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EyePod: The Dry Eye Pipeline Is More Than A Topical Discussion
William B. Trattler, MD, highlights some of the novel therapies for dry eye that have recently been approved by the FDA, along with various treatment approaches that are in development.
In this EyePod® podcast episode, William B. Trattler, MD, sits down with Sheryl Stevenson, Ophthalmology Times®' group editorial director, to highlight some of the novel therapies for dry eye that have recently been approved by the FDA, along with various treatment approaches that are in development.
The views and perspectives expressed are those of Dr. Trattler.
Editor's note: This transcript has been edited for clarity.
Sheryl Stevenson: Hi, everyone, and welcome to this episode of the Ophthalmology Times® EyePod® podcast series. This is Sheryl Stevenson, group editorial director with the Eye Care Group here at MJH Life Sciences. It's been a busy first half of the year for the ophthalmology community in terms of FDA approvals and innovations within the dry eye space. Dr. William Trattler, who is a refractive, corneal and cataract eye surgeon with the Center for Excellence in Eye Care in Miami, Florida, joins me for this EyePod® podcast discussion on some of the many treatment approaches and advancements for physicians and their patients with dry eye. It's not an exhaustive list of all that is in development, but it does speak to the depth of the pipeline. Let's take a listen…
Stevenson: Hi, Dr. Trattler. It's so nice to have you join us today. I'm so excited to talk about dry eye and ocular surface disease. There's so much going on in this space right now. It's a delight to have a chance to chat with you about some of these developments.
William B. Trattler, MD: Thank you so much, Sheryl. I just love all the new technologies, because we need them. We have a lot of patients that really need a lot of help. While many of our patients do just fine with what we have available now, these new advances are really going to make a big difference for a lot of patients. So I'm very, very excited and optimistic that we're going to get a lot of help in the near future. So I'm very excited.
Stevenson: Yeah, for starters, there were two recent approvals in the month of June, as you well know. So we had Novaliq with their approval of CyclASol, [Vevye], which is now approved for [the treatment of the signs and symptoms of] dry eye disease.
Trattler: It's so exciting. We're really excited to work with Novaliq technology. It's a new version of a drop where it's really waterless, which it sounds strange. It's a drop that doesn't have water or oil in it. It just contains either just lubricants or actually lubricates and contains a medication like cyclosporine. The fact that we're going to have this to available to our patients...Hopefully this will be helpful just to make the patients feel better, but then also give that extra treatment of an anti-inflammatory to help with their dry eye. So I'm very excited for this approval.
Stevenson: Yeah, and then right around the same time we had Miebo from Bausch + Lomb and Novaliq also approved earlier this month.
Trattler: Yes. This technology is really going to make a big difference. We have so many patients that their eyes just don't feel good. We've tried so many different things to make them feel better...Anti-inflammatories, different lubrication drops, and I'm really hopeful that this will fill in the gap for a lot of these patients that just are uncomfortable. It was kind of geared towards patients with more than a Meibomian gland dysfunction type of situation where they have a rapid tear film breakup. Hopefully, this is going to help just lock in the moisture in the eye as almost an outer layer and really make these patients feel a lot better. So I'm very excited for our patients to have this available.
Stevenson: Yeah, and dry eye...There's just more and more options becoming available and different ways of looking at it. It used to be treated almost like a nuisance disorder, but now it's just becoming more understood with continuing research into the corneal surface. It's even been connected to neuro-ophthalmology disease. There's all kinds of things going on. Allgenesis [Biotherapeutics] has AG-80308, which is also in development. Any thoughts on some of these other therapies that are in the works?
Trattler: I'm really excited. Let's go back to the basics, which is, that dry eye is very complex. We have aqueous-deficient dry eye; we have the poor tear film quality version of dry eye; we have Demodex, which is also a major issue that is also associated with dry eye. We have all these different factors that are really affecting these patients. Oftentimes we focus on one area, and we need help in other areas. All these extra technologies that are getting approved, they're going to help us treat the patients. Sometimes it's going to be more helpful for one type of patient than the other. But overall, having these new technologies available will make a big difference.
For the Allgenesis technology, I'm obviously very optimistic. I don't know a lot about this technology. It's still very early on in development, but it's really I'm hoping will treat the inflammation linked with dry eye disease. I'm really hopeful that's going to be a helpful technology for us. It still has a way to go. We know inflammation, whether it's from aqueous-deficient dry eye or poor tear film quality dry eye, we know that inflammation is underneath it all. Anti-inflammatories are quite helpful for these patients.
Stevenson: Right. There's so many other things. Obviously, we know nutritional strategies have always been in place...The importance of omega-3s and so forth. There's also an oral probiotic that was recently presented at the American Society for Microbiology had a presentation about that as well. There's so many different aspects to this and even neuro-optometry and neuro-ophthalmology clinics are looking at this. What are your takeaways from some of these different approaches?
Trattler: Well, I think you're clearly right. It's not just one approach for dry eye. We need to take different approaches and every patient is unique. They have different factors impacting their overall health of their eye... Again, there are different types of dry eye. We're actually utilizing a technology that's somewhat new as well, it's recently launched, called CSI Dry Eye. It actually uses artificial intelligence to help us categorize the patient into different versions of dry eye so we can more effectively provide effective treatments in first round. It's early work with this company. It looks very exciting with them. With what you just presented on the oral impact...We know that omega-3s for a while have been helpful. The concept of probiotics sounds really interesting and not something I would have expected that a probiotic can help with dry eye disease. But again, there's always room for us to learn more and more. So I'm looking forward to seeing more results on these new technologies.
Stevenson: Yeah, and that's not it. We're not done yet, right? We've got more PDUFAs coming. There's a PDUFA date of November 23. Aldeyra [Therapeutics], they have reproxalap for the treatment [of the signs and symptoms] of dry eye disease. So that's also something in the pipeline to look forward to.
Trattler: Yes. I consult with pretty much all the dry eye companies. It's just probably best for me to say it that way, including Aldeyra. I've had a chance to understand a bit more about this company, just because I've looked into company. I don't have anything confidential from them. It looks really promising. They just released their Phase 3 results from their allergic conjunctivitis study, which often goes hand in hand with dry eye disease and will prove to be quite effective in that scenario as well. Aldeyra's is like an anti-inflammatory that suppresses inflammation, but doesn't have some of the side effects of steroid drops. We're really hopeful that it'll really be an impactful treatment for patients with dry eye by suppressing inflammation and making patients feel better. The clinical trial results have been really positive, and we're hoping for approval to give our patients more opportunities for treatments in the future.
Stevenson: As a clinician in this area, I'm sure you must be super excited about all these developments and just looking forward to having these in your regimen to offer to patients with dry eye disease. Just to have as we progress forward into more and more and learning more about dry eye disease and even other approaches.
Trattler: It's so critical because, again, we often catch dry eye early. It's easy to treat patients who have early dry eye disease, and we can manage this quite nicely with what we have available today. There are patients that have more moderate to severe dry eye that we're still struggling with, and we'll come up with different treatment plans and sometimes it'll be effective and we feel really positive. But sometimes they start better and then they get worse again, and okay, now what do we use next. We're kind of running out of options sometimes. Having these new technologies become available will help not only their patients with early disease, but also patients with moderate to severe disease. We're really excited that we have more options for our patients.
Stevenson: Absolutely. Is there anything else that you'd like to add that we have not even touched upon?
Trattler: This is a great overview of some of the new things that are coming out in the near future. Another company's product, Tarsus, is hoping to get approval soon for Demodex, which is associated with poor tear film quality dry eye. I just think that 2023 is going to be really strong year for our patients. When we get into 2024, we'll have just so many more choices for our patients and more ways that we can help them, and I really am very appreciative of all the work that's being done by all the companies and researchers to help bring these technologies to our patients.
Stevenson: That's right, as you say, I mean, we're only halfway through the year and look at all that's already happened. There's so many developments and really encouraging therapies going on. Who knows what the next 6 months will bring and even beyond. We're really well positioned for growth in the coming months for sure.
Trattler: Yes, absolutely. Thank you so much for having me and I can't wait to talk again to share the next round of exciting news.
Stevenson: Yeah, absolutely. Thank you so much for your time today, Dr. Trattler.
Keep A Close Eye On Jack Smith's Percolating Jan. 6 Probe
A lot of things happened. Here are some of the things. This is TPM's Morning Memo.
Summertime Indictments?With the Mar-a-Lago indictments secured, it's time to check back in on Special Counsel Jack Smith's investigation of the higher-ups in the conspiracy to overturn the 2020 election.
A spate of new reporting over the last 72 hours suggests Smith's Jan. 6 probe remains quite active even as his office handles the MAL case. Immunity deals are a big deal and suggest a willingness to sacrifice convictions of mid-level wrongdoers in favor of securing evidence against top-tier culprits:
Both CNN and the NYT report that the pace of activities by the Jan. 6 grand jury has picked up in recent days, after a period of relative quiescence. CNN puts a finer point on it, noting that Smith's office isn't giving witnesses a chance to postpone their testimony:
Prosecutors have played hardball with some of the witnesses in recent weeks, refusing to grant extensions to grand jury subpoenas for testimony and demanding they comply before the end of this month, sources said. In the situations where prosecutors have given witnesses immunity, the special counsel's office arrived at the courthouse in Washington ready to compel their testimony after the witnesses indicated they would decline to answer questions under the Fifth Amendment, the sources added.
A caveat that the dribs and drabs that emerge from counsel for defendants and witnesses aren't necessarily a good reflection of where the case actually stands – and that while it may appear from some vantage points that the probe slowed then quickened, that may not be the same impression from every vantage point.
Jack Smith Tries To Fast-Track MAL CaseA round of motions filed late Friday by Special Counsel Jack Smith in the Mar-a-Lago case gives us a more reasonable picture of the timeline for a trial of former President Trump and suggests again that Smith and his team are keenly aware of the time pressures they're under with the 2024 election looming.
Smith is asking for a Dec. 11 trial date, a more realistic timeframe than the August placeholder the judge penciled in originally. That will give the judge time to consider all the various pre-trial motions under the Classified Information Procedures Act, which Smith kicked off with a primer to the judge and a request for a CIPA hearing soon.
Trump will, of course, try to delay the trial. Think of this as a strong opening bid by Smith that will get negotiated down some. U.S. District Judge Aileen Cannon helped Smith with an aggressive initial placeholder, but it's not clear yet how quickly she'll decide to move things along.
Informed reaction from a former DOJ official who was a top attorney on Special Counsel Robert Mueller's team:
The Evidence That Tipped The Scale In The MAL CaseWSJ:
What turned the tide was an audio tape and other evidence investigators confirmed around February from meetings Trump held almost two years earlier and a thousand miles from the former president's Palm Beach, Fla., resort, according to people familiar with the matter.
That crucial evidence, along with notes from a Trump lawyer describing his response to the investigation, helped spur prosecutors to push forward with a criminal case, the people said—an unprecedented step that might have been avoided if Trump had cooperated even late last year, as some of his lawyers had urged him to do.
House GOP About To Go Crazy Over Merrick GarlandFormer President Trump is using the House GOP majority as a spear in his multi-pronged attack on the rule of law to save his own skin – and Speaker Kevin McCarthy is happy to go along, even if that means trying to impeach Attorney General Merrick Garland over his handling of the Hunter Biden prosecution.
Just a reminder: Garland left the Trump-appointed prosecutor handling the case in place, gave him full charging authority, and arguably gave him more autonomy than a special counsel.
Rudy Sanctioned By JudgeBloomberg:
Rudy Giuliani was ordered to pay the attorney fees of two Georgia election workers suing him for defamation, after a judge found he failed to comply with his obligations to turn over evidence in the case.
US District Judge Beryl Howell entered an order on Friday directing Giuliani to cover what it cost the lawyers for Ruby Freeman and her daughter Wandrea "Shaye" Moss to pursue their successful motion to compel him to produce information.
Trump Coughs Up $5.5M In Carroll Defamation CaseSo that he can appeal E. Jean Carrol's $5 million defamation and sex abuse judgment against him, former President Trump has deposited $5.5 million with a New York federal court in lieu of an appeal bond.
Don't Sleep On SmartmaticRolling Stone: Newsmax Staffers Hit With Subpoenas in Smartmatic's 2020 Election Defamation Suit
Another Reason Trump Is Running For POTUSNYT: As Legal Fees Mount, Trump Steers Donations Into PAC That Has Covered Them
The Dwindling Non-MAGA GOP Is Getting DesperateFormer federal Appeals Court Judge J. Michael Luttig in the NYT:
If the indictment of Mr. Trump on Espionage Act charges — not to mention his now almost certain indictment for conspiring to obstruct Congress from certifying Mr. Biden as the president on Jan. 6 — fails to shake the Republican Party from its moribund political senses, then it is beyond saving itself. Nor ought it be saved.
Beyond saving?
Anything Happen In Russia Over The Weekend?Amazing how much can come and go between the Friday and Monday iterations of the Morning Memo:
The bizarro GOP flipflop on special elections in Ohio in order to take a whack at abortion rights is causing havoc for beleaguered elections officials.
John Goodenough, 1922-2023A reminiscence of John B. Goodenough by a former profiler of his:
Speaking Of Batteries …The former president went on a misinformation-laden rant against electric vehicles and Biden while on a campaign trip to Michigan:
Driven by his ridiculous regulations, electric cars will kill more than half of U.S. Auto jobs and decimate the suppliers that they decimated already — decimate the suppliers and it's going to decimate your jobs and it's going to decimate more than anybody else, the state of Michigan. … It's is going to be decimation it's going to be at a level that that people can't even imagine.
Fact-free fear-mongering.
Quite A WeekendLike Morning Memo? Let us know!
National Vision Holdings Inc. (EYE) Stock: A Look At The Monthly Trend
In the past week, EYE stock has gone down by -2.58%, with a monthly decline of -6.07% and a quarterly surge of 33.85%. The volatility ratio for the week is 2.50%, and the volatility levels for the last 30 days are 3.08% for National Vision Holdings Inc. The simple moving average for the past 20 days is -5.62% for EYE's stock, with a -23.17% simple moving average for the past 200 days.
Is It Worth Investing in National Vision Holdings Inc. (NASDAQ: EYE) Right Now?The price-to-earnings ratio for National Vision Holdings Inc. (NASDAQ: EYE) is above average at 69.31x. The 36-month beta value for EYE is also noteworthy at 1.39. There are mixed opinions on the stock, with 8 analysts rating it as a "buy," 0 rating it as "overweight," 3 rating it as "hold," and 0 rating it as "sell."
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The average price estimated by analysts for EYE is $28.27, which is $3.97 above than the current price. The public float for EYE is 77.46M, and at present, short sellers hold a 8.86% of that float. The average trading volume of EYE on June 30, 2023 was 1.37M shares.
EYE) stock's latest price updateNational Vision Holdings Inc. (NASDAQ: EYE) has seen a rise in its stock price by 0.50 in relation to its previous close of 24.00. However, the company has experienced a -2.58% decline in its stock price over the last five trading sessions.
EYE Trading at 0.77% from the 50-Day Moving AverageAfter a stumble in the market that brought EYE to its low price for the period of the last 52 weeks, the company was unable to rebound, for now settling with -44.96% of loss for the given period.
Volatility was left at 3.08%, however, over the last 30 days, the volatility rate increased by 2.50%, as shares sank -4.48% for the moving average over the last 20 days. Over the last 50 days, in opposition, the stock is trading +20.24% upper at present.
During the last 5 trading sessions, EYE fell by -2.58%, which changed the moving average for the period of 200-days by -35.37% in comparison to the 20-day moving average, which settled at $25.50. In addition, National Vision Holdings Inc. Saw -37.77% in overturn over a single year, with a tendency to cut further losses.
Insider TradingReports are indicating that there were more than several insider trading activities at EYE starting from PEELER D RANDOLPH, who purchase 17,609 shares at the price of $25.73 back on May 23. After this action, PEELER D RANDOLPH now owns 148,880 shares of National Vision Holdings Inc., valued at $453,080 using the latest closing price.
PEELER D RANDOLPH, the Director of National Vision Holdings Inc., purchase 22,861 shares at $25.59 during a trade that took place back on May 22, which means that PEELER D RANDOLPH is holding 131,271 shares at $585,013 based on the most recent closing price.
Stock Fundamentals for EYECurrent profitability levels for the company are sitting at:
The net margin for National Vision Holdings Inc. Stands at +2.10. The total capital return value is set at 3.20, while invested capital returns managed to touch 2.30. Equity return is now at value 3.40, with 1.30 for asset returns.
Based on National Vision Holdings Inc. (EYE), the company's capital structure generated 111.29 points at debt to equity in total, while total debt to capital is 52.67. Total debt to assets is 41.22, with long-term debt to equity ratio resting at 102.26. Finally, the long-term debt to capital ratio is 48.40.
When we switch over and look at the enterprise to sales, we see a ratio of 1.30, with the company's debt to enterprise value settled at 0.26. The receivables turnover for the company is 29.58 and the total asset turnover is 0.85. The liquidity ratio also appears to be rather interesting for investors as it stands at 1.38.
ConclusionIn summary, National Vision Holdings Inc. (EYE) has had a bad performance as of late. Analysts have bullish opinions on the stock, with some viewing it as a "buy" and others as a "hold". It's important to note that the stock is currently trading at a significant distance from its 50-day moving average and its 52-week high.
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