Earnings Call Transcript - OCUL Q2 2021

Operator, Operator

Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Ocular Therapeutix Second Quarter 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.

Donald Notman, CFO

Thank you, operator. Good afternoon, everyone, and thank you for joining us on our second quarter 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 ended June 30, 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 development 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 developments and pipeline. Following Michael’s remarks, I will provide an overview of the financial highlights for the second quarter before turning the call back over to Antony for his summary and questions. For Q&A, we will be joined by Scott Corning, our Senior Vice President, Commercial; and Chris White, our Senior Vice President, Business and Corporate Development. 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 quarterly report on Form 10-Q filed this afternoon with the SEC. I will now turn the call over to Antony.

Antony Mattessich, CEO

Thank you, Donald, and welcome, everyone, to Ocular Therapeutix' Second Quarter 2021 Earnings Report. It's been a good first half of the year, and I'm proud of the team's efforts as we continue our efforts to build a leading ophthalmology company with therapeutics that have the potential to transform the way common eye diseases are treated. At Ocular, we begin with the end in mind. We first think about the size and dynamism of the disease state in ophthalmology and then consider the key unmet need in that space. It is only then that we apply our technology to the opportunity and determine whether we may be able to build a therapeutic that can meet that key unmet need and become the standard of care. We believe that all of our development programs satisfy these requirements, from the largest opportunity in wet AMD, where we believe our OTX-TKI could become the most durable product on the market to glaucoma where OTX-TIC could solve the problem of patient compliance to dry eye disease for OTX-CSI and OTX-DED could improve the patient experience relative to current therapies. And finally, to DEXTENZA that we believe fulfills the patient and physician desires to have a more convenient drop-free solution for the treatment of post-surgical inflammation and pain. Not only do the product candidates we develop target key unmet clinical needs in their respective spaces, but we have designed them with product characteristics that we believe will lend themselves to more efficient commercialization. All of the therapeutics at Ocular are designed in a medical benefit buy-and-bill products with associated procedure codes. Products with these characteristics are optimized through an account selling approach. Account selling structures can be more targeted than reach and frequency models employed by companies that sell traditional prescription benefit medications. DEXTENZA has been proof of principle whereby we've been able to cover the entire U.S. with a targeted commercial team of less than 50 FTEs and have been able to achieve a positive product contribution within a very short period of time. Finally, as highly innovative and novel dosage forms, the product candidates we are developing have substantial intellectual property protections that are expected to maintain exclusivity well into the future. DEXTENZA is patent protected at least until 2030, and all of our development product candidates have patent applications that are expected to provide protection until 2040 and beyond. It all adds up to a portfolio of product candidates that we believe are highly differentiated clinically that lend themselves to efficient commercialization and have long periods of exclusivity. In keeping with the way we add programs to our portfolio, we see dry age-related macular degeneration as the next great area of opportunity in ophthalmology. Like wet AMD, we also believe that durability will be the key unmet need of the future. In June, we announced an exciting collaboration with Mosaic Biosciences that marks an important step forward for our company and how we approach the discovery and development of therapeutics. Working with Mosaic, we hope to incorporate the discovery of new chemical entities with established mechanisms of action to identify novel therapeutics with superior durability. All innovations developed through our collaboration with Mosaic will be wholly owned by Ocular. As we enter a new collaboration with Mosaic, we are also saying goodbye to our long-standing collaboration with Regeneron. While this collaboration was never a central driver of growth for Ocular, we learned a great deal about how to formulate our proprietary hydrogel with monoclonal antibodies and also about formulating medicines for administration to the suprachoroidal space. Both of these are valuable learnings that will further benefit the key drivers of value in our business, our wholly owned pipeline. With the termination of this collaboration, we are no longer restricted from independently developing anti-VEGF agents for treatment of various retinal diseases. This is a multibillion-dollar market opportunity, which we now have the opportunity to pursue on our own or through partnership with others. We believe collaborations will be a central pillar of our strategy to become a leading ophthalmology company. Moving to DEXTENZA. In the quarter, we achieved $11.1 million in net sales to our distributors for the quarter, representing nearly a 700% increase over the same quarter last year and an approximately 65% sequential increase over the first quarter of 2021. For the second quarter, end market sales set a record of nearly 25,000 billable inserts and approximately 50% sequential increase over the first quarter of 2021. We believe this growth reflects a strong increase in end user demand for DEXTENZA against the backdrop of a return to more normal cataract procedure volumes. In the outpatient prospective payment system or OPPS, proposed rule issued by CMS in July, it was proposed that DEXTENZA receive an extension of its pass-through payment status, resulting in separate drug payments to the end of 2022. If this decision becomes final, it allows us to build on our ongoing dialogue with CMS on DEXTENZA's post-pass-through payment status into the next rule-making cycle a year from now. We continue to believe there are a number of viable pathways that CMS can employ whereby we can ensure patient access to DEXTENZA in the ASCs and HOPDs beyond the pass-through period, and we will keep investors updated on any developments in this area. The proposed Medicare Physician Fee Schedule Rule was also issued in July. The draft rule proposed that our CPT procedural code 03560 for the insertion of a drug-eluting insert into the nasolacrimal canaliculus will convert to a Category 1 code in January of 2022 with a proposed payment of $31.91 in the facility and $37.61 in the physician's office for unilateral insertion. We are very pleased that the Category 1 code conversion for the procedure appears on track since the Category 1 CPT codes typically benefit from broader coverage and payment among all types of payers. However, the work ahead for Ocular and other interested parties is to use the comment period to make the case for a reimbursement level that is more in line with similar procedures. With regard to allergic conjunctivitis, we currently await the October 18 PDUFA target action date for potential approval and expansion of the DEXTENZA label. It is estimated that up to 10 million people in the U.S. annually seek medical attention for the inflammatory response associated with allergic conjunctivitis caused by both seasonal and perennial allergens, representing a discrete and significant potential market for DEXTENZA. Most importantly, if approved, the AC indication may signal the opportunity to transition to DEXTENZA administration in the office setting, providing additional opportunities for expansion of the product. Moving to our pipeline. We have four clinical programs, each of which is geared to produce a highly differentiated ophthalmology specialty product candidate that addresses the key unmet needs in its respective disease state. We believe our pipeline remains a source of tremendous value for Ocular and we anticipate a number of key events over the course of the year. Just recently, we announced the dosing of the first subject in our U.S.-based trial of OTX-TKI for the treatment of wet AMD. OTX-TKI has the potential to be a new sustained release administration of axitinib with six months or longer durability and a potential new mechanism of action for the treatment of patients with wet AMD and other retinal diseases. A few weeks ago, we announced eight company presentations and data from five investigator-initiated trials at the ASCRS annual meeting held in Las Vegas. The scope of our presence highlights the interest in our clinical programs and the progress we continue to make advancing our pipeline. The Company-sponsored presentations and posters are available under the Investors section of our website. Before turning the call over to Mike, I want to highlight two compelling programs in dry eye disease. Dry eye represents a large market that we believe continues to be underserved with products that have high rates of patient drop-off to the slow onset of action and tolerability issues like burning and stinging upon administration. OTX-CSI is our cyclosporine containing intracanalicular insert to increase tear production in patients suffering from dry eye disease, and OTX-DED is our dexamethasone containing intracanalicular insert for the short-term treatment of signs and symptoms of dry eye disease. Both programs are being drilled to address the specific limitations of current treatment options. To date, we are encouraged by our progress and both programs have advanced faster than planned. So it has been a very productive start to the year, and we anticipate a number of important catalysts that will take place over the next two quarters. With that, I would 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.

Dr. Michael Goldstein, Chief Medical Officer

Thanks, Antony. Let me begin with an update on our back-of-the-eye program, OTX-TKI. As Antony noted, we are pleased to have recently dosed our first subject in the U.S.-based multicenter prospective randomized controlled trial that is evaluating a single OTX-TKI implant containing axitinib compared to aflibercept administered every eight weeks in subjects previously treated with anti-VEGF therapy. The U.S.-based Phase I clinical trial of OTX-TKI is being conducted under an exploratory IND application at five sites with a total of 20 randomized subjects, 15 subjects being treated with a single OTX-TKI implant containing 600-microgram dose of axitinib with an anti-VEGF induction injection and five subjects being treated at eight-week intervals with aflibercept. The 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. Based on the early data that we have shared to date in the ongoing Phase I trial of OTX-TKI in Australia, we continue to see signals of biological activity, including decreases in retinal fluid in some subjects as early as two months following implant administration. Additionally, we are seeing encouraging durability of six months or longer across cohorts and durability beyond one year in some subjects. OTX-TKI has thus far been well tolerated and has been observed to have a favorable safety profile. No serious ocular adverse events have been observed or reported to date. While the drug product profile is still emerging, we are pleased with the interim data and OTX-TKI's potential to reduce intraretinal and/or subretinal fluid. Moving to our glaucoma program, OTX-TIC. We have completed a 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. We presented interim data in May at ARVO and in July at ASCRS that showed a mean reduction in intraocular pressure from baseline of approximately 7 to 11 millimeters that is comparable to current standards of care, topical travoprost. We have observed onset of action as early as two days after implant administration and the durability of response with decreases in eye pressure for six to nine months in many subjects in Cohorts 1 and 2 and in four to six months for subjects in Cohorts 3 and 4. OTX-TIC has been generally well tolerated with a favorable safety profile to date. We are targeting initiation of the Phase II clinical trial in the fourth quarter of this year. We are also making significant progress with our ocular surface disease programs, which include product candidates for dry eye disease and allergic conjunctivitis. In dry eye, we have two programs, OTX-CSI for the chronic treatment of patients with dry eye disease and OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease. OTX-CSI is an intracanalicular insert, which offers local programmed release of cyclosporine for approximately three to four months to the ocular surface along with punctal occlusion. By releasing low doses of preservative-free cyclosporine over an extended duration of time, OTX-CSI has the potential to minimize some of the biggest patient complaints about commercially available products for the chronic treatment of dry eye disease, namely ocular surface irritation, stinging and burning. We are very excited about the potential for this physician-administered hands-free and preservative-free option in helping dry eye patients receive the benefits of cyclosporine but with potentially greater tolerability and more rapid onset of action compared with therapies currently available on the market. We have completed enrollment of our U.S.-based randomized masked Phase II multicenter clinical trial evaluating two different formulations of OTX-CSI compared with two different hydrogel vehicle inserts, and approximately 140 subjects will be followed for a period of 16 weeks. End points in this study include increased tear production as measured by the Schirmer's test, other signs of dry disease as measured by corneal fluorescein staining and symptoms of dry disease as measured by the visual analog scale or VAS, eye dryness severity score, and dry eye frequency score. Consistent with our update last quarter, we expect top line data in the fourth quarter of 2021. Our second product candidate in dry eye, OTX-DED, is a low-dose intracanalicular insert of preservative-free dexamethasone. While it incorporates the same active drug as DEXTENZA, this is a new product candidate with a lower dose of dexamethasone and smaller insert size. Many dry eye patients experience episodic flares of their signs and symptoms, which we believe are likely related to inflammation. Topical steroids have long been used off-label for dry eye flares. All commercially available topical steroid eye drops in the United States have preservatives, which can result in ocular surface toxicity. Chronic misuse of steroids may also lead to adverse events such as elevated eye pressure or cataract. OTX-DED potentially offers these patients the opportunity to be treated with a physician-administered, preservative-free, hands-free steroid option that can't be overused by patients. We are currently enrolling patients in a U.S.-based randomized double-masked vehicle-controlled Phase II multicenter clinical trial, evaluating two different doses of OTX-DED compared with a hydrogel vehicle insert in approximately 150 subjects with dry eye disease. This trial is designed to assess the safety and efficacy of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease by evaluating bulbar conjunctival hyperemia, the VAS eye dryness, frequency and severity scores and total corneal fluorescein staining among other end points. Enrollment has been faster than initially anticipated, and we are tightening our guidance as we now expect top line data in the first quarter of 2022 versus our prior guidance of the first half of 2022. Lastly, for DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis, we submitted an sNDA at the end of 2020 and have received a PDUFA target action date of October 18, 2021. Overall, we believe the data package highlights a compelling product profile targeting an unmet need that could potentially change the current standard of care with the physician-administered, preservative-free, hands-free therapy for these patients, which can't be abused by patients. As Antony mentioned, if approved, this sNDA would represent our first in-office indication for DEXTENZA. I would now like to turn the call back over to Donald to review our second quarter financial results.

Donald Notman, CFO

Thanks, Mike. Gross product revenue net of discounts, rebates and returns, which the Company refers to as total net product revenue, was $11.7 million and represented a 631% increase over the same period in 2020. Net product revenue of DEXTENZA in the second quarter was $11.1 million versus $1.4 million in the comparable quarter of 2020, reflecting a nearly 7x increase. Total net product revenue for the second quarter in 2021 also included net product revenue of $0.6 million from ReSure Sealant. Research and development expenses for the second quarter were $13.9 million versus $8 million for the comparable period in 2020, driven primarily by increased headcount as well as increased clinical trial costs associated with the initiation of the U.S.-based Phase I trial of OTX-TKI as well as the ongoing Phase II clinical trials for OTX-CSI and OTX-DED, the ongoing Phase I clinical trial of OTX-TKI in Australia and the DEXTENZA post-approval pediatric trial. Selling and marketing expenses in the quarter were $8.4 million as compared to $6.2 million for the same quarter in 2020, reflecting increased personnel costs associated with the expansion of our field force. Finally, general and administrative expenses were $8.6 million for the second quarter versus $5.1 million in the comparable quarter of 2020. The increase in expenses stemmed primarily from increased personnel expenses and professional fees. With respect to the financial results for the second quarter, the Company reported a net loss of $8.5 million or a loss of $0.11 per share on a basic and a loss of $0.25 per share on a diluted basis. This compares to a net loss of $36.6 million or a loss of $0.64 per share on a basic and diluted basis for the same period in 2020. The decreased loss was due primarily to a $30.4 million net change in the fair value of the derivative liability associated with our convertible note driven by a decrease in the price of our common stock during the quarter. Noncash charges for stock-based compensation and depreciation and amortization were $4.9 million in the second quarter versus $2.5 million for the same quarter in 2020. As of August 6, 2021, the Company had 76.7 million shares outstanding. As of June 30, 2021, the Company had $191.9 million in cash and cash equivalents versus $209.4 million at March 31, 2021. Based on our current plans and related estimates of anticipated cash inflows from DEXTENZA and ReSure product sales and cash outflows from operating expenses, the Company believes that existing cash and cash equivalents as of June 30, 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 second quarter financial results, and I would like to turn the call back to Antony for some final thoughts.

Antony Mattessich, CEO

Thanks, Donald. So before opening the call up for questions, let me do a quick summary. DEXTENZA enjoyed fantastic performance in the quarter with $11.1 million in net sales, growing nearly 65% over the previous quarter. We are pleased with continued progress on our pipeline and our growing presence at key medical meetings like ASCRS that allow us to share our progress. In wet AMD, we dosed the first patient with OTX-TKI in our U.S.-based clinical trial using a single 600-microgram insert. In glaucoma, data from our Phase I trial of OTX-TIC continues to support a durable rapid onset product profile that could potentially set the standard of care for patient compliance. We remain in a position to advance that program into a Phase II clinical trial in the fourth quarter of 2021. In dry eye disease, we are conducting two Phase II clinical trials: one for OTX-CSI and one for OTX-DED. We plan to announce clinical data from OTX-CSI in the fourth quarter of this year and in the first quarter of 2022 for OTX-DED. Beyond dry eye disease, we submitted our sNDA for DEXTENZA in allergic conjunctivitis in December 2020 and have a PDUFA target action date of October 18, 2021. Finally, we announced an exciting collaboration with Mosaic Biosciences. This marks an important step forward for our company and how we approach the discovery and development of ophthalmic products and serves to enhance our current strategy, which includes a pipeline that we believe to be one of the most comprehensive ophthalmology pipelines in the industry today. We look forward to a busy and productive 2021. And with that, I will turn the call over for questions.

Operator, Operator

Our first question comes from Jon Wolleben with JMP Securities. Your line is open. Please go ahead.

Jon Wolleben, Analyst

Congrats on the progress. I appreciate you taking the questions. Just one on DEXTENZA to start. Can you discuss the gross to net in 2Q and then how that dynamic is shifting? And then what do you think the potential outcomes are for the proposed pricing? And when we might get an update on what that funnel pricing looks like?

Antony Mattessich, CEO

Yes. I'll pass it over to Donald shortly. As I mentioned last quarter, our growth was somewhat slower than the overall market growth, and I noted that I wouldn't take too much credit for our performance this quarter, which was better than market growth. There was definitely some stocking that contributed to our higher growth rate this quarter compared to the market. We were growing at 50% in the market and 65% in two markets, but there were some adjustments in the gross to net that Don will elaborate on.

Donald Notman, CFO

Thank you for the question, Jon. Yes, we saw an improvement in our gross to net over the quarter, driven by two main factors. First, in the first quarter, we made an accrual for anticipated rebates in the pipeline for the first time, which was a one-time adjustment and is now normalizing. This resulted in a smaller figure. The second factor is related to product returns. Now that DEXTENZA has been on the market for over a year, we have better data on expected returns, which are coming in significantly lower than initially predicted. Consequently, we have started to decrease the deduction in our gross to net. We expect to stabilize in the mid-20% discount range moving forward, although this will depend on rebate levels as we progress.

Antony Mattessich, CEO

Sorry, Jon, you had a second question?

Jon Wolleben, Analyst

Yes. I was hoping you could walk us through the process of the proposed reimbursement pricing and what those different outcomes might look like for DEXTENZA and the long-term growth.

Antony Mattessich, CEO

That's a very complicated series. You're talking about the continued separate payment in the ASCs and hospitals?

Jon Wolleben, Analyst

Correct.

Antony Mattessich, CEO

There are several ways this can occur. Changes in the status indicator could enable permanent separate payment. For the proposed rule, there is the possibility of maintaining the non-opiate exclusion for products used in surgery that are indicated for pain. It is crucial to have a pain indication and be a non-opiate product eligible for this exception to ensure continued separate payment. The proposed rule's extension to both ASCs and HOPDs gives us access to the complete range of surgical settings under the non-opiate exclusion. Additionally, there are opportunities for the drug's price to be included in a facility payment based on the APC class we end up in after the pass-through period. There are many different paths we could take to support continued separate payment.

Jon Wolleben, Analyst

Okay. And if I could squeeze in a couple on OTX-CSI, I'm looking forward to that data in the fourth quarter. Can you remind us the difference in the two formulations you're looking at? And I know you're still blind to the data, but I was wondering if you could comment on the dropout rate you're seeing so far in the study.

Dr. Michael Goldstein, Chief Medical Officer

Thanks, Jon. This is Mike. So there are two different formulations of OTX-CSI being looked at in two vehicle formulations. So the two CSI formulations have the same amount of drug but have slightly different hydrogel compositions, which lead to slightly different release and dissolution rates. And the two different vehicle formulations, one matches very similar to the two CSI formulations and one is a rapidly degrading hydrogel. So anyway, so we'll see what the results of this. And the second part of your question was?

Antony Mattessich, CEO

Dropout rate...

Dr. Michael Goldstein, Chief Medical Officer

Yes, exceedingly low. So we don't have the whole exact number, but it's exceedingly low at this point.

Operator, Operator

And our next question comes from the line of Joe Catanzaro with Piper Sandler.

Joe Catanzaro, Analyst

Congrats on all the progress. Maybe actually a similar line of questioning here. Wondering if maybe you could speak to DEXTENZA selling trends that you saw in July and whether it reverted back to the sawtooth pattern that you've historically seen in the first month of the quarter? And just maybe more generally, if you could provide just a little bit of guidance around expectations for the rest of the year.

Antony Mattessich, CEO

Yes, Joe, the quarter performed similarly to previous quarters during the rebate program, with two relatively flat months followed by a strong final month. We anticipate this trend to continue. As mentioned earlier, we are contemplating providing guidance on DEXTENZA sales moving forward, but we have not yet made a decision on that.

Joe Catanzaro, Analyst

Okay. Got it. That's helpful. And then with regards to the Medicare proposed fee schedule for 0356T, are there any established fee schedules for press similar procedures that you could reference during the comment period? And I guess I'm thinking about the insertion of just a basic silicone plug and where that falls.

Antony Mattessich, CEO

Right. I mean there are two. There's dilation and then there's insertion of a nondrug plug, and dilation is around $65 just for dilation itself, which is part of the procedure for 0356T, and then insertion of a nondrug plug is closer to $150. So yes, those as comparative procedures certainly would suggest that there's upward movement. Although, the process doesn't really relate to similar procedures, you really have to do it within the logic of the way the RUC actually calculated the payments. I think Mike can add a little more color on how that works.

Dr. Michael Goldstein, Chief Medical Officer

I was going to say it's not as simple as you might think, and that it's the most, as Antony said, the analogous procedure, but there are other procedure codes where you can, for example, probe and then irrigate the nasolacrimal system, and there's a whole series of codes that apply there. So, as he mentioned, there's just an opportunity to compare this to a number of different procedures at a number of different levels.

Joe Catanzaro, Analyst

Okay. Got it. If I could just squeeze maybe one last one in around the termination of the Regeneron collaboration. Could you maybe speak to your view around how the preclinical work was progressing on the program just to maybe help us get a sense of what contributed to Regeneron's decision?

Antony Mattessich, CEO

Yes, we were very pleased with the progress of the work. As we mentioned earlier, we have been fortunate to be involved in this collaboration. The scientists at Regeneron were excellent to work with. Aflibercept is a remarkable molecule that taught us a lot about how to formulate it with our hydrogel. We also learned how to access the suprachoroidal space, particularly in the preclinical model, which could be very significant for us moving forward. We are excited to have participated in the collaboration, but I genuinely believe there are more opportunities available now outside of it than there were within it. We ask you to stay tuned for details on our future plans, especially as we explore various options given the opportunities we see in the market.

Operator, Operator

And our next question comes from the line of Dane Leone with Raymond James. Your line is open. Please go ahead.

Unidentified Analyst, Analyst

This is a question for Dane. Regarding the proposed Medicare Physician Fee Schedule for DEXTENZA, if reimbursement rates are not increased, how might this affect utilization?

Antony Mattessich, CEO

So you're talking about the CPT procedure code? Yes, we, right now, within the system that's within the T code that we have, we're getting reimbursement rates across the MACs that are ranging between $30 in the lowest MAC and $250 in the highest, averaging out about $100. We have not noticed the difference in penetration of total cataract volume among the MACs. So there's really no basis to suggest that, that payment rate would need to be higher in order to get better penetration, although it certainly stands to reason that the higher they are, the more attractive the use of an intracanalicular drug delivery device would be to the doctor. So we think that from a fairness standpoint, that, that should be reimbursed at a higher level. And that's really what drives what we're doing, less so about the penetration that we would expect our drugs to get.

Operator, Operator

And our next question comes from the line of Georgi Yordanov with Cowen and Company. Your line is open. Please go ahead.

Georgi Yordanov, Analyst

So I guess the TKI program, congratulations on the initiation of the U.S.-based trial. Could you discuss, and I guess, remind us of the decision to include a control group in the study? And how should we be interpreting the results from the trial? And then related to that, do you plan to announce interim data? And when should we expect initial efficacy data from this trial?

Dr. Michael Goldstein, Chief Medical Officer

Thank you for those questions. The trial design differs from the Australian trial as we are focusing on a slightly different patient population. In the Australian trial, we are working with patients who have active fluid, assessing whether that fluid can be eliminated, whether it is intraretinal or subretinal. We are observing whether the fluid diminishes. In the U.S. trial, we are targeting a different group: patients with wet age-related macular degeneration who have previously been treated with an anti-VEGF drug. These patients start without fluid, and then we administer the TKI. We are monitoring them, and regarding the control group, we want to understand what would happen if no treatment were given. Thus, a control group is essential for comparison in the trial. The design features a 3:1 randomization, meaning for every three patients receiving the TKI, one will remain on aflibercept. We are aiming to enroll 20 patients, and enrollment has already commenced. Although there is currently no interim analysis planned, we do have the option to review data later, likely early next year, if we decide to do so.

Georgi Yordanov, Analyst

Got it. And then on the glaucoma program, just if you could remind us, once the trial is initiated in Q4, when should we be expecting potential results from this trial? And what would be the plan for registrational studies? Would you need to run two separate pivotal studies? Or is this Phase II trial powered sufficiently to serve one of two pivotal?

Dr. Michael Goldstein, Chief Medical Officer

Yes. So the glaucoma program called OTX-TIC, as you know, is initiating in Q4. We're targeting three different dose groups with 135 subjects. We haven't yet given guidance on how long that trial will take, but obviously, it takes longer to enroll that trial than it will, for example, the dry eye disease trials. It is not powered for statistical significance. So presumably, we would then need to do two Phase III trials after the Phase II trial completes.

Operator, Operator

And our next question comes from the line of Yi Chen with H.C. Wainwright. Your line is open. Please go ahead.

Yi Chen, Analyst

First, can you comment on the potential revenue contribution from DEXTENZA from the allergic conjunctivitis indication once approved?

Antony Mattessich, CEO

We haven't provided any forward guidance regarding our expectations for that indication. It is clearly a strategic focus for us as we enter the office environment, but we haven't released a specific number. We do have some internal forecasts that we believe are reasonably ambitious, and we're very excited about the opportunities that AC presents. However, we haven't shared a figure.

Yi Chen, Analyst

Got it. And regarding the two hydrogel formulations used in the OTX-CSI, are they the same two formulations used for OTX-TIC?

Dr. Michael Goldstein, Chief Medical Officer

No. So in short, no. So we have a number of different PEG formulations that we look at. They are different combinations and every indication, every program, the formulations are different depending on the indication. So yes, there's no overlap really between any of the programs.

Yi Chen, Analyst

So the formulation is also different from the formulation used in DEXTENZA?

Dr. Michael Goldstein, Chief Medical Officer

That's correct. I mean they're all based on a similar case, so the actual compositions are different.

Yi Chen, Analyst

Okay. So with these different formulations, do you expect a different impact in efficacy or safety or both?

Dr. Michael Goldstein, Chief Medical Officer

The focus is on durability. Regarding safety, we believe we have tested all combinations of PEG both on the surface and in the eye, so we do not anticipate any safety differences. Efficacy is primarily concerned with how quickly the drug is delivered over a specific time frame for a given indication. We develop each drug separately to ensure that we align the desired durability with the specific indication we are addressing.

Operator, Operator

Our next question comes from Anita Dushyanth with Berenberg. Your line is open. Please go ahead.

Anita Dushyanth, Analyst

Just wanted to get some clarity on the sNDA for the allergic conjunctivitis. So I mean, considering that the reimbursement will sort of kick in from January, can you sort of give an idea of like what percentage of patients that are in the cataract surgery are also candidates for the allergic conjunctivitis?

Antony Mattessich, CEO

Yes. It's not primarily about the cataract patients being candidates for AC. It's more about the doctors who treat cataracts and how frequently they encounter patients who have already gone through step edits or prior treatments like antihistamines before seeking additional help for allergic conjunctivitis. The overlap in this area is quite substantial; about 90% of the cataract specialists we observe also have high potential in the allergic conjunctivitis arena. While the allergic conjunctivitis opportunity is much more extensive, it doesn't capture all of that potential and actually represents a small fraction of it. However, there are 10 million patients annually who visit physicians seeking a remedy that is more effective than what is available over the counter for allergic conjunctivitis. This is a significant number even for a portion of the total opportunity, making it potentially quite substantial.

Operator, Operator

Thank you. And this does conclude today's question-and-answer session as well as today's conference call. Ladies and gentlemen, thank you for participating, and you may now disconnect. Everyone, have a great day.