Does VUITY™ Treat AMD?

A new drug called VUITY™ (pilocarpine hydrochloride ophthalmic solution) has recently gained attention as an eye drop that can improve near (close up) vision in individuals over 40. It does not, however, change the condition of the retina. The drug, made by Allergan, works as advertised, but it should not be expected to treat age-related macular degeneration (AMD).

Vuity™ is available by prescription to treat only presbyopia. Presbyopia is common in aging eyes, resulting in stiffening of the eye’s lens and making natural focusing difficult. Reading glasses can help, but eyes with central vision loss from AMD will not benefit from either glasses or Vuity™. Vuity™ works by lessening the size of the eye’s pupil, making it easier to focus on near objects or text. This creates a kind of pinhole effect, which patients may remember as one way doctors test visual acuity. This effect may also be achieved by peering through a pinhole in an index card. 

If in doubt, patients should consult with their doctors for advice about whether Vuity™ will be appropriate for them.

Long-awaited Faricimab for wet AMD and DME approved

The FDA has approved Genentech’s Vabysmo (first announced here as faricimab), the only injectable eye medicine approved simultaneously in the U.S. for wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

Vabysmo will be administered using flexible dosing regimens based on patient need. The medication targets and inhibits two disease pathways by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), which drive the two conditions.

Vabysmo is the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses. Standard of care for wet AMD and DME typically requires eye injections every one to two months.

“Vabysmo represents an important step forward for ophthalmology,” said Charles Wykoff, M.D., Ph.D. (Director of Research, Retina Consultants of Texas in Houston and a Vabysmo Phase III investigator). “With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”

The approval is based on positive results across four Phase III studies in wet AMD and DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus Regeneron’s Eylea (aflibercept) given every two months in the first year. Vabysmo was generally well tolerated in all four studies, with a favorable benefit-risk profile.

More information and details about the research may be read here.

SOURCE: Genentech Press Release

FDA Approves First Biosimilar Drug for Treatment of Wet AMD

The U.S. Food and Drug Administration (FDA) has approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of wet AMD. Byooviz is also approved to treat macular edema and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness). The drug is administered by intravitreal injection (delivered into the vitreous humor of the eye) once a month.

Biological products (i.e. Lucentis, Eylea, and Beovu) are generally derived from living organisms and can come from many sources such as bacteria or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law. Patients can expect the same safety and effectiveness from the biosimilar over the course of treatment as from the reference product.

An important benefit of biosimilars is that they are considerably less expensive. In the case of Byooviz, the savings over Lucentis could be as much as $100 billion in the US over the next 5 years. The FDA granted approval of Byooviz to Samsung Bioepis, and other companies are expected to soon enter the market of biosimilars.

Read about all leading antiangiogenic drugs and current research

SOURCE: Press Release

FDA Approves Genentech’s Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD)

Susvimo, previously called Port Delivery System with ranibizumab, is the first wet AMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month. By continuously delivering medicine into the eye through a refillable implant, Susvimo may help people with wet AMD maintain their vision with as few as two treatments per year.

Genentech announced on October 21, 2021 that the U.S. Food and Drug Administration (FDA) approved Susvimo TM (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet (neovascular) age-related macular degeneration (AMD). The breakthrough drug delivery system is available to individuals who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Susvimo, previously called Port Delivery System with ranibizumab, is the first and only FDA-approved treatment for wet AMD that offers as few as two treatments per year.

“Susvimo represents a major advancement in the treatment of retinal disease, and is an important new option for patients with wet AMD,” said Carl Regillo, M.D., Chief of Retina Service at Wills Eye Hospital in Philadelphia and an Archway study investigator. “With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule.”

Susvimo delivers ranibizumab continuously, offering people living with wet AMD an alternative to anti-VEGF eye injections needed as often as once a month. The implant is surgically inserted into the eye during a one-time outpatient procedure and refilled every six months. If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place.

The approval is based on positive results from the Phase III Archway study primary analysis, described here in a previous post on this site.

Susvimo will be available in the United States in the coming months. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.

SOURCE: Genentech Press Release

New AMD Treatments Coming Soon

Sometimes it seems that retina research moves at a snail’s pace, but science is steadily moving toward those treatments and cures that will keep our eyes healthy. This is an update on four therapeutics just around the corner for treatment of age-related macular degeneration (AMD). Of the hundreds of ongoing clinical trials for both wet and dry AMD, these are the ones offering the most hope in the coming months.

RGX-314

Regenxbio’s RGX-314 uses a new method of inhibiting blood vessel growth (neovascularization) in wet age-related macular degeneration (wAMD). It differs from current therapeutics in that it includes a gene vector (NAV AAV8) which encodes an antibody fragment designed to neutralize VEGF (vascular endothelial growth factor) activity. As of December 31, 2020, delivery of RGX-314 was reported to be generally well-tolerated, with no evidence of inflammation. More information.

Faricimab

Roche has been studying faricimab for treatment of wet age-related macular degeneration (wAMD). The efficacy of faricimab administered at 12- and 16-week intervals was evaluated against ranibizumab (Lucentis) every 4 weeks. By January 2021, research had shown that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes as effective as those receiving Regeneron’s aflibercept (Eylea) injections every eight weeks. Roche looks forward to submitting the data to global regulatory authorities, with the aim of bringing this new treatment option as soon as possible to patients. More information.

Port Delivery System

Developed by Genentech, the Port Delivery System (PDS) is a permanent eye implant about the size of a grain of rice that continuously releases a modified version of Lucentis. Once FDA approved, patients with wet age-related macular degeneration (wAMD) would visit their doctors only twice a year to refill the device–a significantly less burdensome and costly protocol. Rollout of the PDS is expected in the U.S. in 2021 and beyond the U.S. in 2022. More information.

APL-2

Apellis reported in August 2017 that injections of APL-2 demonstrated a significant slowing of the progression of dry age-related macular degeneration (atrophic AMD). Then, in October 2020, a phase 2 analysis found that the monthly treatment reduced the rate of progression to geographic atrophy (GA) by 39 percent in areas of the retina outside of existing GA lesions. Top-line results are expected in the third quarter of 2021. More information.


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Antiangiogenic Drugs for Wet AMD

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