FDA Approved Treatments For Macular Degeneration

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fda approved treatment for macular degeneration

SYFOVRE blocks C3, a protein from the complement system that contributes to abnormal blood vessel formation in wet AMD. This treatment may preserve vision in people suffering from geographic atrophy (GA), which damages central parts of retina known as fovea.

Implant therapy allows patients to benefit from anti-VEGF therapy in a similar fashion as injections; additionally, this approach reduces office visits and treatment sessions significantly.

Visudyne

VISUDYNE is the first drug therapy approved to stop leaky blood vessels caused by wet age-related macular degeneration, an eye disease which can result in severe vision loss if untreated. Therefore, it is vital that when taking VISUDYNE you follow all instructions and safety precautions as recommended by your healthcare provider.

This treatment combines Visudyne injection and laser light therapy. Your doctor will inject Visudyne into your arm, then use laser light therapy on your eye to activate it. This causes a chemical reaction which destroys abnormal blood vessels in your eye and may improve vision – all non-invasively at your doctor’s office.

Contrary to conventional treatments that require regular injections, this implant-delivered drug has been shown to be both safe and effective during multiple clinical trials. It works by inhibiting blood vessel growth that forms beneath the retina as well as decreasing fluid accumulation that leads to scar tissue formation that could ultimately result in vision loss – providing a welcome respite for people living with wet AMD, the most dangerous form of AMD.

Hopes were high that this treatment would prove more cost-effective than current therapies; however, the PBAC denied their request to list it for patients suffering from subfoveal choroidal neovascularization due to macular degeneration and pathological myopia, or presumed Ocular Histoplasmosis Syndrome (POHS). Furthermore, they expressed concern over an unacceptable incremental cost per quality adjusted life year gained exceeding $200,000.

Novartis’ Bevacizumab is a monoclonal antibody developed to treat wet age-related macular degeneration. Approved by the Food and Drug Administration for use by adults living with wet macular degeneration, its powerful treatments may allow patients to improve their vision faster with less injections or treatment sessions than with traditional drugs.

Apellis Pharmaceuticals recently received FDA approval for Izervay, an intravitreal injection which inhibits complement C5. Complement proteins play a vital role in scar tissue formation and retinal tears, known as geographic atrophy (GA), which affects 1.5 million Americans. Izervay inhibits complement C5 proteins through intravitreal injection to help slow or stop vision loss from age-related macular degeneration due to GA.

Aflibercept

Eylea (aflibercept) was recently approved by the Food and Drug Administration as a treatment for neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion or diabetic macular edema (DME). This drug works by blocking vascular endothelial growth factor to stop new blood vessels from growing while decreasing fluid buildup in the eye. Eylea must be injected intravitreally via an aseptic injection technique in order to prevent complications like endophthalmitis or retinal detachment.

Approval was granted based on results of two Phase III clinical trials, PULSAR for wet AMD and PHOTON for DME, that compared the drug with laser therapy for improving best corrected visual acuity improvement; both trials also included predetermined secondary endpoints such as diabetic retinopathy grading.

According to its manufacturer, Aflibercept is designed to block two growth factors involved in angiogenesis – VEGF-A and PLGF. This blocks new blood vessel formation in retina while decreasing fluid leakage from existing ones resulting in decreased amounts of fluid accumulation within eyes and improved vision. A 2 mg dose comes packaged in a sterilized prefilled syringe for easy use.

Studies determined that the drug was safe and well tolerated among patients with neovascular AMD. Treatment-emergent adverse events occurred similarly among all groups; no differences were seen in terms of serious ocular or non-ocular side effects between treatments; also, anti-Platelet Trialists’ Collaboration events occurred similarly for both treatments.

Regeneron Pharmaceuticals Inc markets this drug in the US; it comes as a 2mg injection that comes prefilled in one pre-filled syringe and should be administered intravitreally. Furthermore, this medicine is available as prescription medication in Europe and Canada.

Aflibercept is an intravitreal injection used to treat age-related macular edema or wet macular degeneration, one of the leading causes of blindness among older people. The medicine works by inhibiting vascular endothelial proliferation factor which promotes new blood vessel formation in the retina. Aflibercept received approval in November 2011.

Susvimo

Susvimo is a refillable intraocular implant designed to deliver ranibizumab on an ongoing basis, treating wet age-related macular degeneration, diabetic macular edema (DME), retinal vascular conditions and other retinal diseases. The implant can be surgically placed into your eye using an approach similar to cataract removal surgery.

Implants for treating anti-VEGF have been clinically proven safe and effective, as evidenced by multiple clinical trials. Furthermore, they reduce treatment frequency compared to anti-VEGF injections given monthly; however they have yet to receive approval in the US; Genentech plans on filing an application later this year to obtain new indications for their drug.

According to an FDA statement, Susvimo can drastically decrease the frequency of annual treatments for wet AMD patients compared to monthly injections. As the first of its kind ocular implant available today, Susvimo may require as few as two visits annually and works by blocking pathways involving angiogenic growth factor-A (VEGF-A) and angiopoietin-2 (Ang-2). These disease mechanisms are believed to cause sight-threatening retinal neovascularization and fluid leakage from retinal eye cells into retinal retinal eye retinal eyesight.

Susvimo, like other VEGF inhibitors, is known to stabilize blood vessels and prevent fluid leakage into the retina. Its effectiveness was demonstrated in the Archway study comparing Susvimo to monthly ranibizumab injections among people living with neovascular wet AMD; after two years on Susvimo patients saw comparable best-corrected visual acuity gains compared with monthly injections.

Roche acknowledges the benefits of its new treatment are clear; however, it will be challenging for them to convince patients to go through with surgery to receive an implant that requires refilling every six months and may cause severe infections in some of its clinical trials participants.

Roche has achieved an important milestone with this announcement of a new implant for anti-VEGF injection; however, its approval in the United States and Europe depends on successful commercialization. For this to occur, they must overcome stigmatized therapies like implants by assuring doctors it is a safe alternative to injections as well as demonstrate compatibility with existing anti-VEGF medications like ranibizumab which already holds FDA approval for anti-VEGF use.

VABYSMO

VABYSMO (faricimab-svoa) was granted FDA approval in January 2022 for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME). It works by blocking vascular endothelial growth factor which promotes leakage and angiogenesis, and neutralizing angiopoietin-2 which contributes to fluid leakage.

Drug is administered intravitreally using an intravitreal delivery system. Studies using the drug showed it improved visual acuity and anatomical stability across three studies – including two randomized, double-blind clinical trials – while being well tolerated overall. Unfortunately, more serious side effects such as conjunctival hemorrhage or increased eye blood pressure occurred occasionally with its use.

Genentech recently unveiled an aggressive Phase III clinical development program for Vabysmo. This includes two extension studies: AVONELLE-X is designed to measure long-term safety and tolerability; RHONE-X expands on YOSEMITE/RHINE studies by testing efficacy against wet AMD/DME patients; while Macular Edema Due to Retinal Vein Occlusion (RVO) patients will also be studied using Vabysmo as part of this effort.

VABYSMO targets angiopoietin-2, a protein responsible for fluid leakage and inflammation as well as angiogenesis, while simultaneously blocking VEGF. In clinical trials, VABYSMO demonstrated sustained vision gains for more than a year after an initial loading phase consisting of four monthly injections; this represents significant clinical benefit according to its manufacturer.

VABYSMO was granted approval based on the results of global phase 3 BALATON and COMINO studies. These trials demonstrated that monthly injections of VABYSMO were noninferior to aflibercept for treating macular edema in patients with branch and central retinal vein occlusion; more patients receiving VABYSMO had no fluid accumulation compared with those taking aflibercept, making these findings highly significant advances in retinal vascular disease treatments and the first time macular edema treatment has been proven able to prevent further vision loss in RVO patients.

About the Author:
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Alexander Suprun

Alex started his first web marketing campaign in 1997 and continues harvesting this fruitful field today. He helped many startups and well-established companies to grow to the next level by applying innovative inbound marketing strategies. For the past 26 years, Alex has served over a hundred clients worldwide in all aspects of digital marketing and communications. Additionally, Alex is an expert researcher in healthcare, vision, macular degeneration, natural therapy, and microcurrent devices. His passion lies in developing medical devices to combat various ailments, showcasing his commitment to innovation in healthcare.

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