Good morning, everyone, and thank you for joining the H.C. Wainwright Fourth Annual Ophthalmology Conference on August 15, 2024. My name is Brooke Katsof, and I'm an H.C. Wainwright analyst on the Corporate Access Team. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. We have a total of 24 publishing senior analysts and over 650 companies covered across all sectors. Please visit hcwco.com for more information. From a logistics standpoint, please make sure to reference your virtual conference online portal that provides your individual links to your meetings and all presentations. With that said, have a productive and enjoyable day, and I'd like to welcome Dr. Riad Sherif, who is the CEO at Oculis.
Thank you so much, Brooke, and extremely happy to be here to introduce Oculis and our ongoing program. Oculis is an ophthalmology-focused biopharma company. These are our safe harbor statement. Oculis is a listed company in Nasdaq, U.S., and Iceland. Our purpose is to drive innovation to save sight and improve eye care. Oculis had an exceptional year in 2023 and is starting a great year in 2024. 2023 highlight where the readout of the stage one, phase III trial, which is called DIAMOND, where really for the first time ever, we see in a phase III product as an eye drop for retinal disease, showing results which are identical to what we get with injections.
Furthermore, in 2023, we were able also to list the company in Nasdaq and raise almost $150 million dollars with the listing and with the follow-up. 2024 is starting extremely strong as well. We had a positive phase III in OPTIMIZE in post-op ocular surgery with OCS-01 as well, and we had the result with OCS-02 in a study called RELIEF in dry eye. Also, here is the first as well, first case of a biologic with a personalized medicine. I will give more the details after. We are now expecting the result of ACUITY with the third asset, OCS-05, in an indication called acute optic neuritis, with the novel SGK2 mode of action in neuroinflammation. Our portfolio consists in three major innovations.
OCS-01, based on a technology developed by Oculis called Optireach, which enables, for the first time ever, eye drops or topical treatments to treat retinal diseases. The core indication here is diabetic macular edema, where I will spend time to share more details about the result. The second asset is OCS-02, or licaminlimab, is an antibody fragment technology which allows us to have the active part of the antibody, is a TNF inhibitor for ocular inflammation, with a focus on moderate to severe dry eye disease. This product has a true potential for precision medicine approach in dry eye, which is a disease known for heterogeneous patient population.
Having a product which allows us to go into a personalized medicine, being able to diagnose responders ahead of time and give them the treatment which will treat them, will change completely the landscape in dry eye. The third asset, OCS-05, which is a promising neuroprotective agent for neuro-ophthalmology disease. I have the pleasure today to go into more details in terms of what we are doing and what to expect. Today, I will be focusing on retina, and therefore, I will be focusing on OCS-01 and OCS-05. So if we start with OCS-01 in diabetic macular edema, what we know about diabetic macular edema? As you know, diabetic macular edema is very frequent disease. We are speaking about millions of patients. It is a complication of diabetes. We are speaking about 35+ million patients in the world.
Only invasive treatments are available. Invasive means a needle into the eye, a monthly or bimonthly needle into the eye. This leads to high burden of treatment for patients who have already a very high burden of treatment due to the diabetes and due to the complications of diabetes. Therefore, we end up in a situation which you see on the right of this slide on the screen, where less than 50% of patients who are diagnosed are today treated, which leaves us with huge opportunity to treat more patients and to treat better the patients who are treated today. Product went into four clinical trials. The four clinical trials were positive, showing consistently positive readout in the regulatory endpoint, BCVA responders, and of course, the CMT, which is always used by the medical community to monitor the disease.
I'm going now to focus on the last trial. We released the data recently, a few months ago, which is the Stage one, phase III trial. In terms of patient population, we had all comers. We ended up with two-thirds naive patient and one-third previously treated patient. The endpoints are the typical endpoint, which are regulatory endpoints, which are two, as you know. The first is BCVA, the second is responders. We are currently doing the Stage two, thanks to the great success of Stage one. But let me go into the readout of Stage one. Stage one came up extremely positive in the DIAMOND trial, with a robust, statistically significant improvement in vision, a reduction in retinal edema versus vehicle. 7.2-letter gain in BCVA versus baseline at week six already, increasing to 7.6 at week 12.
25.3% of patient gaining more than 15 letters at week six, increasing to 27% at week 12. And this with consistent and rapid, very fast reduction in retinal edema already at week two. Product was well-tolerated, with no unexpected adverse event. With this great result, we started already the stage two. So these are the result in terms of BCVA, which is the primary endpoint, and the regulatory endpoint. The product shows extremely solid result, similar or identical to what we get today with an injection. So this is for the first time ever, we have a product which is topical, which is used as an eye drop, self-administered by the patient, which delivers the same result as the result we get with an injection to the eye, with a needle into the eye. This is the first time ever.
If we go to the responders, 15-letter gain at week six already in 25% of the patient, and this increased to 27% at week 12. So very good result for vision for patient. Very fast and very solid. Now, what is happening into the retina? You see it here. The product is able, as an eye drop, to reduce the retinal thickness or the CST or the CMT, and you see it very rapid reduction at week two, and which lasts over time. So the function is improving, and the anatomy in the retina is improving as well.
So in terms of efficacy, very solid result in BCVA, identical to injections, very solid result in vision with responders, identical to injections, and very rapid and maintained reduction of the edema or the thickness of the retina, which is a biomarker for inflammation of edema in the retina, which is consistent with function improvement. In terms of adverse event, the product was well-tolerated, with no unexpected adverse event. None of the AEs reported were deemed related to the study drug, no evidence of cataract formation, IOP increase consistent with the literature, and was pretty low. I will show you in the next slide. And minimal mean IOP increase was similar. Across induction, you see here, across induction and maintenance.
Now, with this profile for a product, which is an eye drop, topical, which works as an injection, and it works, and it can be delivered immediately, self-administered by the patient, extremely well-tolerated as well, how it could be used? This is a framework of the disease. This is a disease continuum. The diagnostic start with an OCT, where we see the edema here, and then the vision from left to right start to deteriorate. In the beginning, today, the patient are not treated, and it's almost we are saying to the patient, "Wait for your vision to be more severely reduced to be treated." Tomorrow, because the benefit-risk for a topical is different from the benefit-risk for injection, tomorrow, this patient will be able to start early.
So we have a pool of patient who can benefit from this from this product as a first line. This we call them early intervention. Early intervention is so important because we know that when we do not start early, we do not regain all what we lost. In general, and what is extremely well known actually, is we cannot regain more than the half of what we lost. So it is crucial to keep the function, to keep the vision, it is crucial to start early. This is on the first line. The second line, we know in DME, at least 40% of patients will respond inadequately to the treatment. So therefore, for this patient, switching to OCS-01 or combining with OCS-01 will be an alternative for them. So therefore, two segments without challenging the status quo for injections.
Two segments are not served, not at all, and can be addressed with OCS-01. The first segment is early intervention, first line. The second segment is almost the half of patients who are treated and not responding. And OCS-01 can be an alternative to switch to OCS-01 or to combine with OCS-01. So this product has a real potential to broaden the patient pool by having more patients treated early, but also broaden the prescriber pool by giving a solution, today to the general ophthalmologist who today are making the diagnosis but not having the solution to treat. So huge potential, which actually OCS-01 can generate a market bigger than the current market. We are speaking about an addressable, diagnosed U.S. patient population of 1.3 million patients who could be addressed by OCS-01.
In fact, after the result we have, as I shared with you in Stage one, OCS-01 met all functional, clinical, and pharmacodynamic endpoint, and now OCS-01 is in the Stage two of the phase III program, which is going as planned. In terms of market, today, the DME market globally is $4 billion. OCS-01 can really create a market bigger than the current DME market, and the potential is $6 billion, and this without speaking about life cycle management for OCS-01. So very solid product, which works in 4 clinical trials, consistently delivering positive result, efficacious, safe, easy access for patient, self-administered, addressing two unaddressed segment, early intervention, and almost the half of patients who are injected today and they are not responding.
In phase III, phase III is ongoing very well and expecting a result in the end of the next year or the beginning of the year after, and then NDA. Now, let me speak about OCS-05. OCS-05 comes with a novel mechanism of action for neuro-ophthalmology indication. The product is ongoing in a clinical trial in acute optic neuritis, and the product has really potential to address neuro-ophthalmology diseases such as glaucoma, acute optic neuritis, and diabetic neuropathy. What the product does. Really, the product is able to do two things. One is to reduce apoptosis by upregulating FOXO3, and therefore reducing the neuronal death, and this neuronal death in the retina. So the product reduces the death of the neurons in the retina.
The second product of upregulate as well NDRG1, which drives oligodendrocyte differentiation, and oligodendrocyte differentiation is key for the myelin, because it keeps the myelin around the axon. So what the product does, and I will show you the data from multiple animal studies. We did seven animal studies. The product really avoids the death of the neurons, and the product keeps the axon protected with the myelin. This is what the product does. It has multiple potential applications, such as glaucoma, dry AMD, diabetic retinopathy , Acute Optic Neuritis, and neurotrophic keratitis. I will show you two slide here, where the product was tested in three animal models or three disease model: acute optic neuritis, multiple sclerosis , and glaucoma.
Consistently, when you measure the retinal ganglion cells, animals receiving OCS-05, regardless of the route of administration, are able to protect their retinal ganglion cell from dying. So the product, anatomically, when you do the biopsy in animals, you can see that concretely, animals receiving OCS-05 in stress models, due to glaucoma or acute optic neuritis, are able to protect their retinal ganglion cells from dying. The second on the right, OCS-05 shows an action to promote improvement of clinical function. And here you see that animals receiving OCS-05 are able to have a better function than animals not receiving OCS-05. So we see it anatomically, we see it in the function. This is on the retina and ganglion cell. If we go to the optic nerve and the axon, the same thing.
Animals receiving OCS-05 are able to reduce the optic nerve, nerve axonal loss and the demyelination. So what we are doing? Oculis became a new sponsor in Q3. We acquired this product in 2022. Currently, we have one completed phase one, which didn't show drug-related side effects, which was done in Europe. We have an ongoing phase II ACUITY trial, first in-patient trial in acute optic neuritis. This trial is ongoing, the randomization is finished, and we are expecting a readout in Q4. And in the U.S., we are planning to submit IND submission for OCS-05 in the US, which is anticipated in the fall 2024, around the readout period this year. So this year, two milestones for OCS-05: the IND submission in the U.S. and the readout for ACUITY trial. So rapidly, a snapshot about AON.
AON is an orphan indication, Acute Optic Neuritis. We do not have a treatment available. The product has an orphan designation in the U.S. and in Europe. What we see in this disease, we see here that the patient have a blurry, blurry vision, and this is, in many cases, the first symptom before Multiple Sclerosis. What happens? It is an inflammation of the optic nerve. It is an acute inflammation of the optic nerve with impact into the retina. And what we are the first endpoint, of course, is safety. This is first in-patient, but we have a multiple exploratory endpoint, which we are going to measure, which will give us a signal for the next steps in terms of thickness of the retina mainly. So this is the study.
Randomization is finalized, 36 patients randomized, five-day treatment. This is an injectable five-day treatment and six months evaluation period with a readout, in terms of imaging at, month six. So in summary, Oculis has been a company with a very efficient management of capital and very solid execution. As a private company, we raised $110 million as a private funding. We successfully validated Optireach with OCS-01 in DME and post-ocular surgery. We have strong and balanced portfolio with OCS-01, completing the risk in phase III, OCS-02, moving to phase III . We didn't discuss it in trial, but moving to phase III. And OCS-05, which is, an extremely, promising mode of action in applications where we do not have a solution today. So huge unmet medical need, huge potential.
We had a very efficient deployment of capital, transforming Oculis from a hospital project into a multi-asset, a company with late-stage candidates. We have been able, as a public company, to successfully do a listing in the U.S. and Iceland, where the company originated from. We raised $205 million raised in last year and this year. We are adequately capitalized to drive our programs till late 2026, and we have a track record of success with multiple near-term catalysts with OCS-01, OCS-02, and OCS-05. Thank you very much!