DME

Adrienne Scott, MD, presents a case of neovascular AMD with PED in a patient who experiences a stroke while on anti-VEGF therapy.

Expert retina specialists deliberate on their approach to treating DME, emphasizing their primary treatment choice and cases where they would use PRP laser therapy and steroids alongside anti-VEGF treatments.

Carl Danzig, MD, presents a case involving a patient with both DME and PDR, showcasing the impressive anatomic improvement achieved by treating with a dual anti-VEGF and Ang2 inhibitor.

Rishi Singh, MD, discusses the criteria for identifying patients who would benefit from biosimilar therapy.

Rishi Singh, MD, presents a case of neovascular age-related macular degeneration and diabetic macular edema demonstrating how the use of ranibizumab biosimilars can yield remarkable anatomical improvements comparable to those expected with reference biologics.

Rishi Singh, MD, provides an overview of biosimilars in the context of retinal diseases and discusses their significance within the healthcare system.

The Kingfisher Study found that the visual outcomes after 1 year of brolucizumab, 6 mg, (Beovu, Novartis) in participants with diabetic macular edema (DME) did not differ significantly from those obtained with aflibercept

Oxurion’s novel PKal Inhibitor, THR-149, did not meet its primary endpoint in the clinical trial.

Previously, the EMA had approved Eylea in a dosage of 2 mg. After considering the EMA’s recommendation, the European Commission will decide whether to issue final approval of the drug.

The Phase 3 DIAMOND trial of OCS-01 in Diabetic Macular Edema (DME) presents encouraging results, meeting primary and secondary endpoints.

Resolution of macular leakage is an early biomarker of vascular stability.

In this key role, Weil will lead the organization to commercial readiness from designing launch strategies for the US and globally.

According to the company, 4D-150 comprises its customized and evolved intravitreal vector, R100, and a transgene cassette that expresses both aflibercept and a VEGF-C inhibitory RNAi.

According to Regeneron, the approval was based on data in the PULSAR and PHOTON trials, in which the drug demonstrated clinically equivalent vision gains to aflibercept Injection 2 mg that were maintained with fewer injections.

The trial is a prospective, multi-center, open label, single-armed trial which plans on enrolling 24 eligible subjects with cystoid macular edema.

In the study, researchers found that nearly one-quarter of anti-VEGF injections were received at least 1 week later than intended.

At the 2023 ASRS meeting in Seattle, Washington, Diana Do, MD joined our team to discuss the 2-year data on the PHOTON study, which involved 8 milligrams of aflibercept for diabetic macular edema.

The company also provided an update on tarcocimab development program for the treatment of neovascular age-related macular degeneration and diabetic macular edema.

Faricimab is currently approved in more than 70 countries to treat nAMD and DME, with more than 1 million doses distributed globally, and Genentech will highlight its ophthalmology portfolio at the American Society of Retina Specialists annual meeting in Seattle.

According to Regeneron, visual gains and safety of aflibercept 8 mg remained consistent with the established profile of aflibercept 2 mg Injection.

The company announced the Complete Letter Response from the FDA for the Biologics License Application for aflibercept 8 mg is “solely due to an ongoing review of inspection findings at a third-party filler.”

Eyebiotech noted its AMARONE trial will evaluate the safety and preliminary efficacy of intravitreal EYE103.

The trial is evaluating Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for DME patients who respond suboptimally to anti-VEGF therapy.

In a Wilmer Eye Institute study, in mice and human cell models, the drug 32-134D lowered protein levels known to contribute to diabetic macular edema and diabetic retinopathy

According to the company, THR-149 is currently being evaluated in the KALAHARI Phase 2, Part B clinical trial as a potential treatment for patients who respond suboptimally to anti-VEGF, the standard of care for treatment of DME.

According to the company, AG-73305 was found to be safe and tolerable with no severe adverse effects after a single intravitreal injection of 0.5 mg and 1 mg in patients diagnosed with diabetic macular edema.

According to the company, the study has now reached its goal of 300 patients enrolled to evaluate ILUVIEN as a first line, baseline therapy for DME.

According to the company, the Phase 1 trial is a multicenter, open-label, dose-escalation safety clinical trial. Up to 24 subjects will receive a single periocular injection and will undergo monthly evaluation for up to 6 months to assess safety, tolerability, and efficacy measured by best corrected visual acuity.

According to the company, the DIAMOND trial in diabetic macular edema with topical OCS-01 met its stage 1 objective of validating the loading and maintenance dosing regimen designed to optimize OCS-01 efficacy potential with robust statistical significance.

Ophthalmology Times® talked with David Tabano, PhD, from Genentech about the company's first real-world data readouts for faricimab in the treatment of DME at this year's ARVO meeting.