FDA approves treatment for leading cause of vision loss…

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BREAKING MEDICAL NEWS — INTERVIEW OPPORTUNITY
FOR MONDAY, NOVEMBER 18, 2019

FDA APPROVES NEW TREATMENT FOR WET AMD, A LEADING CAUSE OF VISION LOSS

It’s estimated by next year, 1.5 to 1.75 million people in the US will be living with WET AGE-RELATED MACULAR DEGENERATION (wet AMD). It’s a leading cause of vision loss and a rapidly growing public health concern.[1-3]

It can start with your vision becoming distorted. It’s harder to see objects clearly.[4] If allowed to progress, it could lead to complete loss of central vision, leaving you unable to read, drive or even recognize familiar faces.[5]

Novartis has just received FDA approval of a new treatment that has the potential to help people affected by wet AMD maintain their vision.

Dr. Peter Kaiser, Director of the Cole Center for Ocular Research and Evaluation and Professor of Ophthalmology at the Cleveland Clinic, knows what patients and their families go through with this disease. He is available to answer your questions and to discuss:

How wet AMD robs people of precious sight and impacts millions of lives
Ways to detect wet AMD
New treatment option for wet AMD
Resources to help people cope with this condition
Challenges of caring for someone with AMD

When you book, we will provide you with supplemental b-roll, guest bio & suggested questions.
Interview courtesy of Novartis Pharmaceuticals Corporation.

INDICATIONS AND USAGE
BEOVU® (brolucizumab-dbll) injection is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
BEOVU is contraindicated in patients with ocular or periocular infections, active intraocular inflammation or known hypersensitivity to brolucizumab or any of the excipients in BEOVU. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

Please see additional Important Safety Information below and the full Prescribing Information.

WARNINGS AND PRECAUTIONS

Endophthalmitis and Retinal Detachments
Intravitreal injections, including those with BEOVU, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering BEOVU. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

Increase in Intraocular Pressure
Acute increases in intraocular pressure (IOP) have been seen within 30 minutes of intravitreal injection including with BEOVU. Sustained IOP increases have also been reported. Both IOP and perfusion of the optic nerve head must be monitored and managed appropriately.

Thromboembolic Events
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the BEOVU clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The ATE rate in the two controlled 96-week neovascular AMD studies (HAWK and HARRIER) during the first 96-weeks was 4.5% (33 of 730) in the pooled brolucizumab arms compared with 4.7% (34 of 729) in the pooled aflibercept arms.

ADVERSE REACTIONS

Serious adverse reactions including endophthalmitis, retinal detachment, increases in intraocular pressure, and arterial thromboembolic events have occurred following intravitreal injections with BEOVU.

The most common adverse events (≥5% of patients) with BEOVU were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye pain.

As with all therapeutic proteins, there is a potential for an immune response in patients treated with BEOVU. Anti-brolucizumab antibodies were detected in the pre-treatment sample of 36% to 52% of treatment naive patients. After initiation of dosing, anti-brolucizumab antibodies were detected in at least one serum sample in 53% to 67% of patients treated with BEOVU. Intraocular inflammation was observed in 6% of patients with anti-brolucizumab antibodies detected during dosing with BEOVU. The significance of anti-brolucizumab antibodies on the clinical effectiveness and safety of BEOVU is not known.

Please see full Prescribing Information.

[1] Friedman DS, O’ Colmain BJ, Munoz B, et al. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004;122(4):564-572.
[2] Klein R, Chou CF, Klein BE, Zhang X, Meuer SM, Saaddine JB. Prevalence of age-related macular degeneration in the U.S. population. Arch Ophthalmol. 2011;129(1):75-80.
[3] American Academy of Ophthalmology. Age-related macular degeneration preferred practice patterns. https://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp-2015. Accessed March 2019.
[4] NHS Choices. Macular Degeneration – Symptoms. http://www.nhs.uk/Conditions/Macular-degeneration/Pages/Symptoms.aspx. Accessed January 2019.
[5] World Health Organization. Priority eye diseases: Age-related macular degeneration. http://www.who.int/blindness/causes/priority/en/index7.html. Accessed January 2019.

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