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FDA APPROVES BAK FREE LATANOPROST FOR BETTER RESULTS

Latanoprost, sold under the brand name Xalatan among others, is a medication used to treat increased pressure inside the eye. This includes ocular hypertension and open angle glaucoma. It is applied as eye drops (topical therapy) to the eyes. Onset of effects is usually within four hours, and they last for up to a day.

Khanna Institute Of Lasik
Khanna Institute Of Lasik

Latanoprost was approved for medical use in the United States in 1996. It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system. Latanoprost is available as a generic medication.

In people with ocular hypertension (IOP ≥21 mm Hg) including open-angle glaucoma, treatment with latanoprost reduced IOP levels by 22 to 39% over 1 to 12 months’ treatment. Latanoprost was more effective than timolol 0.5% twice daily in 3 of 4 large (n = 163 to 267) randomised, double-blind trials. Latanoprost demonstrated a stable long-term IOP-lowering effect in 1- or 2-year continuations of these trials, with no sign of diminishing effect during prolonged treatment.

Glaucoma and Lasik Eye Surgery Beverly Hills Thousand Oaks Los Angeles

Topical therapy is typically first-line treatment for patients with newly diagnosed glaucoma. All multidose ophthalmic medications are required to have a preservative to maintain an antimicrobial environment in the bottle, making it important for eye care providers to understand the effects of preservatives on the ocular surface. Unfortunately, most preservatives in ophthalmic medications disrupt the ocular surface and exacerbate pre-existing ocular surface disease (OSD). Benzalkonium chloride (BAK) is the most widely used preservative in antihypertensive topical medicines, and many studies have clearly demonstrated BAK’s toxic effects on corneal and conjunctival epithelium. Although most antiglaucoma eye drops are manufactured with very little BAK, doses as small as 0.0001% are toxic to ocular tissue.

AT A GLANCE

• The prolonged use of eye drops preserved with benzalkonium chloride (BAK) is a strong risk factor for ocular surface disease in patients with glaucoma.

• In the past decade, the pharmaceutical industry has sought to address the need for BAK-free options to reduce ocular surface disease and increase patients’ comfort. These options fall into two categories: BAK free preserved medicines (using alternative preservatives to BAK) and preservative-free medicines.

• Reducing patients’ overall preservative load may improve adherence, quality of life, and the patient doctor relationship.

Because glaucoma is a chronic disease, the initiation of topical therapy also begins a patient’s long-term exposure to preservatives. The prolonged use of BAK-preserved drops is a strong risk factor for OSD in patients with glaucoma. Furthermore, the toxic effect of BAK is additive, and patients who must use two or more medications have worse OSD.

It is no surprise, then, that the prevalence of OSD among individuals with glaucoma is high, with roughly half of all patients on long-term glaucoma therapy reporting adverse ocular symptoms. There is thus a clear need for BAK-free glaucoma treatment options to minimize OSD and to improve patients’ quality of life. Goldberg at al found that patients who switched to BAK-free medications needed fewer lubricant drops and reported an improvement in dry eye symptoms. The study also showed no significant change in IOP from pre-study levels.

Preservative-Free Medicine

Three topical glaucoma medications completely free of preservatives are available in the United States: Zioptan (tafluprost ophthalmic solution 0.0015%; Akorn), Cosopt PF (dorzolamide-timolol ophthalmic solution 2%/0.5%; Akorn), and Timoptic in Ocudose (timolol maleate ophthalmic solution 0.25% and 0.5%; Valeant Pharmaceuticals). Because of the lack of antimicrobial activity in the solution, all of these products are supplied as a sterile solution in a single-use container. Once it is opened, medication is applied to the eye, and patients should then immediately discard the container and its remaining contents. Zioptan must be stored refrigerated at 2º to 8°C (36º-46°F).

The FDA has approved a new drug application called Xelpros to reduce IOP in open-angle glaucoma and ocular hypertension, Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company announced in a joint press release.

Xelpros (latanoprost ophthalmic solution 0.005%) is the first latanoprost product not formulated with the preservative benzalkonium chloride and was developed with SPARC’s Swollen Micelle Microemulsion technology, the release said.

It was shown to reduce IOP in patients with open-angle glaucoma and ocular hypertension up to a mean of 6 mm Hg to 8 mm Hg in randomized clinical trials.

“As the only BAK-free version of latanoprost, Xelpros will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” Sun Pharma North America CEO Abhay Gandhi said in the release.

Safety and Efficacy

Across randomized clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline Intraocular pressure (IOP) of 23-26 mmHg, XELPROSTM, administered once daily in the evening lowered IOP by a mean of up to 6-8 mmHg.

The most frequently reported adverse reactions were eye pain/stinging upon instillation and ocular hyperaemia (redness), reported in 55% and 41% of patients treated with XELPROSTM respectively. Less than 1% of patients discontinued therapy because of intolerance to these adverse events.

Aside from the frequently reported adverse reactions, common side effects of all topical Latanoprost ophthalmic products are:

• Pigmentation of the iris (likely to be permanent), periorbital tissue (eyelid) and eyelashes can occur; and

• Eyelash changes such as gradual change to eyelashes including increased length, thickness and number of lashes, which is usually reversible upon discontinuation of treatment.

Other Warnings and Precautions

Intraocular Inflammation: XELPROSTM should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

Macular Edema: XELPROSTM should be used with caution in aphakic patients, in pseudophakia patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Herpetic Keratitis: XELPROSTM should be used with caution in patients with a history of herpetic keratitis. XELPROSTM should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.

Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.

Use with Contact Lenses: Contact lenses should be removed prior to administration of XELPROSTM and may be reinserted 15 minutes following administration.

Generated

FDA APPROVES BAK FREE LATANOPROST FOR BETTER RESULTS

Latanoprost, is a medication utilized to deal with boosted pressure inside the eye. This consists of eye high blood pressure as well as open angle glaucoma. It is applied as eye drops (topical treatment) to the eyes. Start of effects is typically within 4 hours, and also, they last for as much as a day.

Latanoprost was authorized for medical usage in the USA in 1996. It is on the World Health Organisation’s Listing of Essential Medicines, the most reliable as well as safe medications required in a health system. Latanoprost is available as a generic medicine.

In people with eye hypertension (IOP ≥ 21 mm Hg) consisting of open-angle glaucoma, treatment with latanoprost minimized IOP levels by 22% to 39% over 1 to 12 months’ treatment. Latanoprost showed a secure lasting IOP-lowering effect in 1- or 2-year extensions of these tests, without any indicator of reducing effect throughout prolonged treatment.

Topical therapy is commonly first-line therapy for people with freshly diagnosed glaucoma. All multidose sensory medications are required to have a chemical to preserve an antimicrobial environment in the container, making it crucial for eye care companies to understand the results of chemicals on the ocular surface area. Regrettably, most chemicals in ophthalmic medications interfere with the ocular surface area and also aggravate pre-existing ocular surface disease (OSD). Benzalkonium chloride (BAK) is one of the most widely made use of preservative chemicals in antihypertensive topical medications, and numerous studies have actually clearly shown BAK’s hazardous impacts on corneal as well as conjunctival epithelium. Although the majority of anti-glaucoma eye drops are made with really little BAK, dosages as little as 0.0001% are harmful to eye cells.

At A Glance

– The extended use of eye drops protected with benzalkonium chloride (BAK) is a solid threat element for ocular surface disease in people with glaucoma.

– In the previous decade, the pharmaceutical industry has actually sought to address the requirement for BAK-free choices to reduce eye surface disease and boost individuals’ convenience. These options fall under 2 classifications: BAK free maintained medicines (using alternative chemicals to BAK) and preservative-free medicines.

– Minimizing patients’ overall chemical usage may improve adherence, lifestyle, and the patient doctor relationships.

Because glaucoma is a persistent disease, the initiation of topical treatment additionally begins a client’s lasting exposure to preservatives. The prolonged use of BAK-preserved eye drops is a solid risk factor for OSD in people with glaucoma. Additionally, the harmful result of BAK is additive, and clients that need to use 2 or even more medications have worse OSD.

It is not a surprise, after that, that the prevalence of OSD amongst individuals with glaucoma is high, with about half of all individuals on long-term glaucoma treatment reporting adverse ocular symptoms. There is hence a clear demand for BAK-free glaucoma treatment alternatives to reduce OSD and also to enhance people’s lifestyles. Goldberg at al discovered that clients that changed to BAK-free medications required fewer lubricant drops and also reported an improvement in completely dry eye signs. The study also revealed no substantial modification in IOP from pre-study levels.

Preservative-Free Medicine

3 topical glaucoma medicines totally without preservatives are readily available in the United States: Zioptan (tafluprost ophthalmic solution 0.0015%; Akorn), Cosopt PF (dorzolamide-timolol ocular solution 2%/ 0.5%; Akorn), and also Timoptic in Ocudose (timolol maleate ocular solution 0.25% and also 0.5%; Valeant Pharmaceuticals). Due to the lack of antimicrobial elements in the solution, every one of these items are supplied as a sterile medicine in a single-use container. Once it is opened up, medicine is put on the eye, and also people must then right away throw out the container as well as its remaining components. Zioptan needs to be kept refrigerated at 2º to 8 ° C( 36º-46 ° F). 

The FDA has actually authorized a brand-new drug application called XelprosTM to lower IOP in open-angle glaucoma and also ocular high blood pressure, Sunlight Pharmaceutical Industries as well as Sunlight Pharma Advanced Research announced in a joint press release.

XelprosTM (latanoprost ocular solution 0.005%) is the initial latanoprost product not formulated with the preservative benzalkonium chloride and also was created with SPARC’s Swollen Micelle Microemulsion technology, the release stated.

It was found to reduce IOP in people with open-angle glaucoma and also ocular hypertension approximately by a mean of 6 mm Hg to 8 mm Hg in randomized clinical tests.

“As the only BAK-free variation of latanoprost, XelprosTM will certainly be an essential and different treatment alternative for people with open-angle glaucoma or ocular high blood pressure,” Sun Pharma, the United States And Canada Chief Executive Officer Abhay Gandhi stated in the release.

Safety as well as Effectiveness

Across randomized scientific trials of patients with open-angle glaucoma or ocular hypertension with a mean standard Intraocular pressure (IOP) of 23-26 mmHg, XELPROSTM, carried out daily at night decreased IOP by a mean of as much as 6-8 mmHg.

The most regularly reported unfavourable reactions were eye pain/stinging upon instillation and eye hyperaemia (inflammation), reported in 55% as well as 41% of people treated with XELPROSTM respectively. Less than 1% of patients terminated therapy as a result of intolerance to these adverse conditions.

Aside from the often-reported adverse reactions, usual negative effects of all topical Latanoprost ocular products are:

– Pigmentation of the iris (likely to be long-term), periorbital tissue (eyelid) as well as eyelashes can happen; and also

– Eyelash adjustments such as steady modification to eyelashes including raised size, thickness and also variety of lashes, which is usually reversible upon discontinuation of therapy.

Other Cautions as well as Preventative measures

Intraocular Inflammation: XelprosTM must be made use of with caution in individuals with a history of intraocular swelling (iritis/uveitis) and should normally not be made use of in patients with active intraocular inflammation.

Macular Edema: XelprosTM should be made use of with care in aphakic individuals, in pseudophakia patients with a torn posterior lens capsule, or in individuals with well-known threat variables for macular edema.

Herpetic Keratitis: XelprosTM needs to be utilized with care in people with a history of herpetic keratitis. XelprosTM needs to be avoided in instances of active herpes simplex keratitis due to the fact that swelling might be intensified.

Bacterial Keratitis: There have actually been records of bacterial keratitis related to the use of multiple-dose containers of topical ocular items.

Usage with Contact Lenses: Contact lenses should be removed before administration of XelprosTM as well as might be returned 15 mins adhering to administration.

LASIK’S MYTHS AND REALITIES

LASIK can be a hazardous operation.

Khanna Institute Of Lasik
Khanna Institute Of Lasik

Myth

LASIK vision adjustment is exceptionally secure when executed by a respectable specialist. As a matter of fact, several clinics around the nation experience a higher success rate than the national standard, having actually performed literally tens of hundreds of vision modification surgical procedures.

LASIK is for any individual.
Myth 

LASIK eye surgical treatment can be a very rewarding treatment, however is not an optimum option for every person. A detailed evaluation by an Ophthalmologist (M.D.) who concentrates on LASIK can establish if you are an excellent candidate for LASIK. Eye care experts conduct an extensive LASIK assessment lasting approximately 2 hrs throughout which all aspects of your eyes and your vision are checked out. Numerous clinics use cutting edge technology, consisting of the Pentacam, which draws up a patient’s cornea. Like your finger print, your cornea is one-of-a-kind to you. From thickness to structural stability, recognizing corneal features is among the most important consideration in recognizing good LASIK surgery candidates.

Middle-aged and senior people can have LASIK.

Reality

According to the FDA, LASIK prospects have to be 18 to have vision modification surgical treatment. There is truly no age that makes somebody as well old to have LASIK. There are obviously eye problems that feature age-related issues that might make an older person a non-candidate. As an example, if somebody has cataracts, the cataract needs to initially be taken care of prior to considering LASIK. Stability also stays a vital determining factor for LASIK. If older individuals wish to have their distance and analysis vision fixed, both require to be stable prior to moving forward with vision improvement surgery.


LASIK prospects can only obtain one sort of vision improvement surgery.
Misconception

Lots of people hear LASIK and immediately believe there is just one procedure. LASIK has actually been adopted and frequently used for all vision correction surgical treatment; however, there are numerous alternatives. Because of the special structure of every prospect’s eyes, a candidate that is not fit for all-laser LASIK might be perfectly suited for all-laser PRK (also called no flap LASIK).

Immediate Improvement After Lasik Surgery


LASIK price cuts appear too great to be true.

Reality 

Your eye health and wellness can extremely affect your overall wellness. Compromising surgeon experience, technology, or individual care after a reduced clinical expense is an unsafe option when it involves LASIK surgery. While short-term economic cost savings are appealing, your eye may sustain long-term physical effects from a poor treatment. Find a trustworthy ophthalmologist who focuses on LASIK and wants to openly talk about cost with you. Honest, uncomplicated prices remove assumption and also makes the most of healthy client to medical professional communication.


People with astigmatism cannot have LASIK.
Misconception

With the enhancements in modern technology over the past several years, having astigmatism does not normally cause an issue when thinking about LASIK. Many LASIK clinics have actually purchased modern technology and can easily and consistently right astigmatism with LASIK eye surgical procedure.

During a LASIK treatment, a person has to keep their eyes still as well as open by themselves.

Misconception

When researching LASIK surgical procedure, lots of people ask the concerns, “Do I need to keep my eye completely still?” and “Exactly how am I intended to keep my eye open?” At our clinic, we make use of innovative technology that track patients’ eyes with several infra-red electronic cameras at a rate of 400 frames per secondly. When it involves keeping someone’s eyes open during LASIK, your eye care doctor will certainly put numbing drops in your eyes, removing the need to blink. A tiny tool is then positioned around the eye to keep it open throughout the treatment.


Recuperation after LASIK only takes 24-48 hrs.

Fact. 

Patients who have LASIK requireme somebody to drive them to their residence. It is recommended that you take a lengthy snooze lasting around 4 hrs, after which significant restoration will certainly be noticed. Additional vision improvement should occur by the following morning. The specific length of “healing time” is patient reliant as well as during your appointment, your LASIK specialist ought to have the ability to set a sensible assumption. Usually, patients are able to go back to their normal daily activities the following day with some restrictions around swimming, contact sporting activities and other similar activities of that nature.

Why Lasik Eye Surgery is so Popular?

LASIK eye surgical procedure, which is a vision correction treatment, is preferred for 2 key reasons – post-surgery recovery time is reasonably brief as well as the operation not only takes about 15 minutes per eye but it is reasonably a pain-free operation. It is very typical for people to regain their vision the day after being operated.

Khanna Institute Of Lasik
Khanna Institute Of Lasik



LASIK is actually not a new treatment for it has actually been around since the early 1980s. It was quite unknown after that because the treatments call for manually dissecting the cornea and not many physicians could handle it. However, with the advent of technology, lasers were made use of rather and LASIK sprang to life as it corrects vision rapidly and also painlessly.

Corneal Requirements for Lasik Surgery



The surgery process itself
The surgery primarily entails developing a flap in the cornea. Surgeons make use of either a microkeratome or laser to accomplish this job. As soon as the flap is developed, it is folded back to get to the layers beneath. After that the doctor will utilize an ultraviolet beam to improve the cornea. Once that is done, the flap is put into its original position. The whole procedure typically takes about 15 mins or less.

LASIK is suitable for both farsighted and myopic people since lasers can be made use of to improve the cornea. That is why people with eye problems such as astigmatism normally go for LASIK although astigmatism can be treated with various other techniques, relying on the intensity of the issue and budget plan.

What takes place after the surgical procedure over?
There is no demand to stay overnight in the medical facility. The operation itself takes about 15 mins or less as well as a number of hours rest is usually deemed enough. They will after that be released and allowed to rest. Guideline is to eye-shield the operated eye for a day after the procedure. Do note that several hours after the procedure, there may be some irritability. Painkillers are generally used to treat this typical trouble. Some have watery eyes, irritation or really feel having a blurry vision but it’s very normal. Just remember not to massage the eyes as it might damage the corneal flap.

When to return to work as well as play
People usually feel they can resume work a day or two after the procedure but the best to do is to relax for a week as well as avoid activities which can stress the eyes. Avoid enjoying contact sports additionally, until a month or so has actually passed to allow the eyes to recover correctly.

Go with a check-up
Eye exam is normally called for few days after the procedure, and doctors will typically recommend making use of eye drops to consist of swelling or infections. Remain free from contact lenses unless your medical professional has actually okayed for them to be put on.

Long Term Care
Total healing is approximated at six months. It, nevertheless, does not imply that the patient relaxes around their home for that time period. Regular eye exam is advised as any type of possible problems could be dealt with early.

ProQR’s retinitis pigmentosa treatment obtains orphan medication classification

                             

ProQR's retinitis pigmentosa treatment obtains orphan                           medication classification
ProQR’s retinitis pigmentosa treatment obtains orphan medication classification

QR-1123, a first-in-class investigational antisense oligonucleotide for the therapy of vision loss associated with autosomal leading retinitis pigmentosa, obtained an orphan medicine classification from the FDA, ProQR announced in a press release.

Khanna Institute Of Lasik
Khanna Institute Of Lasik

” We are pleased to have orphan drug classification for our QR-1123 program targeting autosomal leading to retinitis pigmentosa, or adRP,” said Daniel de Boer, Chief Executive Officer of ProQR. “It highlights the unmet need for individuals with this progressive disease, causing blindness. Our objective is to develop and actively break through a pipe of programs that can treat inherited retinal diseases like adRP in a targeted way.”

Dr. Khanna, Surgeon to the stars

QR-1123, which is made to be administered via intravitreal injections, intends to prevent the harmful variation of the rhodopsin protein by binding the P23H mutation in the RHO genetics.

Discovered and also developed by Ionis Pharmaceuticals, it was licensed by ProQR in 2018 as well and has since received IND clearance and a fast lane designation from the FDA.

Bulging Eyes

Bulging eye

New Step by Step Roadmap for Bulging Eye

Your eyes may appear different from one another. Otherwise, the eye should be removed (enucleation). Our eyes are among the most sensitive sections of our whole body and thereby are definitely the most vulnerable to danger. Black eye occurs owing to a blow to the eye or because of an illness or trauma. Prominent eyes are usually hereditary and in the majority of cases are harmless. They may be a family trait.

In instances of severe pop-eye it’s feasible for the eye to rupture. Make sure there isn’t any discharge around the eyes, and they look clear and bright. In most instances, if your cat’s eye is now swollen, you should stop by the veterinarian once possible.

The eye disease treatment should be accomplished by means of a medical care professional. The challenging role in bulging eye treatment is to figure out the underlying cause. Eye socket pain treatment can fluctuate in line with the causes and symptoms.

What About Bulging Eye?

In extreme situations, surgery may be required. You might require hospitalization and a sort of surgery called an iridectomy to stop different attacks if treatments like eye drops to reduce the pressure in the eye don’t do the job. The quantity of surgery required is affected by the seriousness of disease and level of proptosis. If it is necessary, your doctor may remove your entire thyroid gland to eliminate the risk of hyperthyroidism returning. Eyelid surgery in Frederick, MD, might need to be combined with other surgical procedures to provide the best outcomes. There are lots of reasons you may be considering eyelid surgery. Eyelid surgery in Maryland is a favorite choice for individuals that are faced with drooping eyelids, which can make them look older and not as alert.

Eye cancer is comparatively rare, with retinoblastoma being the most frequently encountered kind of eye cancer. Pop eye disease in fish might be caused due to a mix of many issues or might be the symptom of an underlying bacterial infection. Typically it occurs because of an infection of the eye or a trauma, though it can also occur if the hamster is restrained too tightly from the rear of the neck. To sum up, thyroid eye disease is a state that is rare, and as soon as it does affect someone, the signs are usually mild and warrant minimal or no therapy. In a nutshell, if you’re experiencing Thyroid Eye Disease, choosing surgical treatments for the exact same can be a rewarding choice. Also, you shouldn’t be suffering from any eye diseases. Pop eye disease in Goldfish or cichlids is not hard to identify, but quite tough to take care of.

Indicators of eye cancer can fluctuate from person to person based on the sort of cancer involved. Indicators of eye socket pain may change from person to person, depending upon the reason for the pain. Some might not know they have an eye disorder and some just decide to ignore it. Symptoms and vision changes worsen as you get older, therefore it’s important to schedule an eye exam to ensure you’ve got keratoconusand locate the ideal treatment after possible.

New Questions About Bulging Eye

In severe instances, your eyelids can’t cover the full front of your eye. The eyelids additionally help to safeguard the attention. Folks have a tendency to ignore their puffy or swollen eyelids which are often caused by substantial stress in their livesa present of today’s lifestyle.

Characteristics of Bulging Eye

Because it can help to protect against drying of your eyes. Sometimes eyes can seem to be bulging every time an individual has lost plenty of weight. In the event the eye has sustained a physical injury it might also be bloodstained. The easy reason it’s so hard to treat is because the pop eye can be brought about by various things, and zeroing on the precise causative element is hard.

In severe instances of exophthalmos, you might not be in a position to close your eyes properly. If just one eye is infected then it’s likely the end result of an injury. Cloudy eyes are quite frequently a sign of an issue with water parameters.

In some instances, the eye could possibly be cloudy, other times it will seem normal other than being swollen. Even if you’re ready to successfully set the eye, get to the vet as soon as possible. Our eyes are among the most significant sections of our physique. In instances of sub-par water chemistry, the eye might be cloudy together with swollen. Bulging eyes ought to be checked by means of a medical care provider without delay. They can be a symptom of something more serious in most cases. They are usually a symptom of another condition.

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