Home monitoring systems, longer-acting drugs should ease burden of retinal disease

Innovative technologies have shown promising results in studies.

New longer-acting molecules and home monitoring will soon help relieve the increasing burden of age-related macular degeneration and diabetes-related ocular pathologies, both in patients and on public health delivery, according to one specialist.

“The number of patients who suffer from AMD is significantly on the increase due to the aging of the population. We are going to deal with more than 1 billion patients in the next decade, a big issue of public health,” Anat Loewenstein, MD, MHA, said in an interview with Ocular Surgery News.

The first priority is large-scale screening to detect people with the disease. Second is the detection of patients who convert from non-neovascular to neovascular disease. In the U.S. only, conversion to neovascular AMD occurs in as many as 2,000 cases per year, and often patients present to be examined too late, Loewenstein said. Once choroidal neovascularization has been detected, the next issue from a public health perspective is to monitor and manage the cases.

Anat Loewenstein, MD, MHA
Anat Loewenstein

“Prompt detection of disease recurrence is critical to the overall success of treatment,” she said.

Diabetes is growing to epidemic proportions in the Western world, mainly due to increased obesity rates. Screening is again the first critical step to detect patients with diabetes and, among them, those who develop diabetic retinopathy.

“We know that, over the years, most of the patients with diabetes will develop DR, so we need to screen large populations of diabetic patients for DR and diabetic macular edema. Once we identify them, the next major goal in public health is again monitoring and treating. In order to replicate in real life the good visual acuity results achieved in trials, we need to see our patients very often, find out when they have fluid and treat them promptly,” Loewenstein said.

Home monitoring OCT systems

Home monitoring systems may be an effective way to monitor patients regularly, reducing the burden of multiple visits for individuals and health care systems alike.

“I am involved in home-based monitoring with the Notal Vision OCT system, still a prototype for now. We have performed a large study involving two centers in Israel and two centers in America that included 350 eyes and were able to show that 90% of the people, even though they are old, up to 99 years of age, are able to self-operate the OCT and produce gradable images. These images were compared to those of two commercial OCTs, the Heidelberg Spectralis and the Zeiss Cirrus, showing a sensitivity and specificity for fluid detection of more than 90% with beautiful images. This device was already granted approval by the FDA, and we are concluding more studies in this regard,” Loewenstein said.

Longer-acting drugs

Longer-acting drugs are another way of reducing the burden on patients and health care systems.

In October, the FDA approved Beovu (brolucizumab-dbll, Novartis) for the treatment of wet AMD on a 3-month dosing interval after a 3-month loading phase.

“Brolucizumab is administered by intravitreal injection every 3 months and seems to consistently dry retinal fluid even better than aflibercept.” Loewenstein said.

Phase 3 study results for abicipar pegol (Allergan) have demonstrated 8- and 12-week dosing regimens to be comparable to monthly treatment with Lucentis (ranibizumab, Genentech) for treatment of neovascular AMD. Two-year results presented at the American Academy of Ophthalmology annual meeting showed visual acuity gains were maintained with the longer dosing intervals.

Early results of the phase 3 studies raised concern over the high rate of intraocular inflammation resulting from the treatment. However, “The MAPLE study performed in Canada used a modified formulation that seems to have reduced the rate of inflammation by half,” Loewenstein said.

A third drug, faricimab (Genentech/Roche), is a molecule with bispecific action on VEGF and angiopoietin-2.

“Phase 2 results for AMD and DME show potential for longer duration, up to 3 months or even 16 weeks, and it is as good as ranibizumab monthly,” Loewenstein said.

Other molecules are under investigation at less advanced stages, including an injection of anti-VEGF in a viral vector to be delivered under the retina for sustained release of the drug.

“Patients will be able to come less often and will need fewer injections, and we will be able to monitor them at home. This will significantly ease health system pressure from both AMD and DME,” Loewenstein said. – by Michela Cimberle

Disclosure: Loewenstein reports she is a consultant to Notal Vision, BeyeOnics, Allergan, Bayer, Roche and Novartis.

New longer-acting molecules and home monitoring will soon help relieve the increasing burden of age-related macular degeneration and diabetes-related ocular pathologies, both in patients and on public health delivery, according to one specialist.

“The number of patients who suffer from AMD is significantly on the increase due to the aging of the population. We are going to deal with more than 1 billion patients in the next decade, a big issue of public health,” Anat Loewenstein, MD, MHA, said in an interview with Ocular Surgery News.

The first priority is large-scale screening to detect people with the disease. Second is the detection of patients who convert from non-neovascular to neovascular disease. In the U.S. only, conversion to neovascular AMD occurs in as many as 2,000 cases per year, and often patients present to be examined too late, Loewenstein said. Once choroidal neovascularization has been detected, the next issue from a public health perspective is to monitor and manage the cases.

Anat Loewenstein, MD, MHA
Anat Loewenstein

“Prompt detection of disease recurrence is critical to the overall success of treatment,” she said.

Diabetes is growing to epidemic proportions in the Western world, mainly due to increased obesity rates. Screening is again the first critical step to detect patients with diabetes and, among them, those who develop diabetic retinopathy.

“We know that, over the years, most of the patients with diabetes will develop DR, so we need to screen large populations of diabetic patients for DR and diabetic macular edema. Once we identify them, the next major goal in public health is again monitoring and treating. In order to replicate in real life the good visual acuity results achieved in trials, we need to see our patients very often, find out when they have fluid and treat them promptly,” Loewenstein said.

Home monitoring OCT systems

Home monitoring systems may be an effective way to monitor patients regularly, reducing the burden of multiple visits for individuals and health care systems alike.

“I am involved in home-based monitoring with the Notal Vision OCT system, still a prototype for now. We have performed a large study involving two centers in Israel and two centers in America that included 350 eyes and were able to show that 90% of the people, even though they are old, up to 99 years of age, are able to self-operate the OCT and produce gradable images. These images were compared to those of two commercial OCTs, the Heidelberg Spectralis and the Zeiss Cirrus, showing a sensitivity and specificity for fluid detection of more than 90% with beautiful images. This device was already granted approval by the FDA, and we are concluding more studies in this regard,” Loewenstein said.

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Longer-acting drugs

Longer-acting drugs are another way of reducing the burden on patients and health care systems.

In October, the FDA approved Beovu (brolucizumab-dbll, Novartis) for the treatment of wet AMD on a 3-month dosing interval after a 3-month loading phase.

“Brolucizumab is administered by intravitreal injection every 3 months and seems to consistently dry retinal fluid even better than aflibercept.” Loewenstein said.

Phase 3 study results for abicipar pegol (Allergan) have demonstrated 8- and 12-week dosing regimens to be comparable to monthly treatment with Lucentis (ranibizumab, Genentech) for treatment of neovascular AMD. Two-year results presented at the American Academy of Ophthalmology annual meeting showed visual acuity gains were maintained with the longer dosing intervals.

Early results of the phase 3 studies raised concern over the high rate of intraocular inflammation resulting from the treatment. However, “The MAPLE study performed in Canada used a modified formulation that seems to have reduced the rate of inflammation by half,” Loewenstein said.

A third drug, faricimab (Genentech/Roche), is a molecule with bispecific action on VEGF and angiopoietin-2.

“Phase 2 results for AMD and DME show potential for longer duration, up to 3 months or even 16 weeks, and it is as good as ranibizumab monthly,” Loewenstein said.

Other molecules are under investigation at less advanced stages, including an injection of anti-VEGF in a viral vector to be delivered under the retina for sustained release of the drug.

“Patients will be able to come less often and will need fewer injections, and we will be able to monitor them at home. This will significantly ease health system pressure from both AMD and DME,” Loewenstein said. – by Michela Cimberle

Disclosure: Loewenstein reports she is a consultant to Notal Vision, BeyeOnics, Allergan, Bayer, Roche and Novartis.