Eye care is advancing at a rapid pace, and the Ophthalmology Times® EyeCon 2022 is the best place to discover opportunities in the field to bring home to your practice. 

Ophthalmology EyeCon 2022

Palatin Technologies Inc. today announced the results of a planned interim analysis of the Phase 3 pivotal study of PL9643 (MELODY-1) in patients with dry eye disease (DED).

According to the company, the interim analysis included an assessment and review by the independent Data Monitoring Committee (DMC) of the efficacy and safety of the first 120 patients who had completed treatment. Based on their review, the DMC recommended the study continue with a study sample size target of up to 350 patients. No safety concerns were identified by the DMC.

The company noted in its news release that the DMC's primary objective was to provide a recommendation on the final sample size based on an interim assessment using a conditional power modeling approach. The DMC had the option to recommend a final sample size of up to 600 patients.

According to the news release, the DMC performed its assessment on the first 120 patients to complete the study and based on their recommendation, Palatin plans to enroll up to an additional 230 patients in the study for a final sample size of 350 patients. Topline results are expected in the second quarter of calendar 2023.

Carl Spana, PhD, president and CEO of Palatin, pointed out that the company was encouraged by the DMC's recommendation to continue enrolling patients in this ongoing trial.

“The emerging data, including the safety and ocular tolerability, indicate that PL9643 could be a potentially safe and effective treatment for patients with DED," Spana said in the news release. “Based on trial results to date, we believe PL9643, with its differentiating factors, could provide a fast-acting and well-tolerated treatment option for the millions of patients suffering from DED, and we look forward to presenting topline results of this Phase 3 trial in the second quarter of calendar 2023."

The pivotal Phase 3 MELODY-1 clinical study is a multi-center, randomly assigned, double–masked and vehicle–controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in patients with moderate-to-severe DED.

According to the news release, the study design is based on positive Phase 2 results of PL9643 for the treatment of DED, and an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), reaching agreement on all key elements of a pivotal Phase 3 clinical program.

Dry eye disease is estimated to affect over 20 million people in the United States. Existing therapy for DED is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity.

According to the news release, Palatin Technologies focuses on developing medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems.

The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function.

The company noted that there are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.

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An independent data monitoring committee recommends continuing study with a sample size target of up to 350 Patients. According to the company, no safety concerns have been identified and topline results are expected during the second quarter of 2023. 

Palatin reports positive interim analysis in Phase 3 pivotal study of potential therapeutic for patients with dry eye disease

In a study that examined the prescribing patterns among thousands of American ophthalmologists and optometrists, a team of researchers from Johns Hopkins Medicine concluded that eye doctors who receive even small financial incentives from pharmaceutical companies, such as free food, sponsored travel to attend meetings or consulting fees, are up to twice as likely to prescribe the companies’ brand name eyedrops for glaucoma instead of cheaper generic versions.

According to Thomas Johnson III, MD, PhD, the Allan and Shelley Holt Rising Professor in Ophthalmology at the Johns Hopkins University School of Medicine and Wilmer Eye Institute, researchers could not determine why some clinicians more frequently prescribe high cost branded eyedrops when generics are generally just as good. He pointed out that the study was not designed to find an answer to that question.

“Perhaps frequent exposure to positive messaging about a drug influences this tendency, or prescribers feel compelled, consciously or subconsciously, to demonstrate their collegiality with pharmaceutical sales representatives,” he said in a Johns Hopkins Medicine new release.

According to Johns Hopkins, other studies have shown that pharmaceutical company contributions — large and small —influence a range of treatment decisions, including choices of eye injections for macular degeneration, an age-related eye disease.

Moreover, Johns Hopkins noted that the study, published in 

 focused on glaucoma eyedrops widely prescribed to reduce eye pressure and fluid buildup and to halt worsening of the blinding eye disease.

Johns Hopkins also noted that more than 3 million Americans have the disorder, according to the United States Center for Disease Control and Prevention. The drops are available in both generic and brand name versions and have similar side effects. The generic versions are about half the cost of the branded ones and are equally effective, say the researchers.

Researchers designed the study to examine the link between receiving financial incentives from pharmaceutical companies and practitioners’ choices to prescribe branded versus generic glaucoma drops. The average annual amount paid to recipients in the study group in 2018 was $65 (range: $24 to $147).

According to the news release, as part of the study the research team reviewed payment claims from the Centers for Medicare and Medicaid Services to find 26,038 vision care professionals who prescribed glaucoma eyedrops in 2018. The group included 7,449 female and 18,589 male vision care practitioners. Some 5,426 were optometrists and 20,612 were ophthalmologists, including 1,103 glaucoma specialists.

Most of the group (21,438) practiced in urban locations.

On average, practitioners prescribed 1,778 days’ worth of glaucoma eyedrops during the study period. Some 16,353 prescribers (63%) did not receive payments from the makers of branded eyedrops.

The researchers, according to the news release, also found that during the study period, drug makers spent $5,060,346 on payments to the practitioners who were part of the study, and 92% of these funds were spent on only 25% of participants.

Among the group studied, 4,559 did not prescribe a branded eyedrop. Some 17,480 practitioners did prescribe branded eyedrops, but less than half of the time. Another 3,999 practitioners prescribed branded eyedrops more than half the time.

After further statistical analysis, the researchers concluded that practitioners receiving any amount of pharmaceutical company payment were 1.8 times more likely than practitioners receiving no payments to prescribe branded eyedrops more than half of the time.

Prescribers who received more payments — in the top 25% of recipients — had a two-fold greater likelihood of prescribing branded eyedrops than practitioners receiving no payments.

The link between payments and prescribing of branded drops stood firm, the researchers say, even when excluding the top 5% and 1% of practitioners receiving payments. This suggests that the link is not driven by a few “outlier” prescribers who received the most payments, say the researchers.

The prescribers’ gender, urban location and glaucoma specialty status were not associated with higher frequency of branded eyedrop prescriptions.

"While some vision care professionals may say that small payments will not influence their prescribing behavior, these data suggest otherwise,” according to study co-author Gerard Anderson, PhD, a professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health.

Funding for the research was provided by the Johns Hopkins University School of Medicine, the National Institutes of Health’s National Eye Institute (K08EY031801), the Wilmer Eye Institute at Johns Hopkins, the Allan and Shelley Holt Rising Professorship and Arnold Ventures.

Andrew Nguyen from Johns Hopkins and Kelly Anderson from the University of Colorado contributed to the statistical analysis and writing of this research.

Johnson has received nonfinancial support from Icare USA and grants from Perfuse Therapeutics and Injectsense.

1 Andrew M. Nguyen, BS, BA; Kelly E. Anderson, PhD, MPP; Gerard Anderson, PhD; et.al; Association Between Open Payments-Reported Industry Transfers of Value and Prostaglandin Analog Prescribing in the US. 

. Published July 28, 2022. doi:10.1001/jamaophthalmol.2022.2757

According to Johns Hopkins Medicine researchers, as little as $65 per year appears to influence practitioners, making them up to twice as likely to prescribe the companies’ brand name eyedrops for glaucoma instead of cheaper generic versions.



Study: Eye doctors receiving even small payments from drug companies more likely to prescribe name-brand eyedrops

Cornea implant made of collagen protein from pig’s skin. (

A team of researchers at Linköping University (LiU) has restored the vision of 20 volunteers in a pilot study that used a cornea implant made out of collagen gathered from pig skin. Pending further testing, the novel bioengineered implant may help ophthalmologists improve the vision of millions of patients around the world awaiting difficult and costly cornea transplant surgeries.

Researchers and entrepreneurs have developed an implant made of collagen protein from pig’s skin, which resembles the human cornea. In a pilot study, the implant restored vision to 20 people with diseased corneas, most of whom were blind prior to receiving the implant.

 jointly led by researchers at LiU and LinkoCare Life Sciences AB has been published in 

. The promising results bring hope to those suffering from corneal blindness and low vision by providing a bioengineered implant as an alternative to the transplantation of donated human corneas, which are scarce in countries where the need for them is greatest.

“The results show that it is possible to develop a biomaterial that meets all the criteria for being used as human implants, which can be mass-produced and stored up to two years and thereby reach even more people with vision problems,” said Neil S. Lagali, a professor at the Department of Biomedical and Clinical Sciences at LiU, one of the researchers behind the study. “This gets us around the problem of shortage of donated corneal tissue and access to other treatments for eye diseases.”

According to a news release from Linköping University, an estimated 12.7 million people around the world are blind due to their corneas, which is the outermost transparent layer of the eye, being damaged or diseased. A corneal transplant may be the only way for these patients to regain vision, and that requires a human donor. The university noted that just 1 in 70 patients receives a cornea transplant. Furthermore, most of those who need cornea transplants live in low and middle-income countries in which access to treatments is very limited.

The researchers have developed a new, minimally invasive method. A small incision is made, through which the implant is inserted into the existing cornea. The incision can be made with an advanced laser (as in the photo), but also, when needed, by hand with simple surgical instruments. (Image courtesy of Thor Balkhed/Linköping University)

“Safety and effectiveness of the bioengineered implants have been the core of our work, said Mehrdad Rafat, the researcher and entrepreneur behind the design and development of the implants. He is an adjunct associate professor (senior lecturer) at LiU’s Department of Biomedical Engineering and founder and CEO of the company LinkoCare Life Sciences AB, which manufactures the bioengineered corneas used in the study.

“We have made significant efforts to ensure that our invention will be widely available and affordable by all and not just by the wealthy,” he explained. “That is why this technology can be used in all parts of the world.”

The cornea consists mainly of the protein collagen. To create an alternative to human cornea, the university noted that the researchers used collagen molecules derived from pig skin that were highly purified and produced under strict conditions for human use. The pig skin used is a byproduct of the food industry, making it easy to access and economically advantageous. In the process of constructing the implant, the researchers stabilized the loose collagen molecules forming a robust and transparent material that could withstand handling and implantation in the eye. While donated corneas must be used within two weeks, the bioengineered corneas can be stored for up to two years before use.

The university also noted that the researchers have developed a new, minimally invasive method for treating the disease keratoconus, in which the cornea becomes so thin that it can lead to blindness. Today, a keratoconus patient’s cornea at advanced stage is surgically removed and replaced by a donated cornea, which is sewn into place using surgical sutures. This kind of surgery is invasive and only done at larger university hospitals.

Lagali noted in the news release that a less invasive method could be used in more hospitals, thereby helping more people.

“With our method, the surgeon doesn’t need to remove the patient’s own tissue,” he explained. “Instead, a small incision is made, through which the implant is inserted into the existing cornea.”,

Lagali, according to the university, has led the research group that has developed this surgical method.

Moreover, the university noted that no stitches are needed with this new surgical method. The incision in the cornea can be made with high precision thanks to an advanced laser, but also, when needed, by hand with simple surgical instruments. The method was first tested on pigs and turned out to be simpler and potentially safer than a conventional cornea transplant.

The surgical method and the implants were used by surgeons in Iran and India, two countries where many people suffer from corneal blindness and low vision, but where there is a significant lack of donated corneas and treatment options.

According to the university’s news release, 20 people who were either blind or on the verge of losing sight due to advanced keratoconus participated in the pilot clinical study and received the biomaterial implant. The operations were free from complications; the tissue healed fast; and an 8-week treatment with immunosuppressive eye drops was enough to prevent rejection of the implant. With conventional cornea transplants, medicine must be taken for several years. The patients were followed for 2 years, and no complications were noted during that time.

The primary purpose of the pilot clinical study was to investigate whether the implant was safe to use. However, the researchers were surprised by what happened with the implant. The cornea’s thickness and curvature were restored to normal. At the group level, the participants’ sight improved as much as it would have after a cornea transplant with donated tissue. Before the operation, 14 of the 20 participants were blind. After two years, none of them was blind any more. Three of the Indian participants who had been blind prior to the study had perfect (20/20) vision after the operation.

A larger clinical study followed by market approval by regulatory authorities is needed before the implant can be used in healthcare. The researchers also want to study whether the technology can be used to treat more eye diseases, and whether the implant can be adapted to the individual for even greater efficacy.

LinkoCare Life Sciences AB, which is responsible for the production, certification, packaging, and sterilisation of the implants used in the study, with the support of Care Group India, covered the cost of implant manufacturing, ISO-compliant preclinical testing, and clinical testing.

Further funding for the study for biomaterials and surgical development and testing came from the European Union Horizon 2020 Program, and ALF funds from Linköping University and the Östergötland Region. These funders did not participate in the design or execution of the research. Mehrdad Rafat is the patent holder, via LinkoCare AB, and sits on the company’s board. Another of the study's co-authors (Shideh Tabe) also sits on the company’s board.

Lagali has no financial disclosures related to this content.

1. Mehrad Rafat; Mahmoud Jabbarva; Namrate Sharma; Maria Xeroudaki; Shideh Tabe; Raha Omrani; Muthukumar Thangavelu; Anthony Mukwaya; Per Fagerholm; Anton Lennikov; Farshad Askarizadeh; Neil Lagali; Bioengineered corneal tissue for minimally invasive vision restoration in advanced keratoconus in two clinical cohorts. 

; published Aug. 11, 2020; accessed Aug. 13, 2020. DOI: 10.1038/s41587-022-01408-w

Researchers at Linköping University have used implants made from pig skin to restore sight to 20 people with diseased corneas.  

Bioengineered cornea can restore sight to the blind and visually impaired

Assessing the severity of multiple sclerosis (MS) is key as physicians seek a course of treatment for patients diagnosed with this disease, but it can prove to be challenging with existing methods.

A study by a team at the Medical University of Vienna is highlighting how the retina can be used as a prognostic marker. Analyses revealed that retinal layer thinning as a result of an MS relapse predicts the severity of future relapses and, hence, the likelihood of disability. The results of the study have now been published in 

A team of esearchers led by Gabriel Bsteh and Thomas Berger from the Department of Neurology at MedUni Vienna/University Hospital Vienna, working in collaboration with the Department of Ophthalmology and Optometrics at MedUni Vienna/University Hospital Vienna, studied 167 MS patients over a period of more than 3 years.

According to the university, the team hypothesized that retinal damage due to relapse reflects the extent of damage in the brain. As the scientific analyses confirmed, the loss of approximately 5 µm of retinal layer thickness after optic neuritis equates to a doubling of the risk of permanent disability after the next relapse. These predictions could be used as the basis for treatment decisions in future: the results of the study suggest that more aggressive treatment is indicated where there is significant retinal layer thinning than would be the case for a smaller degree of thinning. This is true even if the patient has no disability or only slight disability at the time of measurement.


The researchers used optical coherence tomography (OCT) to measure retinal layer thickness. OCT is an imaging technique that uses infrared light to produce high-resolution three-dimensional images of very thin layers of tissue in the micrometre range (1 micrometre=1 thousandth of a millimetre). It is already used as a tool for diagnosing eye diseases such as glaucoma, and for evaluating disease progression.

"The technique for predicting the course of MS is therefore already available to us," said Bsteh, first author of the study. "As we discovered in the course of our clinical trial, measurements should be taken at initial diagnosis, directly when optic neuritis occurs in relapsing MS, and 6 months thereafter."


Multiple sclerosis is a chronic inflammatory autoimmune disease that leads to the loss of axons and neurons throughout the entire nervous system. Although this damage often goes unnoticed by patients at first, its extent determines the prognosis for the severity of the disease. Since predictions about the course of the disease are important in MS for selecting the appropriate treatment, medical research has long been searching for reliable prognostic tools.

"In retinal layer thickness, we have found a new biomarker that represents a window to the brain, as it were," Bsteh added, summarizing the essence of the study. If the results are confirmed in larger follow-up studies, the technique could also be applied in routine clinical practice.

Gabriel Bsteh, Nik Krajnc, Katharina Riedl, Patrick Altmann, Barbara Kornek, Fritz Leutmezer, Stefan Macher, Christoph Mitsch, Philip Pruckner, Paulus Rommer, Gudrun Zulehner, Berthold Pemp, Thomas Berger; Retinal layer thinning after optic neuritis as a predictor of future relapse remission in relapsing multiple sclerosis. 

, Published July 2022. doi: 10.1212/WNL.0000000000200970

Researchers at the Medical University of Vienna are focusing on how the retina can be used as a prognostic marker. Analyses revealed that retinal layer thinning as a result of an MS relapse predicts the severity of future relapses and the likelihood of disability.

Retina may provide clues to the severity of multiple sclerosis 

A Connecticut doctor pleaded guilty today in federal court in Boston to receiving kickbacks in exchange for ordering medically unnecessary brain scans.

According to a news release from the U.S. Attorney’s Office for the District of Massachusetts, Donald Salzberg, MD, 67, of Avon, Conn., pleaded guilty before U.S. Senior District Court Judge Douglas P. Woodlock to one count of conspiracy to commit health care fraud and one count of conspiracy to receive kickbacks.

The court has yet to set a date for a sentencing hearing. Salzberg was charged by an Information on May 23.

Salzberg, who for 36 years has been a licensed ophthalmologist in Connecticut, owned and operated Donald J. Salzberg, MD, an ophthalmology practice in West Hartford, Conn.

According to federal authorities, from 2014 through 2019, Salzberg conspired with a principal for a medical diagnostics company that performed transcranial doppler (TCD) scans – brain scans that measure blood flow in parts of the brain – to order hundreds of medically unnecessary TCD scans in exchange for kickbacks.

Salzberg, whose practice is in West Hartford, Conn., used false patient diagnoses to order the brain scans and the other person would submit claims to Medicare and other insurance companies for payment, prosecutors said.

Salzberg was paid cash kickbacks of $100 to $125 for each test that he ordered, as well as sham administrative services fees. More than $3 million in fraudulent claims were submitted to Medicare and private insurance companies, according to federal authorities.

The U.S. attorney’s office in Boston noted that charge of conspiracy to commit health care fraud provides for a sentence of up to 10 years in prison, three years of supervised release and a fine of up to $250,000. The charge of conspiracy to violate the anti-kickback statute provides for a sentence of up to five years in prison, three years of supervised release and a fine of up to $250,000.

Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and statutes which govern the determination of a sentence in a criminal case.

Assistant U.S. Attorneys Rachel Y. Hemani and Howard Locker of Rollins’ Health Care Fraud Unit are prosecuting the case.

Donald Salzberg, MD, conspired with an alleged accomplice at a medical diagnostic company in a scheme that ran for five years, from 2014 through 2019, according to U.S. attorney’s office in Boston.

Connecticut ophthalmologist pleads guilty in health care fraud scheme

 Biosimilars have been around for a few years in medicine, but then again, they are new to us. Are you concerned about knowledge gaps? Are you concerned about the retina specialists not understanding what a biosimilar is and how it’s tested? Any concerns?

 Until I started delving into this and understanding how biosimilars are made, what the safety standards are, and what equivalence studies are done, I was skeptical myself. Having read and understood the SB11 results, the FYB201, and then the design of all these other biosimilars for ranibizumab and aflibercept, I feel much more comfortable. I look at the equivalence studies, and I see that the curves are sitting right on top of each other in terms of visual acuity improvement and OCT decrease. Even when you look at the secondary end points, they’re hitting right on the mark. That tells me I am comfortable with the equivalence. The second part is the safety, so we look at the SB11, we look at the FYB201, and we see that they carried out the safety beyond what was required by the FDA. So we have 1-year safety data. On top of that, the FDA is requiring careful reporting and adherence to the standards. And [we’re] also looking carefully at the AEs [adverse effects], comparing the biosimilar AEs that are coming out to what’s happening with the reference standard, so that if there is a signal, we’re going to see it. I think retina specialists need to understand that, and I think we need to read about it. We need to educate our peers so that we feel comfortable using this. The flip side is the patient. The patient must understand that this is not necessarily a generic, because sometimes generics have connotations that they might not be quite as good. We can tell them that these are biosimilar drugs that have the same potency, efficacy, and safety, and [they] underwent rigorous testing.

 To be honest, I had to do a little homework for this event, because I, too, had those knowledge gaps. I didn’t precisely know the developmental path. I’ve been doing clinical investigations for trials of these reference products we’ve been using through the years, so I’m very familiar with the traditional biologic process. Some of the biologics that have been introduced have had unexpected intraocular inflammation problems. There is some concern, or a general heightened awareness, [that] the eye is a sensitive organ, and inflammation can be disastrous. Not always, but it can be. We saw that with an FDA-approved product. Any biologic that’s new to us in retina, people are going to be cautious at first and be scrutinizing not only the clinical trials, but also that postmarketing surveillance.

 Exactly. That’s why it’s going to be key how we frame this. How do we present it to our patients? We must present it in a positive light because there’s this nocebo effect. We always talk about the placebo, but we don’t really talk about the nocebo effect.

 The nocebo effect is, if you think something is not going to work as well, you will have this negative effect. Technically, you can get this. So how would this work with a biosimilar? Somebody could think, "the biosimilar may not work as well," and any side effect they have, they’ll attribute it to the biosimilar. That could be on the physician side, or it can be on the patient side. We must be careful that when we report these effects out, and when we present these to our patients, we’re cognizant of that. Again, positive framing, and explaining to the patient that this is an equivalent drug. That’s not to say I’m not going to be open to the fact that they do have a side effect, or if we see IOI [intraocular inflammation], of course we’re going to be on the lookout for that, but in general, realize that you have to be open-minded about this and give it a fair shot.

Videos

Carl D. Regillo, MD, and Jennifer I. Lim, MD, discuss how evolving understanding regarding bioequivalence and the safety of biosimilars may lead to their wider use in the treatment of retinal disorders.

Bridging Knowledge Gaps Regarding Biosimilars in the Treatment of Retinal Disorders

 One of the interesting things that people may not know about biologics, both reference on-label drugs that we’ve been using and now the biosimilars coming, is that they can evolve over time because it’s from a living cell process. The ranibizumab or the aflibercept that we tested in clinical trials back 10, 12 years ago is not necessarily identical to what we’re using now, because these processes change. And they, too, need to live up to that postmarketing standard, so the process is pretty much the same. I think we should be reassured, and hopefully we will be, that these products¼they’re the same in purity, efficacy, and safety.

 It’s very important. In fact, we saw this happen in India with their ranibizumab biosimilar. When they looked at it, they were seeing IOI. What they had to do was go back to the living cell processes, and they were able to clean it up to decrease the IOI.

 Intraocular inflammation. We know that because living cells are living, each batch is not the same. That’s where the purity and the standards come in, and that’s where the FDA is looking closely at these biosimilars so that we can be confident using these drugs.

 My understanding is [that] we have a good system in place to be able to monitor for these things. Even with the products we’ve been using, there were some inflammatory events; even with reference products these things can happen. Hopefully, they’re not going to happen any more than they have with our products we’ve been using.

So biosimilars, that’s new to us in the field of retina, with our first one now FDA approved and in the process of being launched, but it’s not new to medicine.

 Absolutely. We see this in oncology, and we saw it in rheumatology, that when the biosimilars came out, within two years of their introduction, the adoption by the physicians and the patients went almost exponentially. It took a bit of time for people to feel comfortable with it, and then to realize that it worked just as well in terms of efficacy and safety, so that now a vast proportion of the Medicare Part D that’s spent for these biologics is on biosimilars.

Carl D. Regillo, MD, and Jennifer I. Lim, MD, share historical perspective on the safety of biosimilars and their use in medicine.

Purity and Safety Standards for Biosimilars

Oyster Point Pharma Inc. today announced that the largest Medicare pharmacy benefit manager in the United States will add its varenicline solution nasal spray (Tyrvaya) for the treatment of dry eye on its Medicare Part D formularies, effective September 1.

According to Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point Pharma, the milestone will further expand patient access and enable continued momentum in eye care professionals prescribing the nasal spreay for the treatment of dry eye disease.

“In the United States, almost half of the total dry eye disease prescriptions are covered by Medicare, and we believe TYRVAYA provides a truly compelling treatment option,” he said in a statement. “We are committed to growing patient access and are looking forward to continue engaging with Medicare Part D health plans.”

The FDA in Ooctober 2021 approved the varenicline solution nasal spray for the treatment of the signs and symptoms of dry eye disease.

According to the company, varenicline solution nasal spray 0.03 mg is a selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system, the "rest and digest" system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose.

The company noted that the efficacy of the spray in dry eye disease is believed to be the result of varenicline's activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors. The exact mechanism of action is unknown at this time.

Oyster Point Pharma announces varenicline solution nasal spray for treatment of dry eye to be covered by key Medicare pharmacy benefit manager

A team of investigators has found that myopic refractive error is linked with an increased risk of primary open-angle glaucoma (POAG), and they content the connection has a genetic foundation.

The study, published in JAMA Ophthalmology,

 found that it is imperative to identify any factors that could impact a patient’s POAG risk, and those can include pre-existing genetic risks.

As part of their study of genetic links, the investigators conducted their research using methods that rely upon variation in genes with known functions to study causal effects of a modifiable exposure on an outcome. They noted that the study was a 2-sample Mendelian randomly assigned study evaluating the shared genetic influences, and investigating the link of myopic refractive error and POAG.

According to the study, investigators included 154,018 participants from the UK Biobank and Genetic Epidemiology Research on Adult Health and Aging (GERA) cohort.

Investigators also noted that the observational analyses included data for 54,755 non-Hispanic white individuals (31,926 females and 22,829 males), among which were 4,047 POAG patients and 50,708 controls. According to the investigators, POAG patients had a lower refractive mean spherical equivalent and had an increased likelihood to have myopia or high myopia vs. controls (myopia: 40.2% vs. 34.1%; high myopia: 8.5% vs. 6.8%).

Moreover, the investigators pointed out in the study that the genetic correlation analysis found that POAG was genetically correlated with mean spherical equivalent refractive error, myopia and high myopia. They also indicated that genetically assessed refractive mean spherical equivalent typically was negatively linked with a risk of POAG.

The investigators further noted in the paper that the results support the use of refractive error as a metric to help determine the risk of POAG in the general population.

“Currently, general population screening for glaucoma is not recommended in part due to the relatively low prevalence of undetected cases,” the investigators wrote in the paper. “Understanding which factors increase risk of POAG can help inform strategies for identifying glaucoma-enriched populations for targeted screening, which would lead to earlier diagnosis and preventative strategies for high-risk individuals.

Moreover, the investigators noted that the results also can assist in the clarification of the links between myopic refractive effort and POAG, leading to basing the identification of future POAG risk on refractive error information, which could ultimately lead to earlier diagnosis and preventative strategies for high-risk individuals.

“Clarifying the nature of the association between refractive error and POAG may open new avenues of investigation into specific mechanisms underlying these vision disorders,” investigators concluded.

1. Choquet H, Khawaja AP, Jiang C, et al. Association between myopic refractive error and primary open-angle glaucoma: a 2-sample Mendelian randomization study. 

. Published online July 28, 2022. doi: 10.1001/jamaophthalmol.2022.2762

A team of investigators has found that myopic refractive error is linked with an increased risk of primary open-angle glaucoma, and they indicate that the connection has a genetic foundation. 

Investigators find link between myopia, POAG risk

Sight Sciences Inc. today announced 36-month post-surgery follow-up results of its surgical system (Omni). The data demonstrates that the OMNI Surgical System delivers safe, consistent, and durable results in adult patients with open-angle glaucoma (OAG) on a standalone basis.

According to the company, the study showed that canaloplasty followed by trabeculotomy using the surgical system achieved a mean reduction in intraocular pressure (IOP) of at least 20 percent for all 26 patients (38 eyes) at 36 months follow-up. At 12, 24 and 36 months after surgery, patients’ mean preoperative IOP post medication washout decreased from 24.6±3.2 mmHg to 14.5±1.7 mmHg, 14.2±2.0 mmHg and 15.0±1.9, respectively. The mean number of IOP-lowering medications was reduced from 1.9±0.7 to 0.4±0.6, 0.6±0.7 and 0.5±0.7 at 12, 24 and 36-months.

The postoperative IOP and medication use reduction at 12 months remained consistent over three years, suggesting robust durable effectiveness of the surgical system when used as a standalone intervention either in phakic or pseudophakic eyes. Only a minimal number of adverse events were reported, all of which resolved without any intervention except one eye required secondary IOP lowering intervention.

“As we continue to evaluate this patient group with the OMNI Surgical System, the results consistently show the minimally invasive procedure has the potential to offer long-standing benefits for patients with open-angle glaucoma,” said Karsten Klabe, MD, Principal Investigator, head surgeon of Breyer, Kaymak & Klabe Augenchirurgie. “Most patients experienced an IOP reduction of at least 20 percent and required significantly less medication, meeting the study's objective. By effectively reducing IOP and the medication burden, the OMNI Surgical System is transforming how glaucoma is cared for in both combination cataract and standalone glaucoma patients.”

The company noted in its news release that the clinical observation included 38 eyes from 26 patients with OAG treated with the surgical system. Follow-up visits were done on day 1, week 1 and months 1, 3, 6, 12, 18, 24, 30 and 36 after surgery. This trial is an extension of 24-month data that was published in 

Paul Badawi, co-founder and CEO of Sight Sciences, noted in the news release that the company’s surgical system is supported by a robust clinical development program, which includes this treatment evaluation over 3 years in patients with open-angle glaucoma.

“These results highlight the long-term effectiveness and strong safety profile of the OMNI Surgical System,” Badawi explained in the release. “This non-implantable procedure has shown effectiveness without the known IOP-lowering assistance of cataract surgery. We look forward to ongoing data collection and evaluating the durability at further intervals post-microinvasive canal surgery with OMNI.”

The data results were presented in June at the 15th European Glaucoma Society (EGS) Congress in Athens, Greece.


1. Klabe K, Kaymak H. Standalone Trabeculotomy and Viscodilation of Schlemm’s Canal and Collector Channels in Open-Angle Glaucoma Using the OMNI Surgical System: 24-Month Outcomes. Published July 2021: 3121-3129. 

According to the company, a study shows the non-implantable minimally invasive glaucoma surgery effectively reduces IOP and reduces need for IOP-lowering medications in patients diagnosed with open-angle glaucoma.

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