FDA approves Yutiq for chronic non-infectious uveitis

Yutiq, a non-bio-erodible intravitreal micro-insert containing 0.18 mg fluocinolone acetonide, received FDA approval for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Khanna Institute Of Lasik
Khanna Institute Of Lasik

The FDA received clinical data from two randomized, sham injection-controlled, double-masked phase 3 clinical trials of Yutiq with patient follow-up of 3 years. Both trials achieved the primary efficacy endpoint of prevention of recurrent uveitis flares after 6 months and 12 months, according to the release.

The first trial met its primary efficacy endpoint at 6 months with statistical significance (P < .01), as 18.4% of patients treated with Yutiq experienced uveitis recurrence compared with 78.6% of control patients. In the second trial, 21.8% of patients treated with Yutiq experienced uveitis recurrence at 6 months compared with 53.8% of control patients (P < .01), the release said. The efficacy in both studies was carried out to 12 months.

The 24- and 36-month follow-up data from the first phase 3 trial are expected to be released by the end of this year and the first half of 2019, respectively, according to the company.

Uveitis

Overview

Uveitis is a form of eye inflammation. It affects the middle layer of tissue in the eye wall (uvea).

Uveitis (u-vee-I-tis) warning signs often come on suddenly and get worse quickly. They include eye redness, pain and blurred vision. The condition can affect one or both eyes. It primarily affects people ages 20 to 50, but it may also affect children.

Possible causes of uveitis are infection, injury, or an autoimmune or inflammatory disease. Many times, a cause can’t be identified.

Uveitis can be serious, leading to permanent vision loss. Early diagnosis and treatment are important to prevent the complications of uveitis.

Uvea where uveitis occurs

Symptoms

Eye with uvea

The signs, symptoms and characteristics of uveitis include:

  • Eye redness
  • Eye pain
  • Light sensitivity
  • Blurred vision
  • Dark, floating spots in your field of vision (floaters)
  • Decreased vision

Symptoms may occur suddenly and get worse quickly, though in some cases, they develop gradually. They may affect one or both eyes.

The uvea is the middle layer of tissue in the wall of the eye. It consists of the iris, the ciliary body and the choroid. The choroid is sandwiched between the retina and the sclera. The retina is located at the inside wall of the eye and the sclera is the outer white part of the eye wall. The uvea provides blood flow to the deep layers of the retina. The type of uveitis you have depends on which part or parts of the eye are inflamed:

  • Iritis (anterior uveitis) affects the front of your eye and is the most common type.
  • Cyclitis (intermediate uveitis) affects the ciliary body.
  • Choroiditis and retinitis (posterior uveitis) affect the back of your eye.
  • Diffuse uveitis (panuveitis) occurs when all layers of the uvea are inflamed.

In any of these conditions, the jelly-like material in the center of your eye (vitreous) can become inflamed and infiltrated with inflammatory cells.

When to seek medical advice

Contact your doctor if you think you have the warning signs of uveitis. He or she may refer you to an eye specialist (ophthalmologist). If you’re having significant eye pain and unexpected vision problems, seek immediate medical attention.

Causes

In about half of all cases, the specific cause of uveitis isn’t clear. If a cause can be determined, it may be one of the following:

  • Eye injury or surgery
  • An autoimmune disorder, such as sarcoidosis or ankylosing spondylitis
  • An inflammatory disorder, such as Crohn’s disease or ulcerative colitis
  • An infection, such as cat-scratch disease, herpes zoster, syphilis, toxoplasmosis, tuberculosis, Lyme disease or West Nile virus
  • A cancer that affects the eye, such as lymphoma

Risk factors

People with changes in certain genes may be more likely to develop uveitis. In addition, a recent study shows a significant association between uveitis and cigarette smoking.

Complications

Left untreated, uveitis can cause complications, including:

A New Option

EyePoint Pharmaceuticals’ Yutiq injectable implant should last about the same amount of time as the Retisert implant, and it uses the same corticosteroid found in Retisert at approximately one-third of the dose (0.18 mg vs 0.59 mg), Dr. Suhler says.1

Yutiq, which was FDA approved in October 2018, is supplied in a sterile single-dose preloaded applicator that is administered through an in-office procedure called pars plana intravitreal injection, says Dario Paggiarino, MD, chief medical officer of EyePoint Pharmaceuticals, Inc.

Yutiq is a non-bio-erodible intravitreal micro-insert that employs EyePoint Pharmaceuticals’ Durasert drug delivery technology. It allows for sustained-release delivery of small molecules for up to 3 years with a single local injection. The technology is already being used in 4 other FDA-approved products.

A Better Alternative

The delivery of steroids locally in the eye eliminates the problem of systemic side effects from oral steroids. “The list of adverse side effects from oral steroids is quite lengthy,” says David Callanan, MD, partner at Texas Retina Associates in Dallas, Texas, who conducted clinical trials for Yutiq. Suppressing the immune system systemically can increase the risk of infection. Immunosuppressants also can cause adverse effects like fatigue or gastrointestinal issues.

Contraindications

  • Ocular or periocular infections 
  • Hypersensitivity 

Warnings and Precautions

  • Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection. 
  • Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. 
  • The implant may migrate into the anterior chamber if the posterior lens capsule is not intact. 

Adverse Reactions

  • In controlled studies, the most common adverse reactions reported were cataract development and increases in intraocular pressure. 

Generated

FDA approves Yutiq for persistent non-infectious uveitis


Yutiq, a non-bio-erodible intravitreal micro-insert consisting of 0.18 mg fluocinolone acetonide, obtained FDA authorization for the treatment of persistent non-infectious uveitis impacting the posterior section of the eye.

The FDA got clinical information from 2 randomized, sham injection-controlled, double-masked stage 3 clinical trials of Yutiq with patient follow-up of 3 years. Both trials accomplished the main effectiveness endpoint of prevention of recurrent uveitis flares after 6 months as well as one year, according to the release.

The first test fulfilled its main efficiency endpoint at 6 months with analytical significance (P <.01), as 18.4% of clients treated with Yutiq experienced uveitis recurrence compared to 78.6% of control patients. In the second test, 21.8% of patients treated with Yutiq experienced uveitis reappearance at 6 months compared with 53.8% of control patients (P <.01). The efficiency in both studies was accomplished to 12 months.
The 24- and 36-month follow-up information from the initial stage 3 trial are anticipated to be released by the end of this year as well as the very first half of 2019, specifically, according to the firm.

Uveitis

Summary
Uveitis is a form of eye inflammation. It affects the central layer of tissue in the eye wall (uvea).
Uveitis (u-vee-I-tis) warning signs typically begin suddenly and worsen swiftly. They include eye inflammation, pain and also obscured vision. The condition can affect one or both eyes. It mainly affects individuals ages 20 to 50, but it may also affect kids or younger people.

Possible sources of uveitis are infection, injury, or an autoimmune or inflammatory illness. Often times, a reason cannot be recognized.

Uveitis can be severe and may, bring about long-term vision loss. Early diagnosis as well as treatment are necessary to stop the problems of uveitis from progressing.

Signs and symptoms
Eye with uvea
The indications, signs and qualities of uveitis consist of:
– Eye redness
– Eye discomfort
– Light sensitivity
– Obscured vision
– Dark, drifting areas in your line of vision (floaters).
Reduced vision.

Lazy eye transformation by PI

Signs may occur all of a sudden as well as get worse promptly, though in many cases, they develop gradually. They may affect one or both eyes.

The uvea is the middle layer of tissue in the wall surface of the eye. It consists of the iris, the ciliary body and the choroid. The choroid is sandwiched in between the retina and the sclera. The retina is located at the inside wall surface of the eye and also the sclera is the external white part of the eye wall. The uvea offers blood circulation to the deep layers of the retina. The sort of uveitis you have depends upon which part or parts of the middle layer tissue of the eye are inflamed as follows:


– Iritis (anterior uveitis) affects the front of your eye as well as is one of the most common type.
– Cyclitis (intermediate uveitis) impacts the ciliary body.
– Choroiditis and also retinitis (posterior uveitis) influence the rear of your eye.
– Scattered uveitis (panuveitis) happens when all layers of the uvea are inflamed.

In any one of these conditions, the jelly-like substance in the center of your eye (gel-like) can end up being inflamed as well as infiltrated with inflammatory cells.
When to seek medical advice
Get in touch with your medical professional if you assume you have the warning signs of uveitis. She or he might refer you to an ophthalmologist (eye doctor). If you’re having considerable eye pain and unanticipated vision troubles, look for instant clinical attention.

Causes
In around half of all cases, the specific source of uveitis isn’t clear. If a cause can be established, it might be among the following:.
– Eye injury or surgical procedure
– An autoimmune disorder, such as sarcoidosis or ankylosing spondylitis
– An inflammatory disorder, such as Crohn’s disease or ulcerative colitis
– An infection, such as cat-scratch disease, herpes zoster, syphilis, toxoplasmosis, tuberculosis, Lyme illness or West Nile virus
– A cancer that impacts the eye, such as lymphoma

Risk Factors
Individuals with changes in specific genes might be more probable to get uveitis. Furthermore, a recent study shows a considerable association in between uveitis and also smoking.
Complications

Left neglected, uveitis can create complications, including:.
– Glaucoma
– Cataracts
– Optic nerve damage
– Retinal detachment
– Permanent vision loss

A New Alternative.
EyePoint Pharmaceuticals’ Yutiq injectable dental implant should last about the same amount of time as the Retisert implant, as well as it utilizes the exact same corticosteroid present in Retisert at roughly one-third of the dosage (0.18 mg vs 0.59 mg).
Yutiq, which was FDA approved in October 2018, is provided in a sterilized single-dose preloaded applicator that is carried out through an in-office procedure called the pars plana intravitreal injection.
Yutiq is a non-bio-erodible intravitreal micro-insert that employs EyePoint Pharmaceuticals’ Durasert medicine delivery technology. It permits sustained-release delivery of small molecules for up to 3 years with a solitary local injection. This modern technology is already being used in 4 other FDA-approved medications.

A Better Option
The delivery of steroids locally in the eye eliminates the problem of systemic negative effects from oral steroids. “The list of negative side effects from oral steroids is fairly lengthy. Subduing the immune system systemically can boost the threat of infection. Immunosuppressants likewise can trigger damaging effects like exhaustion or intestinal issues.
Contraindications
– Eye or periocular infections.
– Hypersensitivity

Warnings and Precaution
– Intravitreal injections have actually been associated with endophthalmitis, eye inflammation, raised intraocular pressure, and retinal detachments. Patients should be monitored by their ophthalmologist while taking the injections.
– Use of corticosteroids may generate posterior subcapsular cataracts, raised intraocular pressure, glaucoma, as well as might enhance the establishment of secondary eye infections because of microorganisms, fungi, or viruses.
– The ocular implant may move into the anterior chamber if the posterior lens capsule is not intact.


Adverse Reactions

– In controlled studies, one of the most typical adverse reactions reported were cataract growth and also increases in intraocular pressure.

OCT Screening Before Cataract Surgery So That It Can Boost Outcomes

The regular uses of optical coherence tomography (OCT) to screen candidates for cataract surgical treatment can boost surgery scheduling and planning, give people practical expectations, as well as also cause adjustments in treatment strategies, results from a brand-new research show.
OCT, a relatively new modern technology, is non-invasive and also fast and is ending up being a basic equipment for cataract cosmetic surgeons. However, it is not utilized routinely before cataract surgical procedure almost everywhere.

Khanna Institute Of Lasik
Khanna Institute Of Lasik



Fundus photography is the standard of care after preoperative evaluation, yet it is limited by opaque media and also inadequate student extension,
Overlooked pathologies can lead to suboptimal postoperative outcomes, such as unforeseen low visual acuity and also worsening of the underlying baseline macular pathology.

Research Basis
For this study, the mean age of the individuals was 73.2 years, the mean period from reference to preoperative examination was 59 days, as well as 57% of the people were women.

OCT images showed regular retinas in 50.9% of the eyes as well as problems in 40.3%; 8.8% of the pictures were not interpretable.
The team categorized the macular pathologies as follows: There were 43 eyes with age-related macular degeneration, 27 with epiretinal membrane, 18 with cystoid macular edema, 6 with vitreomacular grip, 4 with lamellar flaws, as well as 4 with some other pathology. Majority of the problems were spotted on OCT – 51.8% – had actually not been spotted throughout the reference examination, which is a huge number.
For 14% of the individuals with previously undetected problems, treatment strategies were altered to mirror the brand-new diagnosis. Surgical treatment was postponed, cataract surgery was integrated with another procedure, or a complement therapy, such as use a vascular endothelial development variable prevention or steroids, was prescribed. None of the 14% qualified for multifocal lenses.

Beverly Hills Los Angeles Lasik Cataract Surgery Santa Monica Lasik



The Cost Question
The only drawback of going through screening is price it is noted. It is claimed a cost-benefit evaluation of screening for patients referred for cataract surgical procedure is needed.

Still, regular screening makes good sense from the perspective of liability, A surgeon could be accused of causing a pathology, such as cystoid macular edema, that existed, however was overlooked throughout testing.

And also the cost is “marginal.” A lot of physicians currently have OCT scanners, not much staff time is required, and capturing pathologies can conserve money “on the back end.”.

The degree to which specialists can bill for OCT screening carried out prior to surgery is vague, says an ophthalmologist in Cherry Hillside, New Jersey, who is also a professional speaker for the AAO.
” When you utilize words ‘testing,’ most insurance firms, consisting of Medicare, will not spend for it,” he told Medscape Medical News.
As well as when Medicare does reimburse for OCT, Goel said his technique gets $41.70. “If you’re evaluating every person as well as not charging the healthcare system, that’s penalty. If you add an added $40 to every cataract preoperative check out, that would add real money.”



DRY EYES AND LASIK

Findings from a large population-based study of patients presenting themselves for refractive surgery, challenge conventional wisdom about dry eye and LASIK, reported Julie Schallhorn, MD, MS, at ASCRS Refractive Day, being held during the annual meeting at the Convention Center in San Diego, CA.

Khanna Institute Of Lasik
Khanna Institute Of Lasik

Dr. Schallhorn, assistant professor of Ophthalmology, University of California San Francisco, presented evidence addressing the following three commonly held beliefs:

  • Dry eye that is present before LASIK will get worse after LASIK
  • Women are much more likely than men to get bad dry eye after LASIK
  • Patients with dry eye should have PRK instead of LASIK because LASIK will make their dry eye worse

According to the study:

  • Dry eye that is present before LASIK tends to get better after surgery
  • Female gender has a “very, very” small effect on worsening of dry eye after surgery
  • At 3 months after surgery, patients who had PRK report more dry eye symptoms than patients who had LASIK

“LASIK has been around for a long time, and there are certain beliefs about it that according to data from our study do not hold true,” she said.

Watery Dry Eyes

Power from a large population

The analyses examining the truths about LASIK and dry eye were performed using data collected from confidential questionnaires that were completed preoperatively and three months after surgery by patients who presented themselves for refractive surgery over a two-year period. It included more than 12,000 patients (>24,000 eyes) who represented a wide range of ages and were comprised of a slight preponderance of females.

“Because we had a very large population, our study had a lot of power to detect statistically significant differences,” Dr. Schallhorn said.

Overall, 41.5% of patients reported experiencing dry eye symptoms before surgery, and the severity ranged from very mild to very severe. Analyses to identify variables associated with dry eye identified only two factors – female gender and contact lens wear.

“Women were 23% more likely than men to reported dry eye symptoms and contact lens wearers were 45% more likely to report dry eye symptoms than their counterparts who were not wearing contact lenses,” Dr. Schallhorn said. “We found, however, that age, refractive error, and season of treatment were not associated with having dry eye symptoms post-operatively.”

Facts about dry eye worsening

Analyses looking at changes in dry eye symptoms after surgery showed that some patients developed dry eye de novo after surgery. Patients who reported dry eye preoperatively, however, tended to get better. The tendency for improvement was observed across the spectrum of preoperative dry eye severity levels, but patients who reported the worst dry eye before surgery had the biggest improvement postoperatively.

“What our study shows is that dry eye before surgery does not necessarily equal dry eye after surgery,” Dr. Schallhorn said.

She proposed that the tendency for dry eye to get better after surgery is probably the result of several factors.

“We treat existing ocular surface diseases before surgery is performed, patients are getting engaged in their ocular health, and we are getting patients out of their habit of wearing contact lenses,” Dr. Schallhorn explained.

The gender effect

Across all age groups, females reported worse dry eye symptoms after surgery than men, but analysis of the change in symptoms from preoperative to postoperative showed that female gender had only a small effect on the change in dry eye symptom severity after surgery.

“The effect of gender was highly statistically significant because of our large population, but clinically, the effect was so small that I think it is not something that needs to be emphasized to patients,” Dr. Schallhorn said.

Surgery decision-making

An overwhelming majority of patients in the study underwent LASIK. Data on preoperative dry eye symptoms showed no significant difference comparing patients who went on to have PRK versus those who had LASIK.

Results from multivariable regression modeling done to identify factors associated with change in dry eye symptoms from pre- to postoperatively found only three independent predictors, and of the three, PRK had the strongest effect. Female gender was also associated with greater worsening of dry eye, and there was an inverse correlation between preoperative dry eye symptom score and worsening after surgery, Dr. Schallhorn said.

Age, ablation pattern (wavefront-guided versus standard), type of refractive error (myopia versus hyperopia), and preoperative contact lens wear were not independently associated with worsening of dry eye after surgery.

Discussing the implications of the study for patient care, Dr. Schallhorn concluded that surgeons still have to inform patients that there is a possibility of developing dry eye after surgery. 

“But the findings of our study give me greater confidence to tell patients who are contact lens wearers and uncomfortable because of dry eye symptoms that they will probably get better after surgery,” she said.

Generated

      
DRY EYES AND LASIK

Findings from a large population-based study of patients presenting themselves for refractive surgical treatment challenge conventional wisdom about dry eye and LASIK. An Assistant professor of Ophthalmology, University of San Francisco, provided evidence resolving the myths associated with three typically held notions:

  • Dry eye that exists before LASIK will certainly get worse after LASIK
  • Females are far more likely than men to get severe dry eye after LASIK
  • Patients with completely dry eye must have PRK instead of LASIK due to the fact that LASIK will certainly make their completely dry eye worse

According to the study:

  • Dry eye that exists prior to LASIK often tends to improve after surgical procedure
  • Women gender has a “extremely, really” little effect on getting worse dry eye after surgical treatment
  • At 3 months after surgical treatment, people that had PRK report even more dry eye signs and symptoms than clients who had LASIK

” LASIK has been around for a very long time, and also there are particular beliefs about it that according to data from our research do not apply,” she claimed.


Power from a big population
The analyses checking out the facts concerning LASIK and dry eye were executed using information gathered from private questionnaires that were completed preoperatively as well as 3 months after surgical treatment by people who presented themselves for refractive surgery over a two-year period. It consisted of greater than 12,000 patients (> 24,000 eyes) who had a large age range and also consisted of a small over-prevalence of ladies.


” Due to the fact that we had a very large population, the research had a lot of power to identify statistically considerable distinctions,” stated ophthalmologist.
In general, 41.5% of people reported experiencing completely dry eye symptoms prior to surgery, and the intensity ranged from really light to very severe.

Evaluations to identify variables connected with completely dry eye identified just 2 elements– women gender as well as contact lens wear.

“Ladies were 23% more likely than guys to report completely dry eye symptoms and contact lens wearers were 45% more likely to report dry eye symptoms than their counterparts who were not using contact lenses,”  A team of doctors said “We discovered, nevertheless, that age, refractive mistake, and season of treatment were not associated with having dry eye signs post-operatively.”

Truths regarding completely dry eye intensifying  

Evaluations checking out adjustments in dry eye symptoms after surgical treatment revealed that some patients established dry eye afresh after surgery. Patients who reported dry eye preoperatively, nonetheless, tended to improve. The propensity for improvement was observed throughout the spectrum of preoperative dry eye seriousness levels, yet individuals who reported the most awful dry eye prior to surgical treatment had the greatest improvement postoperatively.

“What our study reveals is that dry eye prior to surgical treatment does not always equivalent completely dry eye after surgical treatment,” the doctor stated.

She recommended that the tendency for dry eye to improve after surgery is possibly the outcome of several aspects. “We deal with existing eye surface disease before surgery is done, patients are getting engaged in their ocular health and wellness, and we are getting patients out of their habit of contact lenses,” the doctor clarified.


The gender result

Throughout every age group, women reported even worse completely dry eye signs after surgical procedure than males, however analysis of the modification in signs and symptoms from preoperative to postoperative showed that women sex had just a tiny impact on the change in completely dry eye extent after surgery. The effect of gender was highly statistically significant due to our huge population, yet scientifically, the effect was so tiny that I think it is not something that requires to be stressed to people,” the doctor claimed.


Surgery decision-making

A large majority of individuals in the study undertook LASIK. Information on preoperative dry eye signs and symptoms revealed no considerable distinction contrasting patients who took to having PRK versus those who had LASIK.
Results from multivariable regression modelling done to identify variables connected with adjustment in dry eye signs from pre- to post-operatively discovered only three independent predictors, as well as of the 3, PRK had the greatest result. Female gender was likewise related to greater worsening of dry eye, as well as there was an inverse correlation in between preoperative completely dry eye signs and symptom score and also worsening after surgical treatment, ophthalmologist stated.

Age, ablation pattern (wave front-guided versus standard), some sort of refractive error (myopia versus hyperopia), and preoperative contact lens wear were not separately associated with worsening of completely dry eye after surgery.

Going over the implications of the study for patient treatment, the doctor concluded that cosmetic surgeons still have to educate patients that there is an opportunity of establishing dry eye after surgery.


“However, the findings of our study give me higher self-confidence to inform patients that are contact with lens wearers as well as are uneasy because of dry eye signs that they will most likely get better after surgical procedure,” she claimed.