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FDA issues a complete response letter to Outlook Therapeutics for ONS-5010, citing insufficient evidence of effectiveness for wet AMD treatment.

FDA issues complete response letter to Outlook Therapeutics for resubmitted BLA for ONS-5010

Advanz Pharma and Alvotech announced AVT06, a biosimilar to Eylea, was approved for neovascular age-related macular degeneration.

European Commission approves aflibercept biosimilar Mynzepli

A study reveals significant treatment burdens for patients with AMD and DME, highlighting the need for improved education and support to enhance outcomes.

An eye on how patients perceive their retinal disease

VivaVision Biotech welcomes renowned ophthalmologist Quan Dong Nguyen to its scientific advisory board with hopes of boosting innovation in ocular disease therapies.

VivaVision Biotech appoints Quan Dong Nguyen to its scientific advisory board

Catch up on recent advancements in retina care, including new therapies for age-related macular degeneration and macular telangiectasia, enhancing patient outcomes.

Navigating the most recent FDA approvals in retina

At ARVO 2025, Christine Kay, MD, shares interim results from the PRISM trial population extension cohort

At the 2025 Association for Research in Vision and Ophthalmology (ARVO) annual meeting, Christine Kay, MD, of Vitreoretinal Associates in Gainesville, Florida, shared an update from the PRISM clinical trial. Dr. Kay is a vitreoretinal surgeon and inherited retinal disease specialist. She is actively involved as an investigator in multiple clinical trials at Vitreo Retinal Associates, and presented data on behalf of 4D Molecular Therapeutics (4DMT).

"The PRISM trial is a phase 1/2 clinical trial, looking at a gene therapy for wet [neovascular] macular degeneration," Dr. Kay said. "The 4D-150 vector is designed for intravitreal injection, single delivery, and it is optimized for intravitreal injection with specific retinal tropism, meaning increased transduction to retinal cells. It's also optimized to be able to invade the vitreoretinal barricades. The 4D-150 cassette is a dual vector, dual transgene cassette encoding both aflibercept as well as a micro-mRNA sequence inhibiting VEGF-C."

Dr. Kay provided an interim update on the phase 2b population extension study, which examined patients with severe disease and more recently-diagnosed patients who had seen less progression. To learn more, watch the full video and hear Dr. Kay's full summary of the results, including her analysis of the reduction in treatment burden.

Videos

The PRISM clinical trial assesses 4D-150 (4D Molecular Therapeutics) in adults with neovascular age-related macular degeneration, also known as wet AMD.

ARVO 2025: Christine Kay, MD, shares interim results from the PRISM trial population extension cohort

Impact of Durable Therapies on Patients and Clinics and Monitoring Strategies

Video content above is prompted by the following: 

As treatments with greater durability emerge, how might they change your approach to treating neovascular age-related macular degeneration or diabetic macular edema? What impact will this have on treatment and monitoring schedules?

How will this impact workflows and clinic capacity?

Panelists discuss how longer-acting treatments will enable extended intervals between visits while requiring careful adjustment of monitoring protocols and clinic workflows to balance reduced treatment burden with maintaining adequate disease surveillance.

Video Series

Strategies for Loading Dose Sse for Treatment-Naive and Switch Patients

How strictly do you adhere to the loading dose recommendations for new therapies in treatment-naive patients with neovascular age-related macular degeneration and diabetic macular edema?

How about for patients who are switching therapies?

Panelists discuss how loading doses remain crucial for treatment-naive patients to achieve rapid disease control, while patients switching therapies may require modified approaches based on their prior treatment response and disease activity.

Perspectives on the Usefulness of Real-world Data

How do real-world data contribute to understanding the effectiveness of a therapy? What challenges arise when translating clinical trial results into real-world practice?

Panelists discuss how real-world evidence provides crucial insights into treatment effectiveness across diverse patient populations and clinical settings while highlighting challenges in maintaining clinical trial protocols’ stringent adherence and monitoring in everyday practice.

Safety Profile of New Therapies

Based on the clinical trial data, how do you view the safety profiles of faricimab and aflibercept 8 mg?

Does the long-term safety profile of aflibercept 2 mg increase your confidence in the safety of aflibercept 8 mg?

Does the increased volume of aflibercept 8 mg raise concerns about the potential for elevated intraocular pressure? How do you evaluate and address this in clinical practice?

Panelists discuss how both medications demonstrate favorable safety profiles in clinical trials, with aflibercept 8 mg benefiting from extensive 2-mg safety data, while acknowledging the need to monitor intraocular pressure due to increased injection volume, particularly in at-risk patients.

Outcomes with Raricimab and Choosing Between the New Therapies

In clinical trials, faricimab showed noninferior vision outcomes compared to aflibercept 2 mg. What added benefit do you see by targeting Ang-2?

Panelists discuss how faricimab’s dual inhibition of Ang-2 provides additional benefits in vascular stability and inflammation reduction beyond VEGF-A suppression alone, potentially leading to improved durability and treatment outcomes in selected patients.

Outcomes with Faricimab and Choosing Between the New Therapies

Faricimab Molecular Design and Role of Ang-2

What is the unique nature of the faricimab molecule, and what is the clinical rationale for targeting Ang-2 in treating retinal diseases?

Panelists discuss how faricimab’s bispecific antibody design uniquely targets both VEGF-A and Ang-2 pathways, addressing the complementary role of Ang-2 in vascular destabilization and inflammation in retinal diseases.

Patient Selection for Aflibercept 8 mg

Who is the ideal patient for aflibercept 8 mg?

Panelists discuss how ideal candidates for aflibercept 8 mg include patients with stable disease on current anti-VEGF therapy who seek reduced treatment burden, newly diagnosed patients, and those demonstrating good response to initial loading doses.

Study Design for PULSAR and PHOTON Trials for Aflibercept 8 mg

Aflibercept 8 mg was evaluated in the PULSAR and PHOTON trials for neovascular age-related macular degeneration and diabetic macular edema. Could you briefly review the design of these trials?

Panelists discuss how the phase 3 PULSAR and PHOTON trials demonstrated the efficacy of aflibercept 8 mg through a design comparing 12- and 16-week dosing intervals to the aflibercept 2 mg standard 8-week dosing, with primary end points assessing noninferiority in visual acuity maintenance.

Significance of the Higher Molar Dose of Aflibercept 8 mg

Aflibercept 8 mg was recently approved for treating age-related macular degeneration and diabetic macular edema. Could you discuss the significance of the higher molar dose?

Panelists discuss how the aflibercept 8 mg higher molecular concentration enables extended durability through increased VEGF binding capacity and longer intraocular drug levels, potentially allowing for less frequent dosing while maintaining efficacy.

Dr. Marion Munk examines the Phase 2/3 clinical trial of high-dose aflibercept (8 mg) in diabetic macular oedema.

Efficacy and Safety of Aflibercept 8 mg in PHOTON Trial in DMO

Dr. Marion Munk examines the Phase 2/3 clinical trial of high-dose aflibercept (8 mg) in diabetic macular oedema, presenting key outcomes and clinical implications of the data.

Dr. Marion Munk reviews the Phase 3 clinical trial of high-dose aflibercept (8 mg) in neovascular AMD.

Efficacy and Safety of Aflibercept 8 mg in PULSAR Trial in Neovascular AMD

Dr. Marion Munk reviews the Phase 3 clinical trial of high-dose aflibercept (8 mg) in neovascular AMD, emphasizing how this new therapy could alleviate the treatment burden for patients while providing superior outcomes.

11.	Experts conclude the series with the hope that longer-acting agents will lead to better real-world outcomes for patients.

Promoting Treatment Adherence in nAMD and DME

Experts conclude their discussion reflecting on recent therapeutic advancements and novel approaches on the horizon. As the use of longer durability agents increases, there's optimism that patient adherence to treatment will improve, potentially leading to better real-world outcomes compared to clinical trials. Educating patients about the importance of regular follow-ups and the ongoing nature of treatment is crucial for maintaining adherence. Visual aids like OCT scans can motivate patients by showing the reduction of fluid and improvement in their condition over time. Ultimately, fostering patient buy-in early on and providing ongoing support are key to maximizing treatment effectiveness and preserving vision in conditions like neovascular AMD and diabetic macular edema.

This summary was AI-generated and edited for clarity.

Experts conclude the series with the hope that longer-acting agents will lead to better real-world outcomes for patients, mirroring clinical trial results and potentially preventing vision loss, especially in countries with limited access to healthcare. 

Promoting Treatment  Adherence in nAMD and DME

Experts discusses concerns related to intraocular inflammation (IOI) and potential batch variations in biologics faricimab and aflibercept.

Safety Considerations for New Therapies 

Concerns arise with the use of new agents for neovascular AMD and DME, particularly regarding intraocular inflammation (IOI) and batch-to-batch variations inherent in biologics. The clinicians recommend closely monitoring patients for signs of IOI, vitreous cell presence, and other adverse events, especially with high-dose formulations like faricimab and aflibercept 8mg. FDA-mandated labeling changes acknowledging IOI risk reinforce safety measures, although overall risk-benefit ratios remain favorable. The transition from vials to prefilled syringes with higher volumes prompts consideration of potential complications such as increased intraocular pressure, particularly in patients with glaucoma. Techniques like ocular massage and vigilant monitoring help mitigate risks associated with higher volume injections, ensuring optimal safety for patients receiving these newer agents.

Experts discusses concerns related to the use of new agents, focusing on intraocular inflammation (IOI) and potential batch variations in biologics faricimab and aflibercept. He emphasizes close monitoring for IOI and advises clinicians to scrutinize patients for any signs of inflammation during follow-up visits. 

Safety Considerations for New Therapies

9.	Peter Kaiser, MD shares his early experiences with faricimab and high dose aflibercept for nAMD and DME.

Early Real-World Experiences With Faricimab and Aflibercept 8mg

Experts share their clinical experiences using second-generation therapeutics to manage retinal diseases. In early experiences with these drugs for neovascular AMD and DME, the feedback has been generally positive. The use of faricimab, particularly in challenging cases, has shown improvement in around one-third of patients, with another third showing similar outcomes to the previous treatment, aflibercept 2 milligram. High dose aflibercept 8mg has demonstrated efficacy in extending treatment intervals for many patients. While outcomes for the most difficult-to-treat patients are still being assessed by the experts, initial observations suggest improvement, albeit not drastically longer dosing intervals. Overall, the experts anticipate that results will align closely with those of faricimab, with roughly a third of patients experiencing significant improvement and another third seeing comparable outcomes to previous treatments.

Peter Kaiser, MD shares his early experiences with faricimab and high dose aflibercept for nAMD and DME. He notes positive outcomes, especially with hard-to-treat patients, and emphasizes the ongoing evaluation of patient response to treatment.

Peter Kaiser, MD discusses the utilization of newer agents, faricimab and high dose aflibercept.

Patient Selection for New nAMD and DME Therapies

In the provided transcript, the physicians discuss the use of newer agents, such as faricimab and high-dose aflibercept, in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). They mention that these agents were primarily tested in treatment-naive patients but are also being used in refractory patients who have not responded well to other anti-VEGF treatments. The physicians describe two main scenarios for using these agents: switching patients who are not doing well on their current treatment to a newer agent and attempting to further extend treatment intervals in patients who are responding well but still require frequent injections. They emphasize the importance of individualized treatment approaches and monitoring patient response closely. Additionally, they discuss their experiences with different treatment strategies, including switching between agents and adjusting dosing intervals, based on patient needs and response. The physicians also touch upon the safety profile of these newer agents, highlighting the need for vigilance, especially in the case of brolucizumab, and expressing confidence in the safety of faricimab and high-dose aflibercept based on clinical trial data.

Peter Kaiser, MD discusses the utilization of newer agents, faricimab and high dose aflibercept, for refractory patients who haven't responded well to previous treatments and for patients doing well but aiming to extend dosing intervals. 

Experts discuss the use of steroids, particularly in the context of diabetic macular edema (DME). 

Using Steroids in DME Treatment

Experts discuss the use of steroids in the treatment of diabetic macular edema (DME). They agree that steroids can be beneficial in DME due to its inflammatory nature, especially in patients with persistent fluid despite anti-VEGF treatment. However, they note that steroids are often added later in the treatment course in the United States compared to other countries like Italy and Japan. The physicians acknowledge the potential adverse effects of steroids, such as cataract formation and increased intraocular pressure, particularly in younger patients. Despite these risks, they emphasize the importance of considering steroids earlier in the treatment regimen for DME patients, especially in non-pseudophakic patients, as steroids can target a broader range of cytokines beyond VEGF. They both express support for the use of steroids in diabetic retinopathy or DME, while noting that steroids are not indicated for age-related macular degeneration (nAMD).

Experts discuss the use of steroids, particularly in the context of diabetic macular edema (DME). The inflammatory nature of DME reveals the effectiveness of steroids, especially in cases where persistent fluid remains despite anti-VEGF treatment. 

4.	David Eichenbaum, MD, FASRS concludes this series with the final case of a patient switching from aflibercept 2 mg to high-dose aflibercept 8 mg.

Case 2: Treatment-Experienced nAMD Switch to Aflibercept 8mg

David Eichenbaum, MD, FASRS presents the second case, wrapping up with key insights from the cases in this series. The second case involved an 88-year-old patient with neovascular macular degeneration, initially treated with aflibercept 2 mg every 5 to 6 weeks. The patient had good outcomes, but Eichenbaum sought to improve both anatomy and visit frequency. The patient was switched from aflibercept 2 mg to aflibercept 8 mg. After the first injection, there was a notable improvement in anatomy and visual acuity. Subsequently, the patient was extended to an 8-week interval, showcasing positive outcomes.

Regarding the choice between aflibercept 8 milligrams and faricimab, Eichenbaum finds it challenging, expressing that both are excellent drugs. He hopes for clearer guidance on which patients may benefit more from one over the other. In his practice, that decision often relies on individual patient response to treatment.

This summary was AI-generated and edited for clarity. 

David Eichenbaum, MD, FASRS concludes this series with the final case of a treatment-experienced patient switching from aflibercept 2 mg to high-dose aflibercept 8 mg with noticeable improvement after the first dose. 

3.	David Eichenbaum, MD, FASRS provides his clinical experience with faricimab and aflibercept 8 mg.

Clinical Perspectives Comparing Faricimab and Aflibercept 8mg

David Eichenbaum, MD, FASRS reflects on his experience with faricimab and aflibercept 8 mg, noting that both second-generation agents have shown superiority over first-generation agents like ranibizumab and aflibercept 2 mg. While he acknowledges these advancements as significant, he characterizes them as incremental rather than revolutionary. He emphasizes the importance of these drugs in optimizing care for patients with macular degeneration, particularly in terms of anatomic response and durability, while highlighting the quality-of-life improvements for patients who require frequent care and doctor visits. Eichenbaum believes that these drugs demonstrate differences in both drying ability and durability compared to their predecessors.

He stresses the relevance of real-world experience, especially with treatment-experienced patients who may have different needs than those in registration studies. Overall, he sees these second-generation agents as essential tools for optimizing the treatment of macular degeneration patients.

David Eichenbaum, MD, FASRS provides his clinical experience with faricimab and aflibercept 8 mg, highlighting the small and large changes that benefit a patient’s quality of life, such as improved visual anatomy or reducing the frequency of visits. 

 Kaiser, MD explains that loading doses may not be necessary based on studies like the CAT study.

Perspectives on Loading Dose and Treatment Extension With New Therapies

The retinal specialists discuss the use of loading doses in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). They share insights from studies indicating that a loading dose may not significantly impact visual acuity outcomes, referencing the CAT study as an example. The physicians emphasize individualized treatment approaches, such as treating to dryness and using a treat-and-extend regimen based on patient response rather than fixed dosing intervals. They discuss extending treatment intervals based on patient response and the specific characteristics of each disease, highlighting the importance of flexibility and considering patient preferences in treatment decisions. Additionally, they note the complexity of managing these conditions and the need for careful consideration beyond simply administering injections.

Experts discuss the approach to loading doses in the context nAMD and DME. Kaiser, MD explains that loading doses may not be necessary based on studies like the CAT study, while he highlights the importance of individualized treatment plans tailored to the specific needs of each patient and the nuances of different retinal diseases. 

AMD

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