|Posted on April 11, 2021 at 11:05 PM|
|Posted on March 17, 2021 at 7:25 PM|
Patients suffering from dry eye disease symptoms have a lower quality of life compared to those without symptoms, a new study reports. The findings showed that patients with the condition reported negative effects on visual function, their ability to carry out daily activities and their work productivity.
Dry eye disease is a common condition and a frequent reason for patients to seek medical care. It can affect people of any age but is most prevalent in women and in older people. Symptoms include irritation and redness in the eyes, blurred vision, and a sensation of grittiness or a foreign body in the eye. It has been reported that up to a third of adults over 65 years old have the condition, although the actual number is likely to be higher as there is no established diagnostic test and people with mild symptoms are less likely to report them to their doctor.
Treatment often involves prescriptions of artificial tears, ocular lubricants and astringents, which come at a cost to the NHS; in 2014, 6.4 million items were prescribed at a cost of over £27 million.
This new study, led by the University of Southampton, set out to explore how dry eye disease affects the lives of adults in the UK through an online survey of one thousand patients with the condition and further one thousand without. Participants undertook a questionnaire from the National Eye Institute about their visual function and a EuroQol questionnaire on health-related quality of life. Those who declared that they experienced dry eye disease also answered further questions to assess the severity of their symptoms.
The results, published in the journal BMJ Open, showed that a higher proportion of participants with dry eye disease had problems with mobility and experienced more difficulties in their day-to-day activities than patients without the condition. The surveys also revealed they were more likely to suffer from anxiety and depression.
Those with the most severe symptoms we more likely to experience a negative impact on their social and emotional functioning as well work productivity, including missing more time from work as a result of their symptoms.
Dr Parwez Hossain, Associate Professor in Ophthalmology at the University of Southampton, led the study. He said: "This study provided some very useful information on the burden that dry eye disease places on patients. As well as confirming the impact on work and social lives we also discovered showed that the extent of the effects are consistent with the severity of symptoms. We also found that participants with dry eye disease symptoms were a lot more likely to suffer from other comorbidities, twice as many suffered from arthritis, hearing loss or irritable bowel disease compared to the cohort without symptoms.
"Whilst we cannot draw causal associations through this study, the presence of dry eye disease does appear to impact on an individual's health and vision related quality of life."
Although both groups reported similar levels of digital screen use and reading, the cohort with symptoms reported more exposure to environmental factors such as air conditioning, forced heating or air pollution. The research team believe that these factors could either contribute to dry eye disease, or be noticed more by sufferers.
Reference: Hossain P, Siffel C, Joseph C, et al. Patient-reported burden of dry eye disease in the UK: a cross-sectional web-based survey. BMJ Open. 2021;11(3):e039209. doi: 10.1136/bmjopen-2020-039209
|Posted on March 17, 2021 at 7:20 PM|
Whether they are tears of pain or tears of joy, the truth about tears is that these tiny, salty droplets are essential for the nutrition, lubrication, and protection of our eyes.
But the precise biological mechanism behind how tears accomplish these feats was hazy. Part of the problem is there are few good ways to study crying in the lab, but a new study might offer a pathway to greater clarity. In a new paper published this week in the journal Cell Stem Cell, scientists describe how they grew cultured cell analogs of human tear glands in the lab, known as organoids, and, perhaps more incredibly, how they managed to make these tear glands cry.
WHY IT MATTERS — Aside from the visual poetry of having artificial lacrimal glands bawling away in a petri dish in a lab, the fact is this may represent a watershed moment in treating dry-eye disease.
Hans Clevers is group leader at the Hubrecht Institute for Developmental Biology and Stem Cell Research in the Netherlands and lead author on the new study. He tells Inverse that the organoids open new avenues for treatment previously denied people who experience chronic dry eyes. An estimated 5 percent of the population experience dry eyes.
“The biggest promise is the fact that we are now in a position to start thinking about treatment of dry eyes with cells,” Clevers tells Inverse.
“And I guess the nicest takeaway for the non-scientists is the fact that you can actually grow tear glands in a dish and make them cry,” he adds.
The lab-grown organoids, which are essentially a collection of human stem cells cultured in a dish and coaxed into taking on certain traits analogous with actual human cells, could potentially parlay into a totally new treatment themselves. Essentially, it may be possible to one day transplant organoid-based replacement glands into a human eye: something the research community has been working towards for years.
|Posted on March 17, 2021 at 7:15 PM|
The pipeline for dry eye disease drugs is beginning to heat up, with two biotechs announcing key developments, aiming to disrupt a market led by Allergan and Novartis.
Novartis paid Takeda $3.4 billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche.
But with Novartis failing to convince European regulators about the merits of Xiidra last year, and Allergan’s ageing Restasis potentially facing generic competition, there’s a lot to play for and two biotechs are aiming to disrupt the market.
Sylentis, part of PharmaMar Group, has just announced FDA approval of a phase 3 trial for eye drops containing tivanisiran, in dry eye disease associated with Sjogren’s Syndrome.
The study design, involving more than 30 hospitals in the United States and 200 patients, has been approved by the FDA in 30 days and will be part of the marketing authorisation application, which will include another phase 3 trial.
Goals of the placebo-controlled study include efficacy (signs and symptoms) and safety of tivanisiran in patients with dry eye disease, associated with Sjögren’s Syndrome.
Tivanisiran is based on gene silencing technology using RNA interference (RNAi) and selectively inhibits production of the transient receptor potential cation channel (TRPV1).
The design of the protocol for the trial and its authorization are based on the scientific evidence of safety and efficacy obtained in the phase 3 HELIX trial.
This study showed a significant improvement in signs and symptoms in the subgroup of patients with Sjögren’s syndrome, which is a more severe form of dry eye disease.
Azura’s dry eye drug on target in phase 2
In a separate development, Israel-based Azura Ophthalmics said its potential dry eye drug AZR-MD-001 hit its target in a phase 2 trial, paving the way for further development.
AZR-MD-001, met its primary endpoints of showing improvements in both the signs and symptoms of dry eye disease caused by Meibomian gland dysfunction (MGD) reaching statistical significance compared to control in the two highest doses tested.
Around 86% of people with dry eye disease show symptoms of Meibomian gland dysfunction, where the glands that line the eyelids become blocked, preventing them from secreting enough oil into the tear film needed to properly lubricate the eye.
The company pointed out that current treatment options mainly focus on treating inflammation, which accounts for a “minority” of the dry eye disease population.
In an emailed interview, CEO Marc Gleeson, said results justify phase 3 development of AZR-MD-001.
He told pharmaphorum: “Given that there are 30 million patients in the US already diagnosed with dry eye disease – of which MGD is the root cause – with the majority not currently on a prescription treatment, this is a large market with high unmet need.
“Based on the topline results of our integrated analyses, AZR-MD-001 has the potential to be a first-in-class treatment option for patients with mild-to-moderate MGD. AZR-MD-001 is well-differentiated from other treatment options for MGD in a number of ways, including its formulation, mechanism of action and mode of delivery.”
Azura said it plans to announce results of its first registration study in the first half of 2022, with a $20 million funding round announced in October providing the financial backing.
Further fundraising will be needed to support a filing, Gleeson said and any additional funds will also be used to advance the company’s pipeline of novel ophthalmic drugs.
Gleeson added: “With that said, we are open to all options, including evaluating partnerships that will help bring this medicine to those suffering from the debilitating symptoms of MGD.”