faced because they didn’t have enough money for their treatment and other necessities. I learned of patients’ inability to stick to their prescribed eye drop schedule due to work or other responsibilities. Because of these insights, I can create a solution that addresses the key needs of those who need it.

As a team, Akash and I have found that our working styles match well and lead to successful outcomes. In this project, Akash takes on more of a technical role, leveraging his deep background in nanotechnology to find clinical inefficiencies in current interventions and improving on them. I provide a more product-oriented perspective, always striving to connect our intervention with a pressing customer need that should be addressed. In the past, we worked together for consulting projects; we won a consulting competition for 501CTHREE and placed second in another for BenchSci. 

To understand the needs of the population we want to serve, we have taken several steps, including reading studies to understand patterns and trends in determining the population that glaucoma affects the most. 

We have learned that certain groups, such as African Americans over age 40, all people over age 60, people with a family history of glaucoma, and people who have diabetes, are at higher risk for the disease. Additionally, we have looked through papers to determine the extent to which these populations are underserved, with a focus on African Americans, who are often of lower socio-economic status and experience discrimination, resulting in lower access to proper medications and higher rates of blindness. As a result, they are a key group that we hope to serve because of the disparity of their care.

We have also identified that elderly individuals may have higher nonadherence rates due to memory loss associated with aging. We’ve read studies on the frequency of nonadherence with contact lenses, as well as witnessed the mental toll that the regimen has on elderly patients firsthand, through family members. 

Lastly, we’ve conducted user interviews with local assisted living facilities as well as elderly patients with glaucoma to understand what particular struggles they face. As a result, we’ve come to understand the day-to-day requirements of this condition, and are better able to address the convenience, cost, and effectiveness aspects of their problems.

Thus, we’ve reached the conclusion that our target demographic will typically be the elderly, but we hope to impact low-income individuals the most with our cheaper, more efficient solution.

Compared to developing solutions, we wanted to take an approach that was built on the idea of doing more. While treating glaucoma would surely make a big impact on millions of people's lives, there are millions more affected by other ocular diseases such as macular degeneration, pink eye, corneal scratches, and so on. In the future, we envision being able to take the core technology of a contact lens and simply replace the drug in the micelles to allow it to treat whatever ocular disease a patient is afflicted with.

Most ocular diseases are treated with eye drops. However, eye drops are inefficient, wasteful, and promote patient nonadherence, whereas a contact lens is simple to use and lasts much longer in a way that limits that nonadherence. A contact lens is much simpler to use and because of the way the initial design was created, the R&D costs to expand to treat other ocular diseases will be minimal. Essentially, only the interior changes (the drug) while the exterior of the particle will still be micelle-based, meaning its interaction with the contact lens matrix won't change. We envision the market shifting in this direction due to the sheer wastefulness in costs and resources that eye drops provide. Because of that, we built our solution around scalability and customizability.

We understand that each patient is different, and certain drugs that work on one patient may not work on another. Having variation in contact lenses allows us to provide for as many patients as possible to improve health outcomes for all, not just a select few.

In the next year we aim to finalize the design methodology, giving us a path to building a prototype and perfecting it through trial and error. The good news is, recently (within the last 6 months), research teams around the world have started to publish studies on this idea, showing promise for improving health outcomes. We aim to build on that momentum, identify flaws in their design, and piece everything together to create a new and improved prototype. After establishing this, we plan to partner with a pharma company to mass produce these lenses in order to get them into the market as fast as possible, considering the amount affected by glaucoma is increasing yearly. 

Looking more into long-term impact goals, we had the following in mind:

1. Treating Glaucoma

   1. According to a Fortunate Business Insights research study, the market size for Glaucoma Therapeutics was USD 6.59 billion in 2019 and is projected to reach USD 11.05 billion by 2027, exhibiting a CAGR of 6.1% during the forecast period.

   2. With the need for glaucoma treatments on the rise, we aim to capitalize on that to provide better treatments to improve outcomes as the need increase over time.

   3. Additionally we aim to significantly decrease the rates of bilateral blindness in those with glaucoma who have suffered greater medical issues due to nonaherence and adverse outcomes that come with using eye drops. (10% of ppl with glaucoma get blind, reduce that)

2. Surgeries Prevented

   1. As expressed in BrightFocus, Glaucoma surgeries include the delicate, microscopic incisional trabeculectomy (with or without ExPRESS microshunt implantation), tube shunt implantation (a shunt is a glaucoma drainage device), and cyclophotocoagulation.

   2. These surgical operations have a cost that can range from $1,000 to $2,000 while only maintaining an approximate 70% success rate, per Glaucoma.org.

   3. With OptX Glaucoma, noninvasive medical treatment is out first, enabling Glaucoma patients to be independent and proactive with their health.

3. Environmental Impact + Cost Savings

   1. As put in a Pfizer memo from 2011, “drop size is not a medical dosing issue because the human eye can only absorb 7 (microliters) of fluid.” Common drop sizes are between 25 and 56 microliters, the memo adds.

   2. Eye drops lead to tremendous waste. As NPR expresses, “eyedrops overflow our eyes because drug companies make the typical drop larger than a human eye can hold.”

   3. Moreover, Americans spend about $3.5 billion each year on eye-drop medicine, with a majority of those costs going to waste due to determined 22% — 31% eye-drop treatment compliance, per EyeWorld.

   4. A study published in 2006 in Archives of Ophthalmology reported that the annual cost of glaucoma treatment for payers ranged from an average of $623 for glaucoma suspects or patients with early-stage disease to $2,511 for patients with end-stage disease — but with a vast majority of patients (> 60%) not in full compliance with their treatment plan leading to ineffective outcomes.

   5. With OptX treatment, we can decrease all these numbers to back it environmentally sound and cost efficient to prevent any unnecessary surgeries that come with nonadherence when using eye drops

Main Materials

• Timolol maleate - drug to stop aqueous humor from forming

• Latanoprost - drug to flow out aqueous humor from eye

• mPEG-PLA - used in control release and nanoparticle formulation for drug encapsulation and delivery applications.

• Acetonitrile - solvent used to form nanoparticles with drugs

• Poly (DL-lactic-coglycolic acid) (PLGA) - Microparticles fabricated from biodegradable PLGA copolymers have been widely utilized as carriers for bioactive molecules

• Photoinitiator 1173 - used to crosslink the solution to create the matrix that holds the micelles

• Simulated Tear Fluid - used to hydrate and maintain contact lenses when not in use

Preparation of Micelle Nanoparticles

1. Timolol base creation

• Take timolol maleate salt (material) and add to sodium hydroxide

• extract solution and collect organic layers to dry

• Remaining organic solvent is removed under reduced pressure conditions to create an organic solvent

• Timolol base (main drug) is obtained

Creating the micelles (micelle - a clump of molecules in a mixture where one substance of tiny dispersed non-dissolvable particles are suspended throughout another substance)

• Micelles facilitate the movement of the drugs for glaucoma

• Timolol, latanoprost, and mPEG-PLA dissolved in acetonitrile (10:0.1 ratio of timolol to latanoprost)

• Thin layer of uniform film forms under vacuum rotary evaporation (reduces the volume of solution by distributing it as a thin film at high temp and low pressure. Promotes rapid removal of excess solvent) of the above solution

• That uniform thin film is hydrated in deionized water with moderate rotation and then filtered to remove large particles

• Resultant is timolol/latanoprost micelle nanoparticles

Preparation of micelle nanoparticle loaded contact lenses

PLGA has been demonstrated to be both biocompatible and biodegradable, and is approved by the FDA for specific human clinical applications. The advantage of polymeric based scaffold systems is the variability in drug delivery rates achieved by altering fundamental synthesis parameters. Degradation rates can be altered to be from days to years simply by varying the molecular weight of the polymeric chains, ratio of lactic to glycolic acid, or the structure and size of the micro particles. In our case we altered the weight of the polymeric chains and the final PLGA lens is predicted to dissolve in 4-5 days depending on usage on the eye.

1. Making the PLGA backbone w/ micelle nanoparticles

• Polymer (choose low weight version) dissolved in methylene chloride

• Chosen amount (based on desired concentration) of micelles added to solution containing the polymer

• Ice cold polyvinyl alcohol added to solution to double-emulsify the solution

• Solution purged with nitrogen to stabilize

Forming full contact lens

• Photoinitiator added to above solution and poured into mold of contact lens

• Mold placed under UV illumination forming thin contact lenses

Drug Delivery Method

The target time for sustained drug delivery is over a 4-5 day period to maximize efficiency due to the capacity of micelles embedded in the contact lens matrix. The main method of delivery studied is the drugs diffuse the micelles, reach the matrix of the contact lens hydrogel and then diffuse through the matrix to reach directly on top of the eye, past the tear film.

Studies show that our delivery method has a higher impact and success rate over conventional eye drops pointing to signs of improvement. Over a long period of time, our solution reduced IOP at a greater percentage than compared to eye drops. Further, safety of the contact lens is shown to comply with requirements for ocular drug delivery creating little to no harm to the patient.

As a team, our biggest obstacle is the barrier to entry of the pharmaceutical industry. We believe that, with the resources of a pharmaceutical lab, we could feasibly create the glaucoma-treating contact lens in a mass-producible way.

Nonetheless, we aim to proceed with small-batch trials when given sufficient funding. Our plan is to show the cost-effective production method of our solution and demonstrate the need for these companies to innovate on their ocular drug options. As such, we would be able to access the significant technical and financial resources of a large biotechnology firm, thus helping us create more of these contact lenses for distribution.

We are also well-aware of our current team’s lack of technical depth in applied nanotechnology. Our prototype is the culmination of extensive research and application, but we anticipate practical obstacles to arise in the manufacturing process. Nonetheless, we hope to proceed under the guidance and funding of experts, which would prime us to effectively our technical inexperience.

Lastly, regulatory affairs can be a barrier toward entry — especially since we are in the United States. The Food and Drug Administration (FDA) would have to approve our clinical trials for us to proceed to retail. Nonetheless, we have seen their willingness to approve soft contact lens therapies, such as MiSight in 2019.

At the core of OptX Labs’ business model is our desire to improve patient outcomes as it relates to ocular conditions. We target patients that require eye drops for glaucoma, and eventually hope to expand to other conditions as well. These patients will be the basis of our customer base, since they seek a more convenient and cost-effective method of treatment. In addition, their purchases will help us subsidize the distribution of these contact lenses to low-income patients, especially in countries without government-subsidized healthcare. We will seek funding from grants, as well as from the social impact arms of large pharmaceutical companies. 

The main value proposition of OptX Labs is our ability to create a more effective and cheaper solution for patients needing ocular treatments. Since we’re able to better treat patients, our solution helps both the insurance providers and the patients themselves. They are the bulk of our customer base. With this customer base, we will provide these contact lenses to the underserved patients, which will hopefully lessen the average severity of ocular diseases (especially glaucoma) around the world.

Of course, we are not a distribution-focused venture. We anticipate building relationships with impactful distribution organizations, which will help us identify and effectively distribute our contact lenses to people in need. Our other major partner will be large pharmaceutical companies, who we hope will help with the mass production and regulatory affairs of this product. 

The development of the nanolipid contact lens that treats glaucoma is the first priority. Once we are able to mass-produce this product, we will start researching other drug therapies to deliver using a micelle-based lens. Our key activities are mostly research and development, but this could evolve into more quality assurance and regulatory affairs once we have a more complete prototype. 

While a contact lens of this exact purpose does not currently exist, research papers showing the potential of a glaucoma-treating contact lens have been recently published. In addition, the FDA has approved similar soft contact-lenses for myopia prevention. Thus, we anticipate most of our competition to be incumbent treatments (eye drops), with a subset being other companies that have discovered the potential for drug delivery through contact lenses.

As a whole, we project the research and development of a prototype to range between $100-200 thousand. Once the product has been perfected, we will seek FDA approval. Upon launch, we will funnel the majority of our profit into the research and development of contact lenses treating other conditions, as well as funding the distribution of our contact lenses in underprivileged areas.

OptX will operate under both a fee-for-service and low-income client revenue models. We plan to subsidize our nanolipid contact lenses with the sales from the fee-for-service model, which will help us impact more people who otherwise could not afford our product.

For the research and development process of our product, we anticipate needing between $100-200 thousand dollars. This would cover the cost of lab equipment and materials, allowing us to make a minimum viable product to proceed to clinical trials. 

Once we have a mass-producible product, we will partner with the social impact and global health arms of major pharmaceutical companies (e.g. Pfizer, Allergan, J&J) to go through the regulatory affairs process and launch the product.

When the OptX Glaucoma lenses are available for purchase, our plan is to market heavily to insurance companies. Since we have better long-term outcomes and a cheaper cost, we believe that we can build a strong customer base through this approach. With the profits from conventional sales, we will fund our efforts in countries abroad without adequate healthcare coverage.