The effect lasts for 12 weeks! Novartis ophthalmology new drugs announced the latest results

The effect lasts for 12 weeks! Novartis ophthalmology new drugs announced the latest results

May 07, 2018 Source: WuXi PharmaTech

Recently, Novartis released the latest pre-specified secondary analysis of brolucizumab (RTH258) in the clinical phase 3 trial (HAWK and HARRIER trials) for the treatment of neovascular age-related macular degeneration (nAMD, also known as wet macular degeneration). result. The data shows that this dosing interval can be maintained up to 48 weeks as long as the patient is assessed for a 12 week dosing interval during the first 12 week period after dosing. These patients were successfully maintained in the HAWK trial and the HARRIER trial with a probability of 87% and 83%, respectively, at a 12-week dosing interval of up to 48 weeks. This is the first time in a phase 3 trial that prospectively demonstrated high reliability for a pre-designated secondary endpoint of anti-vascular endothelial growth factor (VEGF) treatment at 12-week dosing intervals.

nAMD is the leading cause of severe vision loss and blindness in the elderly, affecting approximately 20-25 million people worldwide. The macula is the area responsible for fine, central vision in the retina. nAMD usually occurs when abnormal blood vessels form and grow under the macula. These blood vessels are very fragile, and the leaking fluid destroys the normal structure of the retina and eventually causes damage to the photoreceptor cells. As the disease progresses and cell damage worsens, the patient's vision will be further reduced until the final loss of central vision. If left untreated, vision can deteriorate within a few days. However, there is currently no cure for macular degeneration in the medical community. Injecting drugs into patients' eyes can delay the progression of the disease and help patients maintain and improve their vision.

Novartis's brolucizumab is an intraocular drug for this disease. It is a humanized single-chain antibody fragment (scFv) that has been shown to inhibit the activation of VEGF receptors by preventing ligand and receptor interactions in preclinical studies. Increased signaling through the VEGF pathway is associated with pathological ocular angiogenesis and retinal edema, so inhibition of the VEGF pathway can inhibit the growth of neovascularization, relieve retinal edema, and improve vision in patients with choroidal retinopathy.

HAWK and HARRIER were prospective, randomized, double-blind, multicenter studies that lasted for 96 weeks, recruiting 1,800 nAMD patients from 400 centers worldwide. Both trials prospectively demonstrated the efficacy of the q12w/q8w (every 12 weeks/ever every 8 weeks) dosing regimen at 48 weeks, with most patients starting the q12w regimen immediately after dosing. These studies aimed to compare the efficacy and safety of intravitreal injections of brolucizumab 6 mg and 3 mg (HAWK only) compared with ablibercept 2 mg in patients with nAMD. In both trials, patients were randomized to receive either brolucizumab or abecept. After the 3-month loading phase, patients in the brolucizumab group received the q12w regimen according to the condition or the q8w regimen. Patients in the abecept group were administered every 2 months.

Previously published results showed that brolucizumab achieved a non-inferiority primary efficacy goal with a mean change in best corrected visual acuity (BCVA) from baseline to 48 weeks, with a high statistical significance compared with aboxicept. In addition, brolucizumab showed advantages in three secondary endpoints of nAMD's key indicators of disease progression: central retinal thickness, retinal fluid (retinal fluid and/or subretinal fluid), and disease activity. At the same time as these results, 57% and 52% of patients in the HAWK trial and the HARRIER trial, respectively, started the q12w regimen up to 48 weeks immediately after the dosing period.

â–² Dr. Glenn J. Jaffe, Director of Retinal Ophthalmology, Duke University (Source: Duke University Official Website)

“The ability to quickly identify patients who can maintain a 12-week dosing interval may simplify the treatment plan for nAMD patients,” said Dr. Glenn J. Jaffe, author of the retina ophthalmology at Duke University, “These data are powerful. It may be possible to provide confidence to the physician that when the 12-week dose of brolucizumab is initially successful, the patient is likely to maintain this dosing interval during the first year of treatment."

“Compared with ABC, HAWK and HARRIER previous results showed non-inferiority in primary endpoint visual acuity and superiority in several secondary endpoints for critical anatomical outcomes. Most brolucizumab patients After the dosing period, the dosing interval is maintained every 12 weeks until week 48," Dr. Dirk Sauer, Head of Ophthalmology Development at Novartis, said: "We now show that the early use of brolucizumab is a strong predictor of success in these patients. Maintaining this 12-week treatment interval up to 48 weeks. We look forward to continuing to advance brolucizumab as a welcome new option for the treatment of nAMD through regulatory approval, which is the leading cause of blindness."

Reference materials:

[1] New Novartis Phase III data for brolucizumab demonstrate reliability of 12-week treatment interval

[2] Eyeing Eylea's $5B sales, Novartis touts solid 12-week dosing data for its rival RTH258

[3] Novartis makes its case on why RTH258 can grab a blockbuster piece of Regeneron's AMD market

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