Gold Injections in The Eye May Be The Future of Vision Preservation
Macular degeneration affects millions worldwide and becomes more likely as we age. Damage to the macula, located in the retina and containing light-sensitive photoreceptor cells, causes blurring and other vision issues. While there are treatments available to slow the progression of AMD, they don't reverse it.
"This is a new type of retinal prosthesis that has the potential to restore vision lost to retinal degeneration without requiring any kind of complicated surgery or genetic modification," says biomedical engineer Jiarui Nie, from Brown University in Rhode Island.
"We believe this technique could potentially transform treatment paradigms for retinal degenerative conditions."
Here's how the new treatment works: very fine gold nanoparticles, thousands of times thinner than a human hair, are laced with antibodies to target specific eye cells. They're then injected into the gel-filled vitreous chamber between the retina and the lens.
Next, a small infrared laser device is used to excite these nanoparticles and activate specific cells in the same way photoreceptors do. If the treatment makes it to us humans as well, that laser could be embedded in a pair of glasses.
In the mice this was tested on, engineered to have retinal disorders, the treatment method was effective at restoring vision, at least partly (it's tricky to give a mouse a full eye test). It showed the nanoparticles could help bypass damaged photoreceptors.
"We showed that the nanoparticles can stay in the retina for months with no major toxicity," says Nie.
"And we showed that they can successfully stimulate the visual system. That's very encouraging for future applications."
The approach has similarities to existing treatments for AMD and related conditions such as retinitis pigmentosa. However, this new method is less invasive, with no surgery or large implants inside the eye needed, and also promises to cover a wider field of vision.
As with most studies in mice, there's a good chance the findings will translate over to humans, but it'll take a while to get there – and to get something safe that can be approved for use. This is an important first step.
An increasing number of studies are presenting ways in which eye diseases could be tackled by the latest technology and science, including reprogramming other retinal cells to replace photoreceptors that are no longer working.
"This innovation marks a significant breakthrough, setting the stage for future development of photothermal retinal prostheses such as wearable goggles," write the researchers in their published paper.
"For future human applications, further refinement is necessary."
The research has been published in ACS Nano.
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Yahoo
3 days ago
- Yahoo
Genentech's Susvimo Maintains Vision Over Five Years With Two Refills Per Year in People With Wet Age-Related Macular Degeneration (AMD)
– Susvimo is the only continuous delivery treatment to provide reliable, long-term vision outcomes in wet AMD, the leading cause of vision loss in people over the age of 60 – – With two refills per year, Susvimo maintained vision and stabilized the retina for five years, with durability maintained in approximately 95% of patients – – Susvimo was well tolerated over five years and has a well-characterized safety profile – SOUTH SAN FRANCISCO, Calif., August 01, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new, five-year efficacy, safety and durability data from the Phase III Portal study, a long-term extension of the Phase III Archway study, of Susvimo® (ranibizumab injection) for the treatment of people with wet AMD. Results show that Susvimo's immediate and predictable durability was sustained over five years, with approximately 95% of people receiving treatment every six months requiring no supplemental treatment before each refill. The data were presented at the American Society of Retina Specialists (ASRS) 2025 Annual Meeting in Long Beach, California. "These long-term results reinforce Susvimo's ability to maintain vision and retinal drying over a long period of time for people with wet AMD, the leading cause of vision loss in people over age 60," said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. "These robust data reinforce our confidence in Susvimo's unique therapeutic approach, providing an effective alternative to regular eye injections while preserving vision in a sustained manner." "People with wet AMD often experience suboptimal outcomes with real-world anti-VEGF treatment, largely due to the frequency of injections," said study investigator John Kitchens, M.D., Retina Associates of Kentucky, who presented the data at ASRS. "Continuous delivery of treatment with Susvimo may preserve vision in patients with wet AMD for longer in real-world clinical use than IVT injections." In the Portal study (n = 352), people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort; n = 220), while those originally treated with monthly intravitreal (IVT) ranibizumab injections in Archway received Susvimo and then refills every six months (IVT-Susvimo cohort; n = 132). Five-year results showed consistent and sustained disease control and retinal drying in a population who entered Archway with vision at or near peak levels after receiving an average of five intravitreal injections per standard of care. In the Susvimo cohort, best-corrected visual acuity (BCVA) was 74.4 letters at baseline and 67.6 letters at 5 years. In the IVT-Susvimo cohort, BCVA was 76.3 letters at baseline and 68.6 at 5 years. Half of all patients had better than 20/40 vision at five years (Snellen visual acuity test). Average central subfield thickness (CST) remained stable, with a 1.0 (95% CI: -13.1, 11.1) µm reduction from baseline in the Susvimo cohort, and a 10.3 (95% CI: -25.7, 5.0) µm reduction in the IVT-Susvimo cohort. The cohort of people who entered the Portal study from Archway is the largest cohort of people with wet AMD to be followed prospectively and continuously for five years in a clinical study. Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss. About the Archway study and its open-label extension study (Portal) Archway (NCT03677934) was a randomized, multicenter, open-label Phase III study evaluating the efficacy and safety of Susvimo refilled every six months at fixed intervals, compared to monthly IVT ranibizumab 0.5 mg in 415 people living with wet AMD. Patients were randomized 3:2 to Susvimo (n = 248) or intravitreal (IVT) ranibizumab injections (n = 167). Patients enrolled in Archway were responders to prior treatment with anti-VEGF therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit, with an average of five anti-VEGF injections before randomization. The primary endpoint of the study was the change in BCVA score from baseline at the average of Week 36 and Week 40. Secondary endpoints include safety, overall change in vision (BCVA) from baseline and change from baseline in center point thickness over time. Patients who completed the study at week 96 were eligible to enter the Portal open-label extension study. In Portal, people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort), while those originally treated with monthly IVT ranibizumab injections in Archway received the Susvimo implant and then refills every six months (IVT-Susvimo cohort). Portal is ongoing. About Wet Age-Related Macular Degeneration (AMD) Age-related macular degeneration (AMD) is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading. It is a leading cause of blindness for people aged 60 and over in the U.S. Wet, or neovascular, AMD is an advanced form of the disease that can cause rapid and severe vision loss. Approximately 20 million people in the U.S. have some form of AMD, and of those, about 1.5 million have late-stage AMD, which includes wet AMD. Wet AMD is caused by growth of abnormal blood vessels, also referred to as choroidal neovascularization (CNV), into the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This process results in a deterioration of sight over a period of months to years. Genentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or Visit for additional information. About Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time. Susvimo is indicated for intravitreal use via the Susvimo eye implant only. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels. Susvimo was previously called the Port Delivery System with ranibizumab in the U.S. The customized formulation of ranibizumab delivered by Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis® (ranibizumab injection), which is approved to treat wet, or neovascular, age-related macular degeneration (AMD) and other retinal diseases. Lucentis was first approved for wet AMD by the FDA in 2006. Susvimo Indication Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR) who have previously responded to at least two intravitreal injections of a vascular endothelial growth factor inhibitor medication. Susvimo Important Safety Information WARNING: ENDOPHTHALMITISThe Susvimo implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Warnings and Precautions:The Susvimo implant and the procedures associated with inserting, filling, refilling, and (if medically necessary) removing the implant can cause other serious side effects, including: An eye infection (endophthalmitis). Endophthalmitis is an infection of the eyeball that can cause permanent damage to your eye, including blindness. Endophthalmitis requires urgent (same-day) medical or surgical treatment. A missing layer on top of the white part of the eye (conjunctival erosion). Conjunctival erosion is an area that becomes missing (defect) in the layer (conjunctiva) that covers the white part of the eye, which may result in exposure of the implant. Conjunctival erosion may require surgical treatment. An opening of the layer that covers the white part of the eye (conjunctival retraction). Conjunctival retraction is an opening or gaping in the layer (conjunctiva) that covers the white part of the eye, which may cause the implant to be exposed. Conjunctival retraction may require surgical treatment. Tear and separation of layers of the retina (rhegmatogenous retinal detachment). Rhegmatogenous retinal detachment is a tear and separation of one of the layers of the retina in the back of the eye that senses light. Rhegmatogenous retinal detachment requires surgical treatment. Implant movement (implant dislocation): This movement may require surgical treatment to correct. Implant damage: Damage to the implant that prevents continued treatment (refills) with Susvimo. If the implant is not able to be properly refilled, a patient's wet AMD may be inadequately treated and a physician may remove the implant and/or change the treatment. Bleeding (vitreous hemorrhage): Vitreous hemorrhage is bleeding within the gel-like substance (vitreous) inside of your eye. This may require an additional eye surgery. Bump on top of the white layer of the eye (conjunctival bleb): Conjunctival bleb is a small bulge in the layer (conjunctiva) that covers the white part of the eye where the implant is inserted. This may be due to leakage of fluid from the inside of the eye. This may require medical or surgical treatment. Temporary decrease in vision after the Susvimo procedure. Who should not receive Susvimo? Patients who have an infection in or around their eye, have active inflammation in their eye, or have had an allergic reaction to ranibizumab or any of its ingredients in Susvimo in the past. Information for patients who are of childbearing potential If patients are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if Susvimo will harm an unborn baby. Patients should use birth control (contraception) during treatment with Susvimo and for 12 months after the last refill of Susvimo. If patients are breastfeeding or plan to breastfeed. Susvimo is not recommended during breastfeeding. It is not known if Susvimo passes into breast milk. Adverse Reactions The most common adverse reactions were blood on the white of the eye, redness in the white of the eye, sensitivity to light, and eye pain. These are not all the possible side effects of Susvimo. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see additional Important Safety Information in the full Susvimo Prescribing Information, including BOXED WARNING or visit About Lucentis® (ranibizumab injection) Lucentis® is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV). Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. Outside the United States, Lucentis is approved in more than 120 countries to treat adult patients with wet AMD, and for the treatment of visual impairment due to DME, due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), and due to choroidal neovascularization (CNV). Lucentis Important Safety Information Lucentis is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in Lucentis. Hypersensitivity reactions may manifest as severe intraocular inflammation. Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Increases in intraocular pressure have been noted both pre-injection and post-injection with Lucentis. Although there was a low rate of arterial thromboembolic events (ATEs) observed in the Lucentis clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with Lucentis compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded. Retinal vasculitis and/or retinal vascular occlusion have been reported. Patients should be instructed to report any change in vision without delay. In the Lucentis Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. For additional safety information, please see Lucentis full Prescribing Information, available here: About Genentech in Ophthalmology Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases, including rare and inherited conditions. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit View source version on Contacts Media Contact:Nicole Burkart (650) 467-6800Advocacy Contact:Meg Harrison (617) 694-7060Investor Contacts:Loren Kalm (650) 225-3217Bruno Eschli +41 61 687 5284 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
3 days ago
- Business Wire
Genentech's Susvimo Maintains Vision Over Five Years With Two Refills Per Year in People With Wet Age-Related Macular Degeneration (AMD)
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new, five-year efficacy, safety and durability data from the Phase III Portal study, a long-term extension of the Phase III Archway study, of Susvimo ® (ranibizumab injection) for the treatment of people with wet AMD. Results show that Susvimo's immediate and predictable durability was sustained over five years, with approximately 95% of people receiving treatment every six months requiring no supplemental treatment before each refill. The data were presented at the American Society of Retina Specialists (ASRS) 2025 Annual Meeting in Long Beach, California. 'These long-term results reinforce Susvimo's ability to maintain vision and retinal drying over a long period of time for people with wet AMD, the leading cause of vision loss in people over age 60,' said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. 'These robust data reinforce our confidence in Susvimo's unique therapeutic approach, providing an effective alternative to regular eye injections while preserving vision in a sustained manner.' 'People with wet AMD often experience suboptimal outcomes with real-world anti-VEGF treatment, largely due to the frequency of injections,' said study investigator John Kitchens, M.D., Retina Associates of Kentucky, who presented the data at ASRS. 'Continuous delivery of treatment with Susvimo may preserve vision in patients with wet AMD for longer in real-world clinical use than IVT injections.' In the Portal study (n = 352), people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort; n = 220), while those originally treated with monthly intravitreal (IVT) ranibizumab injections in Archway received Susvimo and then refills every six months (IVT-Susvimo cohort; n = 132). Five-year results showed consistent and sustained disease control and retinal drying in a population who entered Archway with vision at or near peak levels after receiving an average of five intravitreal injections per standard of care. In the Susvimo cohort, best-corrected visual acuity (BCVA) was 74.4 letters at baseline and 67.6 letters at 5 years. In the IVT-Susvimo cohort, BCVA was 76.3 letters at baseline and 68.6 at 5 years. Half of all patients had better than 20/40 vision at five years (Snellen visual acuity test). Average central subfield thickness (CST) remained stable, with a 1.0 (95% CI: -13.1, 11.1) µm reduction from baseline in the Susvimo cohort, and a 10.3 (95% CI: -25.7, 5.0) µm reduction in the IVT-Susvimo cohort. The cohort of people who entered the Portal study from Archway is the largest cohort of people with wet AMD to be followed prospectively and continuously for five years in a clinical study. Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss. About the Archway study and its open-label extension study (Portal) Archway (NCT03677934) was a randomized, multicenter, open-label Phase III study evaluating the efficacy and safety of Susvimo refilled every six months at fixed intervals, compared to monthly IVT ranibizumab 0.5 mg in 415 people living with wet AMD. Patients were randomized 3:2 to Susvimo (n = 248) or intravitreal (IVT) ranibizumab injections (n = 167). Patients enrolled in Archway were responders to prior treatment with anti-VEGF therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit, with an average of five anti-VEGF injections before randomization. The primary endpoint of the study was the change in BCVA score from baseline at the average of Week 36 and Week 40. Secondary endpoints include safety, overall change in vision (BCVA) from baseline and change from baseline in center point thickness over time. Patients who completed the study at week 96 were eligible to enter the Portal open-label extension study. In Portal, people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort), while those originally treated with monthly IVT ranibizumab injections in Archway received the Susvimo implant and then refills every six months (IVT-Susvimo cohort). Portal is ongoing. About Wet Age-Related Macular Degeneration (AMD) Age-related macular degeneration (AMD) is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading. It is a leading cause of blindness for people aged 60 and over in the U.S. Wet, or neovascular, AMD is an advanced form of the disease that can cause rapid and severe vision loss. Approximately 20 million people in the U.S. have some form of AMD, and of those, about 1.5 million have late-stage AMD, which includes wet AMD. Wet AMD is caused by growth of abnormal blood vessels, also referred to as choroidal neovascularization (CNV), into the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This process results in a deterioration of sight over a period of months to years. Genentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or Visit for additional information. Susvimo ® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customized formulation of ranibizumab over time. Susvimo is indicated for intravitreal use via the Susvimo eye implant only. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels. Susvimo was previously called the Port Delivery System with ranibizumab in the U.S. The customized formulation of ranibizumab delivered by Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis ® (ranibizumab injection), which is approved to treat wet, or neovascular, age-related macular degeneration (AMD) and other retinal diseases. Lucentis was first approved for wet AMD by the FDA in 2006. Susvimo Indication Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR) who have previously responded to at least two intravitreal injections of a vascular endothelial growth factor inhibitor medication. Susvimo Important Safety Information WARNING: ENDOPHTHALMITIS The Susvimo implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Warnings and Precautions: The Susvimo implant and the procedures associated with inserting, filling, refilling, and (if medically necessary) removing the implant can cause other serious side effects, including: An eye infection (endophthalmitis). Endophthalmitis is an infection of the eyeball that can cause permanent damage to your eye, including blindness. Endophthalmitis requires urgent (same-day) medical or surgical treatment. A missing layer on top of the white part of the eye (conjunctival erosion). Conjunctival erosion is an area that becomes missing (defect) in the layer (conjunctiva) that covers the white part of the eye, which may result in exposure of the implant. Conjunctival erosion may require surgical treatment. An opening of the layer that covers the white part of the eye (conjunctival retraction). Conjunctival retraction is an opening or gaping in the layer (conjunctiva) that covers the white part of the eye, which may cause the implant to be exposed. Conjunctival retraction may require surgical treatment. Tear and separation of layers of the retina (rhegmatogenous retinal detachment). Rhegmatogenous retinal detachment is a tear and separation of one of the layers of the retina in the back of the eye that senses light. Rhegmatogenous retinal detachment requires surgical treatment. Implant movement (implant dislocation): This movement may require surgical treatment to correct. Implant damage: Damage to the implant that prevents continued treatment (refills) with Susvimo. If the implant is not able to be properly refilled, a patient's wet AMD may be inadequately treated and a physician may remove the implant and/or change the treatment. Bleeding (vitreous hemorrhage): Vitreous hemorrhage is bleeding within the gel-like substance (vitreous) inside of your eye. This may require an additional eye surgery. Bump on top of the white layer of the eye (conjunctival bleb): Conjunctival bleb is a small bulge in the layer (conjunctiva) that covers the white part of the eye where the implant is inserted. This may be due to leakage of fluid from the inside of the eye. This may require medical or surgical treatment. Temporary decrease in vision after the Susvimo procedure. Who should not receive Susvimo? Patients who have an infection in or around their eye, have active inflammation in their eye, or have had an allergic reaction to ranibizumab or any of its ingredients in Susvimo in the past. Information for patients who are of childbearing potential If patients are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if Susvimo will harm an unborn baby. Patients should use birth control (contraception) during treatment with Susvimo and for 12 months after the last refill of Susvimo. If patients are breastfeeding or plan to breastfeed. Susvimo is not recommended during breastfeeding. It is not known if Susvimo passes into breast milk. Adverse Reactions The most common adverse reactions were blood on the white of the eye, redness in the white of the eye, sensitivity to light, and eye pain. These are not all the possible side effects of Susvimo. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see additional Important Safety Information in the full Susvimo Prescribing Information, including BOXED WARNING or visit About Lucentis ® (ranibizumab injection) Lucentis ® is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV). Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. Outside the United States, Lucentis is approved in more than 120 countries to treat adult patients with wet AMD, and for the treatment of visual impairment due to DME, due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), and due to choroidal neovascularization (CNV). Lucentis Important Safety Information Lucentis is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in Lucentis. Hypersensitivity reactions may manifest as severe intraocular inflammation. Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Increases in intraocular pressure have been noted both pre-injection and post-injection with Lucentis. Although there was a low rate of arterial thromboembolic events (ATEs) observed in the Lucentis clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with Lucentis compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded. Retinal vasculitis and/or retinal vascular occlusion have been reported. Patients should be instructed to report any change in vision without delay. In the Lucentis Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. For additional safety information, please see Lucentis full Prescribing Information, available here: About Genentech in Ophthalmology Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases, including rare and inherited conditions. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit
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4 days ago
- CNN
Covid-19 vaccine policy changes raise questions and concerns for US adults as summer wave ramps up
Vaccines Respiratory viruses Children's healthFacebookTweetLink Follow As Covid-19 transmission ramps up in the United States, recent changes to federal vaccine guidance have left many Americans confused about the latest policies and concerned about access to shots this fall. The US has had a summer surge in Covid-19 cases each year since the pandemic began. This year, however, experts say that the seasonal wave is starting later than anticipated and is relatively subdued. Surveillance data from WastewaterSCAN shows that median Covid-19 concentrations ticked up from June to July, with high levels in some parts of the country, but overall, it's far below this time last year. 'My hypothesis was that the weak winter wave would set the stage for a bigger summer, because many people would not have recent immunity. So far, activity has been more sedate than I anticipated,' epidemiologist Caitlin Rivers wrote in her newsletter Sunday. 'I remain open-minded about what August will bring. My best guess is continued increases until early September, but I am uncertain.' Although it's too early to know how big the current uptick will be or how long it will last, Dr. Jennifer Nuzzo, an epidemiologist and director of the Pandemic Center at the Brown University School of Public Health, says her key concern is whether Covid-19 vaccines will be available 'in time to protect people, especially those at high risk, against severe illness.' 'My biggest worry at this point is the uncertainty about when updated Covid vaccines will become available and who will be able to get them,' Nuzzo said. New survey data from KFF published Friday shows that most adults in the US don't plan to get a Covid-19 vaccine this fall, but most who do plan to get the shot share concerns that the vaccine won't be available to them and that their insurance won't cover the cost. In the past few months, US Department of Health and Human Services Secretary Robert F. Kennedy Jr. has said that the Covid-19 shot will no longer be recommended for healthy children and pregnant women, replaced a federal vaccine advisory panel and announced plans to examine the well-established federal childhood vaccine schedule. For the latest survey, KFF polled a nationally representative sample of nearly 1,300 adults between July 8 and 14 – at least two weeks after each of these events. About a quarter of US adults say Kennedy has made 'major' changes to vaccine policy in the US, but another 40% 'don't know enough to say,' the KFF poll found. Of those who do plan to get a Covid-19 vaccine this fall – more likely to be older adults and Democrats – about two-thirds say they are concerned that it might not be available to them. And more than 60% of insured adults who plan to get the shot are worried that their insurance won't cover it. About half of parents are not sure whether federal health agencies are currently recommending that healthy children receive a Covid-19 vaccine this fall, according to the new KFF data. Kennedy announced that the US Centers for Disease Control and Prevention will not formally recommend the Covid-19 vaccine for healthy children, leaving decisions to be made between parents and their health care provider. KFF found that personal doctors or health care providers remain the most trusted source for information about vaccines, with 8 in 10 adults saying they trust their own doctor at least 'a fair amount.' Trust in local health departments and the CDC has been eroding over the past two years, but most adults still say they trust these sources for vaccine information. But far fewer – only 37% of adults – say they trust Kennedy at least 'a fair amount' to provide information on vaccines, according to KFF. When asked about the impact of the changes to federal vaccine policy, more than a third of adults said they are making people less safe. Only 1 in 5 said the changes are making people safer. Rivers says she recommends that people who want their annual Covid-19 get it sooner rather than later. 'The big drawback is, it is not updated yet; the new formulation will be released closer to autumn,' she said, but getting a shot now will offer protection against the unpredictable summer wave and get ahead of access concerns that may arise in the future.
