January 17

FDA APPROVES BAK FREE LATANOPROST FOR BETTER RESULTS

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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.


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