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spk02: Greetings.
spk06: Welcome to Inovia's fourth quarter and full year 2020 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host, Eric Whitmer. You may begin.
spk01: Good afternoon, everyone, and welcome to Inovia's fourth quarter 2020 earnings conference call and audio webcast. With me today are Inovia's chief executive officer and chief medical officer, Dr. Sean Yanchule, and Inovia's chief financial officer, John Gandolfo, and Inovia's chief operating officer, Michael Rowe. Earlier this afternoon, INOVIA issued a press release announcing financial results for the three and 12 months ended December 31st, 2020. We encourage everyone to read today's press release as well as INOVIA's annual report on Form 10-K for the year ending December 31st, 2020, which will be filed with the SEC within the next few days. The company's press release and annual report also will be available on Inovia's website at inovia.com. In addition, this conference call is being webcast through the company's website and will be archived for future reference. Please note that on today's call, we will be discussing investigational products which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Inovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risk and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks, including risks related to fluctuations in our financial results, volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic, our need to raise additional money to fund our operations for at least the next 12 months as a going concern, our estimates regarding the potential market opportunity for our product candidates and platform technology and potential revenue from licensing transactions, reliance on third parties, the ability of us and our partners to timely develop, implement, and maintain manufacturing, commercialization, and marketing capabilities and strategies for our product candidates, risks of our and our licensees' clinical trials, including but not limited to the cost, design, initiation, and enrollment, which could be adversely impacted by COVID-19 and resulting social distancing, timing, progress, and results of such trial trials. the potential impact of COVID-19 on our supply chain, the timing, and our licensee's ability to submit applications for, obtain, and maintain regulatory approval for our product candidates, the potential advantages of our product candidates and platform technology, the rate and degree of market acceptance and clinical utility of our product candidate and platform technology, our ability to attract and retain key personnel intellectual property risk, and other risks related in and qualified by the cautionary statements contained in INOVIA's press release and SEC filings, including its most recent annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 25, 2021. INOVIA undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law. With all that said, I'd like to turn the call over to Dr. Sean Ayenshulet.
spk05: Thank you, Eric, and welcome, everyone, to our fourth quarter and full year 2020 earnings conference call. During the fourth quarter and more recently, we made significant progress towards advancing our proprietary clinical programs, and becoming a recognized leader in the field of ophthalmology. Most notably, we recently announced that the FDA accepted our new drug application for MidCombi, our proprietary fixed combination midriatic, for potential use in the over 80 million comprehensive eye exams currently conducted each year in the United States. If approved, Not only would MidCombi be the first microdose ocular therapeutic applied with our proprietary high-precision smart delivery system, the OptiJet, but it would transition us into a commercial-stage company. We have been given an expected PDUFA date of October 28, 2021, for MidCombi, and if approved, we believe we can effectively and efficiently market MidCombi with a small and highly targeted field sales force in combination with a specialty pharmacy network. Michael will elaborate on this shortly. We also announced earlier this year that the first patient had been involved in our Vision 1 Phase 3 clinical study, evaluating our proprietary pilocarpine formulation, Microline, which is also delivered via the OptiJet for the improvement of near vision in patients with presbyopia. I'm happy to announce that vision one is now fully enrolled and we're on track to deliver top line results in the second quarter of 2021. As a reminder, presbyopia is the age-related hardening of the eyes lens causing blurred near vision. Vision impairment typically begins after the age of 40 and is often corrected with eyeglasses or readers, contact lenses or surgery. We believe MicroLine has a significant market opportunity in that it's estimated that presbyopia affects more than 113 million people in the U.S. alone. Recall that our third clinical program, Micropin, for the reduction of pediatric myopia progression has been outlicensed to Bausch Health in the U.S. and Canada. In addition, we have outlines of Micropin as well as Microlign to Arctic Vision in Greater China and South Korea. To date, these partnerships have generated a total of approximately $16 million of upfront and milestone-based non-dilutive license fees with the potential to increase to approximately $100 million in gross non-dilutive capital once potential non-sales-related milestones as well as clinical cost savings or reimbursements are taken into account. With one NDA accepted, a second Phase III program now initiated and fully enrolled as well as several robust development partnerships with ophthalmologic leaders established, I'm very pleased with our progress last year and believe we have entered 2021 with significant momentum and line of sight to multiple potentially value-creating milestones. At this point, I would like to hand the call over to Michael to provide some highlights from our NITCOM-B program. Michael? Thanks, Sean.
spk03: As Sean indicated, we recently announced that the FDA has accepted our NDA for MidCombi, our proprietary midriatic agent administered via our microdose array print or MAP technology, upon which our OptiJet dispenser is based. The current standard of care for pupil dilation requires multiple eye drops given at least several minutes apart. This can take considerable time and often cause both discomfort and drug overflow. Prior research has found that as many as 90% of eye care providers reported that they encounter situations where patients skip the comprehensive eye exam because they do not want to undergo an uncomfortable pharmaceutical pupil dilation procedure. So we believe there is significant need for an improved process of pupil dilation to help make sure that everyone who should have a comprehensive exam is more willing to get one. Additionally, in the age of COVID-19, there is greater sensitivity to the usual practice of sharing conventional droppers of pupil dilation medication across a number of patients. MidCombi was developed with the goal of providing a touchless fixed combination microdose formulation designed to improve the hygiene related to the process of pupil dilation and improve the efficiency of the process. The OptiJet is designed with no protruding parts. which may help prevent accidental touching of the ocular surface to help reduce the chance of cross-contamination between patients. The Midconvy NDA submission was based on the Phase III MIST I and MIST II studies. In these two studies, a fixed combination of microdose tropicamide 1% and phenylephrine 2.5% ophthalmic solution met the study's primary endpoints and was shown to be safe and effective for pharmacologic medriasis. Approximately 94% of treated eyes achieved 6 millimeters or greater dilation at 35 minutes post-installation. Adverse events were infrequent, with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia, or installation sight pain. The study results were recently published in the peer-reviewed journal, Therapeutic Delivery, and are available online in an open-access format. We have received an expected Bidufa date of October 28th, 2021 for MidCombie and have become measured investments in our U.S. commercial infrastructure. We are designing our commercial launch of MidCombie to be highly efficient if and when we receive that approval. I would like to take a moment here and explain what we mean by an efficient commercial launch of MidCombie. MidCombie is a diagnostic pharmaceutical used in eye exams. The product is not prescribed to individual patients. nor is it dependent on formulary acceptance or reimbursement. It is typically purchased by the practice on behalf of all doctors in that practice, and through our recently announced agreement with Eversata, would be distributed through a streamlined system, making use of e-commerce and real-time sales data. If our commercial launch is successful, it would eliminate the need for a large conventional sales force and detailing, which can in some cases require about 100 salespeople, and significant related infrastructure. We expect our launch, on the other hand, to be led by approximately 10 account managers who will focus on the largest practices in the largest population centers in the U.S. and expand further once those practices have incorporated MidCombi into their process. With our planned commercial launch, we estimate that we can get to approximately 50% of the patient volume in the U.S. by the end of 2022. We plan to have our Salesforce launch day ready so we can work on capturing our addressable market as quickly and efficiently as possible. We also are exploring partnerships with organizations that already have significant reach and presence into these offices to augment the work that our own account managers will be doing. It is worth highlighting that we believe the value proposition of MidCombie to the ophthalmologist or optometrist is very compelling. At a comparable cost to what they are spending today, with the use of MidCombie, Doctors can prepare a patient for a comprehensive eye exam faster than conventional midriatic drops, potentially resulting in reduced patient chair time and greater office throughput. This could, in turn, improve the practice's bottom line. We believe Mencombe's value proposition, coupled with our targeted distribution strategy, will help drive the success of our commercial rollout. Needless to say, we are excited about the potential of Mencombe to disrupt what we estimate to be approximately $250 million market. And we look forward to meeting with the FDA later this year. If approved, BitCombi would be our first commercially available product and a significant milestone for our company. With that, I'd like to turn it back over to Sean.
spk05: Thank you, Michael. As I did last quarter, I would like to take a step back for those who may be new to our story. OptiJet is our proprietary microdosing technology designed for optimal drug delivery to the eye. It utilizes microdose array print technology, similar to an inkjet printer, and horizontal delivery to administer a physiologically compatible dose to the cornea of the eye. Studies show that conventional eye drops can overdose the eye by as much as fourfold, leading to unwanted side effects and unnecessary exposure to excess drug preservatives that can be harmful. The OptiJet has been shown to achieve comparable efficacy to standard eye drop doses with approximately 75% less medication. We believe both patients and clinicians are comfortable using the OptiJet. Prior studies have found that approximately 95% of clinicians and 88% of patients were able to successfully administer medication using OptiJet on the first attempt. This compares very favorably to eyedroppers, where multiple published studies have shown that fewer than half of users are able to administer medication successfully on the first attempt. Before turning the call to John to review the financials, I would like to conclude with a review of our Phase III microline program for the improvement in near vision in people with presbyopia. Presbyopia, which is the non-preventable H-related hardening of the ocular lens, causing gradual loss of the eye's ability to focus on nearby objects, affects an estimated 113 million people in the US and hundreds of millions more in China, where we have already licensed the product to Arctic Vision. We recently announced the initiation of the Vision 1 study and anticipate data sometime in Q2 of 2021. We plan to follow this up with the initiation of Vision 2, potentially by the end of the year, subject to COVID-19 and other factors, in which we intend to test a higher dose of pilocarpine to further assess the tolerability and determine if there is a dose-dependent response. There is growing interest in drug treatment for presbyopia. Currently, the only option for dealing with presbyopia are eyeglasses, contact lenses, or surgery. Our own market research showed high interest among our target market for a drug treatment that could provide on-demand improvement in near vision. Microliner would be a companion product to eyeglasses for those times when patients would prefer not to wear eyeglasses. The market potential for an on-demand improvement in near vision may be significant. In the US alone, we estimate this opportunity to be in excess of $7 billion. Pylocarpine is a compound whose efficacy in improving near vision has been well documented. What sets us apart from the competition, in my opinion, is the OptiJet. If MicroLine is approved, we believe our technology will facilitate accurate and targeted dispensing of tylocarpin without overdosing the eye, as is common with conventional eyedroppers, a century-old technology used to administer other companies' therapies. We believe the increased portability, comfort, and safety offered by the OptiJet are among our important differentiators as we advance our development program. This is a very exciting program for us, and we're pleased to have initiated enrollment in Vision 1. I'd now like to turn the call over to John to review our financials. John?
spk02: Thank you, Sean. Now I would like to review our financial results for the three and 12 months ended December 31st, 2020. For the fourth quarter of 2020, we reported a net loss of approximately $4.2 million, or 17 cents per share. And this compares to a net loss of approximately $5.2 million, or 31 cents per share for the fourth quarter of 2019. For the full year 2020, net loss was approximately $19.8 million, or a loss of 94 cents per share. And this compares to a net loss of approximately $21.2 million, or $1.47 per share for the full year 2019. Revenue for the fourth quarter and full year of 2020 was $2 million. This revenue represents a milestone payment related to our exclusive collaboration and license agreement with Arctic Vision, which was announced in August 2020. We did not recognize any revenue in either the fourth quarter or full year of 2019. Research and development expenses totaled approximately $3.4 million for the fourth quarter of 2020, roughly flat with approximately $3.3 million for the same period in 2019. For the full year 2020, R&D expenses decreased 6% to approximately $13.3 million, and this compares to $14.1 million for the full year 2019. For the fourth quarter of 2020, G&A expenses were approximately $2.1 million compared with approximately $2 million for the fourth quarter of 2019, an increase of approximately 5%. For the full year 2020, general and administrative expenses increased 7% to $7.7 million versus approximately $7.2 million for the full year 2019. Total operating expenses for the fourth quarter of 2020 were approximately $5.4 million, and this compares to total operating expenses of $5.3 million for the same period of 2019. This represents an increase of 2%. Fourth quarter 2020 operating expenses included approximately $656,000 of non-cash stock compensation expense. For the full year 2020, total operating expenses decreased 1% for approximately $21 million compared to $21.3 million for the full year 2019. 2020 operating expenses included approximately $2.5 million of non-cash stock compensation expense. As of December 31st, 2020, the company's cash balance was approximately $28.4 million. We believe this cash balance and cash received in the first quarter of 2021 from the milestone payment, as well as warrant exercises, is sufficient to last us into the middle of the first quarter of 2022, and will enable us to bring out mid-company majority of products through the NDA process and commercial launch. In addition to completing the Presbyopia clinical program for MicroLine, and preparing our pilot manufacturing capabilities for advanced technology. This concludes our financial statement remarks. So I'd like to turn the call back over to Sean. Sean?
spk05: Thank you, John.
spk02: Thank you.
spk05: In closing, we're very pleased with our performance during the fourth quarter and full year of 2020 and subsequent period. To summarize our key highlights today, we anticipate on October 28, 2021, to do for date for our mid-combie NDA, which EVA approved gives us our first commercial product. We're rapidly advancing our Phase III presbyopia program in an estimated multi-billion dollar indication and anticipate data from our first of two Phase III studies in the very near term. And our licensing agreements with Arctic Vision and Bausch Health are progressing well and continue to offer the potential for meaningful development and regulatory outcomes, non-dilutive funding that, if realized, we plan to use to, among other things, expand and advance our pipeline of novel therapeutics. leveraging our map technology. We believe we're well positioned to achieve multiple commercial, regulatory, and development catalysts in 2021 aimed at creating long-term value to our shareholders. That concludes our prepared remarks. We would now like to open the call for any questions. Operator.
spk06: At this time, we will be conducting a question and answer session. If you would like to ask a question, Please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question is from Tim Chang with Northland Securities. Please proceed with your question.
spk04: Hi, thanks. Sean, with the Vision 1 study, in addition to the primary endpoint, you know, are there any secondary outcome measures that you're measuring here in this study? And will you be able to present any of that data in the second quarter as well when this study completes?
spk05: Yes. So I think it was a little faint to hear. I'll get to your question just to repeat it for everybody. I hope everybody can hear it. whether we have any additional endpoints in addition to the primary endpoints and whether we're collecting other data. And yes, the answer is we are collecting a lot of data. We have secondary endpoints and exploratory endpoints as well. This trial will provide a wealth of data for us. Again, as you know, this is a phase three, phase two, three study with two doses. And we are really anticipating the data to see how that does with the OptiJet. We will be able to be quite informed from this Vision 1 study before we proceed with the Vision 2 study later in the year. So yeah, the answer is yes. And now to your question about when we'll present the data, we will just have to see how that passes with our publication strategy. Of course, this probably will be done in synchronization with our registration efforts and probably not ahead of that.
spk04: I see. And maybe just one follow-up on the Mid-Combie PDUFA data. I think you guys announced that today, it's October 28th. You know, at what point do you think you will need to bring in the specialized salespeople Would it probably be more likely in the third quarter or would it be before that?
spk05: Yeah, so I will let Michael articulate it, but I think one of the parts of his presentation today was really to educate folks on really how we plan to launch this. This is not a launch where we're going to go all out blasting with 80 reps, partially because this is not your – traditional commercial therapeutic where it's prescribed one by one from one doctor to one patient. But we have some really mass purchasing distribution advantages here. And this would allow us to do it not with a conventional sales force and really do it in a very cost effective way. Most people probably think about a commercialization in ophthalmology typical to other companies. where you would have to really bring in a big cost overhead. We are not looking at that. This may happen down when we go down towards micro line a few years later where this would be justified. But a mid-combi is a really perfect way to introduce the technology, prime the market, and at the same time do it in a very cost-efficient way. So maybe, Michael, you can answer that in more detail.
spk03: Well, the only thing I would add for Tim is that we don't anticipate bringing anybody on board before August. And they would be here, you know, August, September, start to be here August, September in preparation for the approval the end of October. And we would be using that time to work with them and our medical affairs people to educate potential customers on the technology so that when we do get the approval, it becomes that much faster for us to get the uptake.
spk04: Okay, great. Well, I look forward to seeing the data in the second quarter on MicroLine, and thanks very much.
spk05: Thanks. Certainly.
spk06: Thank you. And our next question is from Matt Kaplan with Lattenberg. Please proceed with your question.
spk08: Hey, guys. Thanks for taking the question. And congrats on the recent progress. I guess starting off, maybe a question for Michael. As you're kind of nearing the PDUFA date at the end of October, can you give us a little bit more sense in terms of your recent agreement with Eversana and how that fits into your marketing plans and commercial plan strategy for MidCombi as you prepare for launch?
spk03: Yeah, and thank you very much for the questions. You know, what we're doing is all under the philosophy is we want to be as efficient as possible and not build up an infrastructure that, you know, that we're not going to, you know, have to feed. So the idea with Everson is that they can take over things like invoicing and billing and customer service and shipping and basically save us from having to have those things in-house. So basically what we will keep in-house is are the key account people because we believe they need to have specialized knowledge about the technology, which a general sales force would not have, and they can do a better job of that. But everything else, once that product is ordered and it will be all online, use credit cards, again, to keep it as simple as possible, that will go through Eversana. So basically outsourcing that entire section of what we would normally or what a company normally would have in-house We won't have to build that ourselves. Okay.
spk08: And do you see your sales force initially having kind of a very hands-on approach in terms of teaching the doctors and offices to use the device and approach it that way? Or what's your strategy there?
spk03: So the strategy is it would be hands-on. It doesn't take a lot to educate them on how to use the product. It takes about 15 minutes. But we do believe you need to be able to touch and feel it. to really get the best experience with the product. So the idea would be that our key account people would go into the practices and work with the technicians, who most often they are the ones who actually do the pupil dilation, and the office managers, they are the ones that do the ordering, and the doctors in the end do have the final say. But they would go in there, they'd spend a lunch time showing them how the dispenser works and what the advantages are and how to use it, and then they'd likely leave one for evaluation for three or four days so they can actually use it on 75 patients, and then come back and hopefully, because we'll be delighted by then, complete the sale. Great. Thanks.
spk08: And then maybe a question for Sean. Anticipating the potential success for MicroLine and Vision 1, given Pylocarpine's success in this indication already, What are your plans for Vision 2, the Vision 2 study, and how that should take shape in terms of maybe timing and then any differences you're foreseeing versus Vision 1?
spk05: Yeah, Matt, this is a very good question. And maybe in terms of background, if you remember initially, even before COVID, we were planning to do Vision 1 and Vision 2 at the same time. I think COVID... This intermediated that plan a little bit and also when we looked at it, it actually made sense to learn from vision one Maximum we can and then apply it to vision two because again, this is a really new indication There's a whole lot of companies rushing into that. We know there were two positive phase three studies from our gun abzi in with the same compound and but we haven't even seen data yet. So I think we wanted to take a more measured approach where we really learn stepwise. The plan here is really to get quickly comfortable with the Vision 1 data in Q2 of next year, Q3, and very quickly by the end of the year enroll or start initiating enrollment of the Vision 2 study. And again, Vision 2 will not be materially different from Vision 1. We're still looking for the indication for on-demand improvement of near visual acuity. So a lot of the endpoints will be the same. We may down select the dose from Vision 1, depending on the results. So I think it will be hard to say exactly what we will do, except that it's going to be very, very similar. We hope that this will be a positive study and would allow us to launch Vision 2 promptly by the end of the year. And if that happens, Matt, I think we will be able to execute very similar to Vision One. I mean, Ginger and her team did a phenomenal job in the midst of a COVID pandemic, site closure, and everything else. We were able to launch a study, operationalize it, execute and fully enroll it as we disclose today. So I think that we're going to be looking, hopefully, for a very similar cadence, a very prompt enrollment. We have so many patients. I mean, that's the beauty about this indication. There are just so many patients available. It's such a big opportunity in patient population. And patients and sites are ecstatic about not just being able to be free of hardware and change the treatment paradigm for presbyopia, they're really ecstatic about the new technology where you don't have to have overdosing to the eye, redness, and really use a very antiquated paradigm with the eyedropper to use something very modern and smart. So I think for us, we don't foresee any issues when we decide and push the button to launch Vision 2, hopefully by the end of this year. to really get very quick results for Vision 2 as well.
spk07: Great. Thank you. And, no, definitely impressive execution by your clinical team given the backdrop of the pandemic. So, congrats on that.
spk06: Thank you, Matt. Our next question is from Jonathan Ashcroft with Roth Capital Partners. Please proceed with your question.
spk05: Thank you. I was wondering, even though you were talking about mid-combine, you know, not being sold to individual patients, is there any way that it could somehow still be used off-label in amblyopia? You know, do you expect any use in that setting? Right. So, when you say mid-combine used for amblyopia, first, we as a company will never really encourage off-label use in any way. Second, I think that therapeutically today, the way amblyopia is treated is by use of atropine, not by use of a fixed combination phenylephrine or tropicamide. So again, we don't really know. I think that the response to mid-combine and to the technologies is huge. People really don't understand how game-changing that is for the eye exam today, which hasn't changed in almost 100 years, and transitioning from two or three drops to a single prey that really can alleviate a lot of the discomfort and problems that patients experience with that. I'm not I'm sure doctors and people clinicians out there who are very creative may find different applications and and certainly I know via will support them in that as a through a registration pathway if such is part of the lifecycle expansion we find but for now we're really focused on on the market and and when Michael says it's a 250 million dollar market it's a 250 million dollar market assuming that We're really on parity, price parity with the conventional paradigm, and we're not dramatically moving the price target, which may be very different once we have a very successful product and we find out that that market can be re-energized in a major way. And after all, you have so many dilations happening every year here. But who knows what the clinicians will suggest, and we'll certainly be listening to the marketplace out there. Actually, how clear have you been with what your pricing, your initial pricing will be for MidCombi? Yes, Michael, do you want to address that?
spk03: Yes, and thanks, Jonathan. We know that what doctors are spending or offices are spending now for the two drugs that they currently use is somewhere around $1, $1.50 per patient. And we've said that we're going to be very close to that. We are anticipating a price of about $100 a cartridge, and a cartridge should treat at least 75 patients. So from an out-of-pocket expense for the practice, it should not be an issue.
spk08: Okay. Thank you very much, guys.
spk03: You're welcome.
spk06: And as a reminder, if anyone has any questions, you may press star 1 on your telephone keypad. Doing so will ensure that you join the question queue. Our next question is from Len Yaffe with StockDocPartners. Please proceed with your question.
spk09: Thank you very much. And I think this is the first conference call that you've had since the promotion of Mr. Rowe to COO, so I just wanted to commend you on that new responsibility for him. My question is, when we get the results from Vision 1, will we be getting results similar to the Allergan endpoint of improvement in near vision in low-light conditions without a loss of distance vision, or will it just be a subset of that?
spk05: Yeah, Len, thank you. And again, it's a really timely congratulations, and we're very excited about the increased responsibility and role for Michael. And in that spirit, I'll just let him answer that question.
spk03: Thank you, doctor and doctor. The results that we're going to have available in the second quarter will be top line. They'll be very similar to the results that have been presented by Allergan, we're also going to take a special look, Glenn, at the side effect profile. You know, we have a strong history in clinical studies of demonstrating that by using our technology, you can get similar effectiveness and much better tolerability. And we're hoping and looking forward to being able to see that in the presbyopia trials. You know, one of the things that's held back pilocarpine as an eyedrop for presbyopia is that it's known to have a brow ache or headache side effect in about 20% of patients. And we believe, and our market research shows us, that if we can significantly improve on that, it would do a lot to encourage uptake and eventually choosing the microdose product, our product, and the OptiJet over a traditional eyedropper.
spk09: Yeah, I think that your dosing is, I think, on either side of the Allergan dose, but you deliver less. I was wondering, Apilocarpine, the two doses you've chosen, I was wondering if you could comment on that. And secondly, I think that it's an important point, given that there is a non-medical need for a presbyopia drug and there are alternatives that can be used such that if the patients are experiencing any discomfort of any consequence, they're very likely to revert back to eyeglasses or contact lenses. So I think that that bears great understanding. Thank you.
spk03: Yes, certainly on that second part, we would agree that people don't want to have to feel tied to their reading glasses all of the time, but they're not willing to trade that off for the potential of a headache or a browache. So we're looking forward to coming in pretty clean on there. And as far as the dose itself, we did 1% and 2% because we wanted to see if we could push up efficacy without reducing the tolerability. And we think we can do that. We didn't choose an intermediate dose because unlike with eye drops, we don't have to worry about being substituted with a generic medication. So if I was an eye drop and I had a 1% pilocarpine for presbyopia, I could easily be substituted with a 1% pilocarpine that's used in glaucoma. So to avoid that, I will go to a 1.25%, for example, pilocarpine, and that's how I get around that from a substitution point of view, but because we cannot be substituted in that way, it's not something we need to worry about.
spk09: Great. Thank you.
spk03: Thank you.
spk06: We have reached the end of the questionnaire session, and I'll now turn the call over to Sean Iancelive for closing remarks.
spk05: Okay. Well, that concludes the call today. Thank you again for joining us. We look forward to our first quarter 2021 financial update in May, and I hope everybody has a good afternoon. Thank you.
spk06: This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
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