Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Ocular Therapeutix Q4 and Year-end 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. It is now my pleasure to turn the call over to Donald Notman, Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir.
Thank you, Catherine. Good afternoon, everyone, and thank you for joining us on our Q4 and Year-end 2021 Financial Results and Business Update Conference Call. This afternoon after the close, we issued a press release providing an update on the company's product development programs and details of the company's financial results for the quarter and fiscal year ended December 31, 2021. The press release can be accessed on the investors portion of our website at investors.ocutx.com. Leading the call today will be Antony Mattessich, our President and Chief Executive Officer, who will provide a summary of our corporate developments and an update on the commercial progress of DEXTENZA. Also speaking on the call today will be Dr. Michael Goldstein, our President, Ophthalmology, and Chief Medical Officer, who will give an update on our clinical development pipeline.
Following Michael's remarks, I will provide an overview of the financial highlights for the quarter and the fiscal year before turning the call back over to Antony for a summary and questions. For Q&A, we will be joined by Scott Corning, our Senior Vice President, Commercial, and Chris White, our Chief Business Officer. As a reminder, on today's call, certain statements we will be making may be considered forward-looking for the purposes of the Private Securities Litigation Reform Act of 1995.
In particular, any statements regarding our regulatory and product development plans as well as our research activities are forward-looking statements. These statements are subject to a variety of risks and uncertainties that may cause actual results to differ from those forecasted, including those risks described in our most recent annual report on Form 10-K filed this afternoon with the SEC. I will now turn the call over to Antony.
Thank you, Donald, and welcome everyone to the Ocular Therapeutix Q4 and Year-end 2021 Earnings Report. Ocular's had another strong quarter and a productive year. The commercialization of DEXTENZA continues to ramp. We achieved $12.3 million in total net product revenues in the Q4 and $43.5 million for 2021. This represents a 66% growth over the comparable quarter in 2020 and a 150% growth in 2021 on a full year basis. I'm pleased with our commercial efforts and our team's ability to grow product revenues in each quarter of 2021, despite lower than expected cataract surgery volumes attributed to the COVID-19 pandemic. DEXTENZA represents a tremendous growth driver for Ocular as we continue to put ourselves in the best possible position to grow the product.
We have made significant progress on reimbursement as we enter 2022, with DEXTENZA currently maintaining pass-through payment status through 2022, and then very importantly, being eligible for separate payment beginning in 2023 and potentially beyond as a non-opioid pain management supply provision in ASCs. In addition, physician reimbursement for the insertion of DEXTENZA is now broadly available under our Category I code, which became effective January 1, 2022, ensuring reliable payment to physicians for DEXTENZA placement across all payer types and in all settings of care.
In October, we received FDA approval of our SNDA, expanding the use of DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. This approval represents an important strategic milestone, not just because it expands the market opportunity for DEXTENZA, but because we believe it opens up growth potential in a new site of care, the ophthalmology and optometric office environments. Allergic conjunctivitis is treated in the office environment as opposed to the ASC and HOPD, where DEXTENZA gets the vast majority of its current use in the treatment of post-surgical inflammation and pain.
Ocular Therapeutix's strategic goal is to expand its presence into ophthalmology and optometric offices by providing customers with numerous innovative buy and bill products, including those developed internally and potentially those in-licensed from other companies in the future. The approval of this NDA gives us the opportunity to take the first step in doing that. While the strategic potential of the office environment is exciting, it represents an almost entirely new space for Ocular Therapeutix with a unique set of challenges and opportunities.
We discovered in the launch of DEXTENZA that the primary barriers of entry were the logistics associated with ASC and HOPD administration. Setting up accounts in ophthalmology and optometric offices will be analogous but with different drivers that require bespoke solutions. As a result, in 2022, we are establishing a separate business unit consisting of key account managers and field reimbursement managers who will be tasked exclusively with selling into the office setting.
This effort will expand our commercial footprint and provide the opportunity to further enhance the growth of DEXTENZA and may also facilitate longer-term the commercialization of any of the product candidates in our pipeline that may be approved, including potentially OTX-TKI in wet AMD, OTX-TIC in glaucoma, and our dry eye products, all of which are designed to be used predominantly in the office setting. Shifting to our pipeline, we have also made great progress advancing our key programs. We recently provided updates on OTX-TKI for the treatment of wet AMD at the Angiogenesis, Exudation, and Degeneration meeting and on OTX-TIC for the treatment of glaucoma at the Glaucoma 360 meeting.
Both updates continue to demonstrate drug product profiles that we believe are compelling and could dramatically improve upon the standard of care in these billion-dollar markets. We anticipate significant milestones in both programs over the course of 2022. Clearly, we believe our pipeline remains a source of tremendous potential value. We continue to advance a portfolio of product candidates that are highly differentiated clinically, that lend themselves to efficient commercialization, and have the potential for long periods of exclusivity. With that, I would now like to hand the call over to our President of Ophthalmology and Chief Medical Officer, Dr. Michael Goldstein, who will provide an in-depth look at our pipeline.
Thanks, Antony. Let me begin with an update on our back of the eye program, OTX-TKI. We are pleased to have recently completed enrollment in the U.S.-based, multicenter, prospective randomized controlled trial that is evaluating a single 600 microgram OTX-TKI implant containing axitinib compared to aflibercept administered every eight weeks in subjects previously treated with anti-VEGF therapy. This U.S.-based phase I clinical trial of OTX-TKI is being conducted under an exploratory IND application at five sites targeting a total of 20 randomized subjects with 3-to-1 randomization weighted toward OTX-TKI treated subjects. We plan to report interim 6-month data in the H2 of the year. This trial is designed to assess the safety, durability, and tolerability of OTX-TKI, as well as to assess preliminary biological activity in subjects by measuring anatomical and functional changes of the retina.
Critical to remember is that the population being studied here is different than the population being studied in our ongoing phase I clinical trial of OTX-TKI in Australia. In this trial, we are including only subjects who have been previously treated with anti-VEGF therapy and asking the question, how long can we maintain subjects without need for retreatment? Whereas in the Australian trial, we studied subjects who had preexisting intraretinal and/or subretinal fluid and asked the question, could we get rid of the fluid with the TKI? We recently presented the interim data on OTX-TKI from the Australia-based phase I trial at the Angiogenesis, Exudation, and Degeneration 2022 meeting held on February 11th and 12th.
This latest analysis of interim data in subjects with subretinal and/or intraretinal fluid due to wet AMD continued to support the product safety profile and preliminary evidence of biological activity. In this trial, we found a clinically meaningful decrease in intraretinal and/or subretinal fluid in many subjects. Extended duration of activity of 6 months or more was observed in over 60% of subjects across all cohorts, and over 80% of subjects in cohort 3A, the 600-microgram cohort, which could represent a compelling drug product profile. Moving to our glaucoma program, OTX-TIC. We recently presented data from the completed U.S.-based phase I clinical trial evaluating the safety, biological activity, durability, and tolerability of OTX-TIC in subjects with primary open-angle glaucoma or ocular hypertension at the Glaucoma 360 meeting on February 11th.
The phase I data presented highlights OTX-TIC's ability to provide a clinically meaningful decrease in intraocular pressure comparable to travoprost as early as two days following administration and for as long as six months or more with a single implant while preserving corneal health, representing its potential for a unique and differentiated drug product profile. With this data in hand, we've initiated a U.S.-based phase II clinical trial and are actively screening subjects. This trial is a prospective multicenter randomized controlled trial evaluating the safety, tolerability, and efficacy of OTX-TIC for the treatment of patients with primary open-angle glaucoma or ocular hypertension.
The trial will enroll approximately 105 subjects in three different arms, 35 subjects per arm randomized 1:1, in which the subjects will receive a single OTX-TIC implant containing a 5-microgram or 26-microgram dose of travoprost compared with an injection of DURYSTA. The trial will observe the changes in diurnal intraocular pressure, changes from baseline at 8:00 A.M., 10:00 A.M., 4:00 P.M. at 2, 6, and 12 weeks, and follow duration of IOP response over time. Regarding our ocular surface disease programs, we remain committed to the development of our two dry eye programs, OTX-DED, a low-dose intracanalicular insert of preservative-free dexamethasone for the short-term treatment of the signs and symptoms of dry eye disease, and OTX-CSI for the chronic treatment of patients with dry eye disease.
In December of 2021, we announced positive top-line results from our phase II clinical trial of OTX-DED. The phase II clinical trial was a U.S.-based randomized double-masked vehicle-controlled multicenter trial evaluating two different formulations of OTX-DED, a 0.2 mg group and a 0.3 mg group in 166 subjects with dry eye disease. While not powered for statistical significance, the clinical trial achieved its pre-specified primary endpoint, demonstrating a statistically significant change of bulbar conjunctival hyperemia from baseline to day 15 compared to the vehicle hydrogel using a central reading photographic assessment in the modified ITT population at both doses. P-value of 0.004 in the 0.2 mg group and P-value of 0.028 in the 0.3 mg group. OTX-DED was observed to be generally well-tolerated with a favorable safety profile.
Overall, we are pleased with the OTX-DED results, and we continue to see a large treatment effect from the punctal occlusion used in the control arm. We are currently reviewing an appropriate clinical regulatory development and manufacturing plan. This plan will include some additional formulation work for the OTX-DED insert and the development of an appropriate vehicle comparator. In late October of 2021, we reported top line data from the U.S.-based phase II randomized double masked multicenter clinical trial to evaluate the safety, efficacy, durability, and tolerability of two different formulations of OTX-CSI versus hydrogel vehicle insert. The phase II study showed that OTX-CSI treated subjects had a clinically meaningful improvement from baseline for both signs and symptoms of dry eye disease for both formulations.
This trial, however, did not show separation between the OTX-CSI treated subjects, both formulations, and the vehicle treated subjects, both formulations on symptoms or the primary endpoint of increased tear production at 12 weeks as measured by the Schirmer's test. We are currently reviewing an appropriate clinical regulatory development and manufacturing plan. This plan will include additional formulation work for the OTX-CSI insert to allow improved retention and the development of an appropriate vehicle comparator. I would now like to turn the call back over to Donald to review our Q4 and year-end financial results.
Thanks, Mike. Gross product revenues net of discounts, rebates, and returns, which the company refers to as total net product revenue, was $12.3 million for the Q4 and represented a 66% increase over the same period in 2020. Net product revenue of DEXTENZA in the Q4 was $12.2 million versus $6.9 million in the comparable quarter of 2020, reflecting a 77% increase. Total net product revenue for the Q4 of 2021 also includes net product revenue of $58,000 from ReSure Sealant. Overall, net product revenue for the year was $43.5 million versus $17.4 million for 2020, reflecting a strong uptake in DEXTENZA sales.
Research and development expenses for the Q4 were $12.6 million versus $7.6 million for the comparable period in 2020, driven primarily by an increase in unallocated expenses, predominantly personnel costs and increased clinical trial costs associated with the initiation of the U.S.-based phase I clinical trial of OTX-TKI and the initiation of the U.S.-based phase II clinical trial for OTX-TIC, the phase II clinical trials for OTX-CSI and OTX-DED, the ongoing phase I clinical trial of OTX-TKI in Australia, and the ongoing post-approval clinical trial for DEXTENZA for post-surgical inflammation and pain in pediatric subjects. Overall, R&D expenses for the full year increased $21.4 million to $50.1 million from $28.7 million in 2020, reflecting the trends identified above.
Selling and marketing expenses in the quarter were $9.1 million as compared to $6.8 million for the same quarter in 2020, primarily reflecting increased personnel costs associated with an expansion of the field force. Overall, selling and marketing expenses for the full year increased to $35.2 million from $26.6 million in 2020, driven primarily by increased personnel costs and increased spending on consulting, trade shows, and conferences. Finally, general and administrative expenses were $7.5 million for the Q4 versus $6.6 million in the comparable quarter of 2020. The increase in expenses stemmed primarily from increased personnel expenses and professional fees.
Overall, G&A expenses for the full year increased $9 million to $31.9 million from $22.9 million in 2020, again reflecting primarily increased personnel and professional fees. With respect to the financial results for the Q4 , the company reported a net loss of $3.9 million, or a loss of $0.05 per share on a basic basis, and a loss of $0.23 per share on a diluted basis for the three months ended December 31, 2021, as compared to a net loss of $85.6 million or a loss of $1.21 per share on a basic and diluted basis for the same period in 2020.
Net income in the Q4 of 2021 included a $15.9 million non-cash gain in the fair value of the derivative liability associated with our convertible notes, driven by a decrease in the price of our common stock during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization were $4.4 million in the Q4 versus $2.8 million for the same quarter in 2020.
Overall, the company reported a net loss of $6.6 million or a loss of $0.09 per share on a basic and a loss of $0.98 per share on a diluted basis for the full year ended December 31, 2021 versus a net loss of $155.6 million or a loss of $2.56 per share on both a basic and diluted basis in 2020. As of February 24, 2022, the company had 76.8 million shares outstanding. As of December 31, 2021, the company had $164.2 million in cash and cash equivalents versus $179.3 million at September 30, 2021.
Based on our current plans and related estimates of anticipated cash inflows from DEXTENZA and anticipated cash outflows from operating expenses, the company believes that existing cash and cash equivalents as of December 31, 2021 will enable the company to fund planned operating expenses, debt service obligations, and capital expenditure requirements through 2023. This cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, the revenues, expenses, and reimbursement associated with DEXTENZA, and the pace of research and clinical development programs, among other aspects of the business. This concludes my comments on our Q4 2021 and year-end financial results, and I would like to turn the call back to Antony for some final thoughts.
Thanks, Don. Before opening the call up for questions, let me give a quick summary. The company demonstrated solid performance, growing total net revenue 66% over the comparable quarter of 2020 and approximately 150% in 2021 on a full year basis. With FDA's approval of our SNDA to include ocular itching associated with allergic conjunctivitis in the DEXTENZA label, we are establishing a separate commercial business unit consisting of key account managers and field reimbursement managers to focus exclusively on the office setting while the main sales team continues to focus on maximizing the opportunity for DEXTENZA in the surgical setting. With the recent OPPS final rules, CMS has laid out a path for the continued separate payment for DEXTENZA in the ASC environment after the path through expiration.
This could allow us to maintain and strengthen our surgical business as we build a new source of growth in the office environment. The U.S.-based trial of OTX-TKI, evaluating a single 600-microgram implant versus anti-VEGF injection versus standard of care every 8-week EYLEA, is now fully enrolled, and we expect to announce interim data in the H2 of 2022. We recently initiated our phase II clinical trial, OTX-TIC, for the treatment of glaucoma and are actively screening subjects.
In dry eye disease, we remain dedicated to developing this key market, and we are conducting work to find the best formulations and vehicle control to use as we look to advance both OTX-CSI and OTX-DED. Finally, the company ended the quarter with $164.2 million in cash on the balance sheet as of December 31st and expected cash runway through 2023. We look forward to a strong 2022. With that, I'll turn the call over for questions.
Thank you. To ask a question, you'll need to press star one on your telephone. To withdraw your question, press the pound key. Our first question comes from Joe Catanzaro with Piper Sandler. Your line is open.
Hey, guys. Thanks so much for taking my questions here, and congrats on the progress. Maybe the first one for me I had on DEXTENZA and expectations for 2022 and whether you would expect to provide billable unit data on a monthly basis in the absence of any firm revenue guidance and what we should think about as we think about modeling DEXTENZA. If you could walk through some of the maybe tailwinds and headwinds that we should keep in mind for the year. Thanks. I have a follow-up.
Yeah. We have consistently given the monthly in-market insert numbers. I mean, that number is also in the earnings report. So until we start giving guidance going forward, we'll continue to give those numbers. I mean, essentially, the real headwind is the questions around the ability of ASCs to be able to staff up appropriately to handle the backlog of cataract surgeries that we understand are very much out there and going to come back into the market at some point. We mentioned before that we had a really good October and November, really strong uptake in sales, and we saw the slowdown in December that followed the lower than expected number of cataract surgeries due to the Omicron upswing.
We saw that continue into January, but we have seen in February a bounce back starting in the market as well. If we understand that going forward, we're not only going to get a normal flow of cataract volume, but can in fact see that some of those delayed surgeries reenter the market. We're actually looking forward to a very good 2022. Once we have some transparency of what that market is gonna look like, we'll revisit the idea about giving guidance.
Okay. Got it. Thanks. That's helpful. Maybe if I could ask one to Mike. I know there was a recent phase III extended VEGF wet AMD study that recently read out and wondering if you see any learnings there, whether it be on trial design, enrollment criteria, or even how EYLEA performs. Any thoughts you have there would be great.
Yeah. Thanks, Joe. I think you're talking about the recent Kodiak trial. I guess the key learning is that getting longer duration therapy with an anti-VEGF monoclonal antibody is challenging and continues to be challenging. I think if someone can get that to work, then that's a huge opportunity. I think one of the biggest learnings is, and we've always believed this, that it's really tough to get a monoclonal antibody to have an extended duration beyond two or three months. You know, we're committed. We believe that having a potent small molecule TKI is a really interesting approach.
Based on the data we've already shown from the Australian trial where we really enrolled some of the more challenging patients and were able to show, you know, essentially with monotherapy that we could get rid of fluid and we can maintain that for six or more months. It's super exciting for us. We have the U.S. trial now, which is, you know, really enrolling a more similar population to what you see with other U.S. trials, where you're coming in with patients who are either getting three injections up front as they did in the Kodiak trial, or in our case, they're coming in pre-treated, and then you're asking the question, can you maintain that? We think that's a much lower bar than we've already shown in the Australian trial.
Okay. Got it. Thanks. That's helpful. Thanks for taking my questions again.
Thanks, Joe.
Thanks, Joe. Talk to you later.
Thank you. Our next question comes from Jonathan Wolleben with JMP Securities. Your line is open.
Hey, guys. Thanks for taking the questions and congrats on the progress. Just wondering for a little more color on the allergic conjunctivitis business unit. First, just wanted to confirm whether or not there's any sales in AC in this $12.2 DEXTENZA number for the Q4 , and then hoping you could give us a little more color on the size of this business unit and what your expectations might be for the contribution to the top line in AC this year.
John, no, we don't expect there have been many or any ASC sales in that $12.3 number that we put in in the last quarter. What we're doing initiating this quarter, and we'll start next quarter, is a fully dedicated team in the office environment. That team initially is going to be very small. So we're talking about five key account managers, probably one dedicated field reimbursement manager, and then a leader of that team. What we would like to do in that environment is to understand what the drivers are in the office environment, how we need to adjust our programs to make sure that they're fit for purpose.
As we start to understand what that opportunity is, we will invest behind that opportunity. Rather than set forth a number that we expect to hit and then resource to hit that number, we've done what we did with the launch of DEXTENZA, which is get in the market, get to understand what drives the market, and then invest once we have the formula correct. We're gonna do exactly that in the office and optometric environment as well. There's not really a number that we're chasing, but we're trying to decode the system, and then once we understand it, we will fund it.
Got it. That's helpful. Just one on OTX-TKI. I know you're enrolling a cohort 4 in Australia. That could be a nice sneak peek of what to expect in the H2 of this year from the U.S. study. Given that's open label, will you be releasing any of that data ahead of the U.S. data?
That's a good question. We are enrolling a cohort 4, which has the single implant, 600 microgram. You know, as you know, at the Angiogenesis meeting, we revealed the results from the cohort 3, which is the 600 microgram, but it was the 3/ 200-microgram implants to get there. We actually don't think it's gonna be meaningfully different. It could be, but we don't think it will be. You know, I think if we've got something meaningfully to say in terms of cohort 4 in Australia, then there is an opportunity to give an update, you know, on the open-label trial.
As you mentioned, the U.S. trial, because it's a masked trial, we really need to wait the time. Now we do have the opportunity for protocol to do an interim analysis, which, as I mentioned, we anticipate to do after all or most of the subjects have hit six months or longer, which we think would be a meaningful time to take a look at that.
Got it. Thanks for taking the questions.
Thanks, John.
Thanks. Thank you. Our next question comes from Dane Leone with Raymond James. Your line is open.
Hi. Thank you for taking the questions, and congratulations on the updates and outlook for 2022. Two questions for me, please. Firstly, as you get closer to having that six-month data from the 600 microgram single insert in the U.S. study, what's been the feedback coming out of Angiogenesis in terms of where you think the hurdle is clinically for that six-month duration of retreatment needed retreatment standard of care? Is it a percentage of patients?
Is it defined by the type of patient and the prior treatment history? Because that's been one of the major points of debate. So any thoughts there would be appreciated. Secondly, it does seem like you're trying to rework the dry eye program a bit, both with the cyclosporine and low-dose DEX. Is there kind of a timeline where you think you might be able to reengage some phase II studies with that program? Thank you.
Yeah. Thanks, Dane. That's a good question as always. In terms of OTX-TKI, I think the number is really a trade-off depending on the safety signal you're seeing. Given that, you know, to date, we've been pleased with the strong safety signal we've shown with OTX-TKI. You know, we think something around 50% of subjects getting to six months or longer is a reasonable clinical target. Now if you look at our 600 microgram data from cohort three, we actually were up around 80% of subjects. If we can replicate that in the U.S. trial or something like that, we'd be really happy.
Again, just to point out what I've said before, the Australian trial started with patients who had a lot of fluid, and we were trying to get rid of that fluid with the TKI. That's something that no one else has done that we know of and no one else continues to show. We think that's a much higher bar, and we've actually been able to show some subjects where the fluid's gone away completely, and we've maintained that out to six months or longer. The US trial, more similar to what others are doing, is starting with patients who are treated or who, you know, in other cases, where people have gotten loading doses and seeing if you can maintain people in that dry state for a longer period of time.
Frankly, we'd be pretty disappointed if we don't hit 60% or higher when we go to the 600-microgram single implant in the U.S. trial. We will find out in the near future. I guess we'll find out in the near future. I think if we hit that target, that's a blockbuster, given the safety profile. If we had a lot of inflammation, if you had a lot of endophthalmitis, if you had vasculitis, the equation changes. Assuming you have a strong safety profile, we think being north of 50% is a very compelling potential option. The other point I should make, not to be lost here, is that the implants go away completely without the need for removal.
You know, one of the concerns that people have with long duration therapy is that they can hang around for a long period of time. You know, that's something we've shown that consistently across all our programs is that the hydrogel goes away in a consistent pattern, and we've seen that with TKI. If you have something that's safe and you know it's gonna go away, it gives you a lot of leeway in terms of the efficacy side of things. To answer your dry eye questions, they're a little bit different but a little bit similar. Both the DED and the CSI showed some interesting information that we showed from the phase II trials.
I think in both cases there's some reworking that needs to be done, some very mild formulation tweaks in DED, some larger formulation tweaks with CSI. The real work for both of those is thinking about the comparator. What we know is that you can't use a sham as the comparator, but there are different options in terms of the hydrogel that we use. There's some work that needs to be done to optimize the comparator. From a regulatory perspective, it's really about the separation between the active and the comparator. Those are plans that are on the way. We're committed to revealing what that plan will look like sometime in the Q2 . You know, we wouldn't anticipate phase II trials starting in either program anytime in the real near future.
Let me add-
Thank you very much.
Mike's point on that. I mean, the one thing we understand in this area is that these trials in dry eye particularly are very high-risk trials. We wanna make sure is that we thoroughly mine the data that we have from our phase II and also understand the process by which we can scale up on both the vehicle and the active drug size, with an eye toward the preservation of our cash runway. There are ways that we could always bring that forward, which will obviously increase the risk of those trials.
What we'd rather do is do it absolutely the right way and make sure that we have the appropriate vehicle, and we have the appropriate actives in both CSI and DED, and start trials that we have full confidence in are going to be able to yield results that can lead to registerable products. We could go one of two ways. We could either go very short term and get into the clinic as quickly as possible, or we could take a longer road and lower risk with lower cash burn. We are definitely leaning toward the lower risk and lower cash burn side.
Thank you.
Thank you. Our next question comes from Yi Chen with H.C. Wainwright. Your line is open.
Thank you for taking my questions. First question is regarding the new sales unit for the office setting use of DEXTENZA. Are those people new hires, or they are, you know, your existing reps and they're just being allocated to the new team?
They will likely be a mix. We don't have the team in place yet, but what we've done is we've opened up vacancies that the surgical team is allowed to apply for. My guess is in the end it'll turn out to be a mix of new hires and existing people within the surgical team.
Okay. Do you expect the company to start recognizing revenue from DEXTENZA for AC in the current quarter or the Q2 ?
I think it'll ramp slowly in the Q2 . Once we crack the code about the proper way to sell DEXTENZA in the office environment, we will layer on resources as needed. I would expect in the latter part of the year, and certainly in the beginning of 2023, to really start to see the ramp-up in that office environment.
I mean, assuming there's a there there, 'cause once again, we're starting with a small team that's trying to look for the pressure points in that environment. We believe that it's there. There's a tremendous reservoir of unsatisfied patients, and there's a great need in the office environment for a buy and bill product for the front of the eye that has a procedure code attached. The ingredients are right. We just need to figure out what the right alchemy is.
Okay. For the wet AMD indication, for those patients who do not respond well to anti-VEGF therapy, do you think there's a chance they can possibly respond to OTX-TKI?
Yeah. I think there is. I mean, as you know, TKIs have a broader spectrum of activity compared with currently available anti-VEGF drugs. So it is certainly possible that those patients who don't respond well to anti-VEGF drugs will respond well to TKIs. That said, you know, the U.S. trial is enrolling patients who are responding well to anti-VEGF drugs. So we're not selecting for those patients who don't respond. The Australian trial is a bit of a mix and, you know, we've got some patients who are naive, some who responded well to anti-VEGF and some who didn't have great responses to anti-VEGF.
Got it. For the glaucoma trial, do you still expect the trial to complete enrollment in the H2 of this year?
We haven't given guidance on when we expect enrollment to finish. I think it's you know about 105 patients. Finishing this year, I think, would be an aggressive target. I think we'll you know see how enrollment goes, and as we go, we'll give an update at some point with appropriate guidance. I think it would be unrealistic to expect enrollment to fully enroll this year.
Okay. Thank you.
Thank you.
Thanks, Chen.
Thank you. As a reminder, if you would like to ask a question, press the star then one key on your touchtone telephone. Our next question comes from Anita Dushyanth with Berenberg Capital. Your line is open.
Hi. Good afternoon. Thanks for taking my question, and congrats on the progress. Just two for me here. I know you spoke about the next steps in the DED and CSI candidates. Could you please talk about maybe the timelines associated with the development, especially now that you are working internally to develop a comparator?
As I mentioned, Anita, we'll reveal the appropriate clinical regulatory and manufacturing plans in the Q2 of this year. That'll be the time to give an update on guidance. We don't anticipate starting a phase II trial in either program in the near future for the reasons Antony mentioned previously.
Okay. Thank you. What are some of the metrics that you probably look at in terms of the backlog that will be addressed with the surgical procedures that use DEXTENZA?
Well, the metrics are essentially that there's usually in a normal year, around 4 million cataract surgeries that are done in the United States. We believe that in 2021, that number was closer to 3 million. Because cataracts don't spontaneously resolve and you at some point are going to need these to get the cataract done, the assumption is that those 1 million or so cataracts that weren't done in 2021 will sprinkle themselves in the latter half of 2022 and early 2023. You know, just giving rough numbers, you would expect $4.5 million this year and probably another $4.5 million or more next year, which would give us a really nice bump on a basis of what we saw in 2021.
Okay. Thank you. That was helpful. The last question is, are there any updates from the, your collaboration with, Mosaic Biosciences?
That's a good question. So that collaboration is to develop a longer duration drug in the dry AMD space, and it's going extremely well. It's on target and, you know, we hope to develop a you know a new candidate you know at some point in the near future.
Okay. Okay. Thank you for that.
Thanks for the questions. Thanks.
Thank you. That's all the questions we have. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.