DATA: WET AMD PATIENTS SKIPPING TREATMENTS
BY JULIE GREENBAUM, ASSOCIATE EDITOR
New data presented at AAO 2022 in Chicago revealed that one in nine people with wet AMD are foregoing sight-saving eye injections. Even with anti-VEGF eye injections available — which for a vast majority (nine out of 10) stabilizes vision (tinyurl.com/4mt8nvx5 ) — patients are still not returning for continued treatment.
Rahul N. Khurana, MD, lead researcher, from the University of California in San Francisco, and colleagues evaluated data from the IRIS Registry to gain insight into how many patients across the nation are skipping follow-up exams. The data showed that of 162,825 patients newly diagnosed with wet AMD between 2013 and 2015, 11% were lost to follow up during a 4-year study period. But the number of patients may be higher now, the researchers noted, since the COVID-19 pandemic prevented some patients from coming in for regular exams.
According to the data, those most likely to be lost to follow-up were of African American or Hispanic descent, older than age 75, male and covered by Medicaid.
Discontinuation in anti-VEGF treatment is nothing new to Rishi Singh, MD, of the Cleveland Clinic, who says he’s surprised the number of patients missing injections is not higher. “It results from a variety of factors — treatment success, where the patient responds and does not require additional medications, patient failure, when the patient’s disease is not responsive to the treatment and they lose significant vision and non-adherence to appointments. The biggest issue that retina specialists face is durability.”
EDUCATING PATIENTS
The study reinforces the need to educate patients on the importance of treatment. In an effort to help patients keep their appointments, Dr. Singh says that his practice uses several methods of communication. “First, we talk about the need for adherence when we begin treatments. We talk about the value of each incremental injection and success stories when patients receive regular treatment. When patients do not come in our office, staff is proactive about calling and scheduling them and sending them reminders.
FINDING AN ALTERNATIVE
Daniel Kiernan, MD, FACS, The Eye Associates in Sarasota, Fla., says wet AMD patients could benefit from treatments that require fewer visits, such as anti-VEGF treatments that have longer intervals.
“Longer duration, in-office injection options such as aflibercept or faricimab may benefit patients compared to earlier generation monthly treatments by allowing extension to every 2 to 4 months,” he says. “Newer biosimilars may also play a role in our treatment paradigm as insurance step edit requirements may dictate the order of our decisions. It is critical to stay abreast of these data.” OM
GLAUCOMA PATIENTS AT RISK OF ALZHEIMER’S DISEASE
A study presented at AAO 2022 showed that people who have normal-tension glaucoma (or low-tension glaucoma) are at high risk for developing Alzheimer’s disease and should be screened for this disease.
Researchers of the nationwide study from Taiwan analyzed data from the Taiwan National Health Insurance Research Database that was collected over a 12-year period. They compared the incidence of Alzheimer’s in 15,317 people with normal-tension glaucoma and 61,268 age- and gender-matched people without glaucoma.
According to the study, after adjusting for diabetes, hypertension, hyperlipidemia, coronary artery disease and stroke, the researchers found that people with normal-tension glaucoma were 52% more likely to develop Alzheimer’s compared with those without glaucoma. Those who were older, female or had a history of stroke had the highest incidence. The researchers also found that use of glaucoma eyedrops did not protect against Alzheimer’s disease or increase the incidence.
The study further shows more evidence that glaucoma and Alzheimer’s disease share a common cause — neurodegeneration — since both diseases occur when nerve cells deteriorate and die.
It is hoped that further investigation into the similarities and differences between these illnesses will help with the introduction of new treatments for both conditions. OM
IN THE NEWS:
Novaliq announced the FDA accepted the new drug application for CyclASol (cyclosporine ophthalmic solution), an anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease. The Prescription Drug User Fee Act target action date set by the FDA for announcing its decision on Novaliq’s NDA after reviewing the application is June 8, 2023.
NovaSight announced the FDA has cleared CureSight, a digital therapy device for amblyopia. The eye-tracking-based system is designed for improving visual acuity and stereo acuity by training the visual system to use both eyes simultaneously, while the user watches any streamed video content of choice through red-blue treatment glasses.
Genentech is voluntarily recalling the Susvimo (ranibizumab injection) ocular implant and insertion tool for the treatment of people with wet AMD in the United States. The recall is based on recent testing of Genentech’s commercial supply in which Susvimo implants were exposed to repeated puncturing with a needle. Genentech also reported positive topline results from two global Phase 3 studies, BALATON and COMINO, evaluating the first bispecific antibody for the eye, Vabysmo (faricimab-svoa), in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). Both studies met their primary endpoints.
Salvat Laboratories submitted a new drug application to the FDA for the approval of Clobetasol Nanoemulsion, the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in post-ocular surgery patients. This submission comes after two successful Phase 3 clinical trials conducted between 2020 and 2021.
Lenstec Inc. rebranded its new multifocal IOL to the ClearView 3. The rebrand occurred to better describe the vision patients can expect with the new IOL, the company says. ClearView 3 is a next-generation asymmetric multifocal refractive IOL that is used in adult patients who have cataracts, need eye surgery and only have 1 D or less of abnormal curve to the cornea.
Olleyes Inc. announced a partnership with Tobii to incorporate advanced eye-tracking features within the VisuALL ETS package. By utilizing Tobii eye tracking, the VisuALL ETS stimulus remains consistent with the same region of the retina regardless of user error, vastly increasing the precision of the data and improving doctors’ ability to confidently diagnose their patients.
DORC International announced the acquisition of Peregrine Surgical and the acquisition of the full ownership of WEFIS GmbH following an initial equity investment announced earlier in 2022. Both acquisitions significantly extend the production and innovation capabilities of the business while expanding the geographic reach and speed-to-market of DORC’s strategy.
Cellusion Inc. and Minaris Regenerative Medicine announced Letter of Intent (LOI) of the manufacturing of CLS001 for a corneal endothelial cell regenerative therapy in the United States. Cellusion and Minaris will develop the manufacturing process of Cellusion’s leading program, CLS001, a novel regenerative medicine product for bullous keratopathy treatment.
Tarsus Pharmaceuticals reported the results from the Saturn-2 pivotal Phase 3 trial of TP-03 (lotilaner ophthalmic solution, 0.25%) in Demodex blepharitis patients. Results from the trial revealed statistically significant (P < .01) complete collarette cure (CC) (0-2 collarettes) and clinically meaningful CC (≤10 collarettes), along with reduction of lid erythema and eradication of mites.
TearClear announced the company’s lead product, TC-002 (latanoprost ophthalmic solution 0.005%), met the primary and all secondary endpoints in the CLEAR Phase 3 pivotal trial that evaluated the efficacy and safety of TC-002 in patients with elevated IOP. The primary efficacy endpoint was the difference in mean change from baseline in IOP at weeks 2, 6 and 12 at 8 a.m., 10 a.m. and 4 p.m.
Eyenovia Inc. reported positive results from its VISION-2 Phase 3 study of MicroLine as a potential topical treatment for presbyopia. VISION-2 met its primary endpoint with a statistically significant proportion of subjects treated with MicroLine showing a 15-letter or more improvement in distance-corrected near visual acuity with less than a 5-letter loss in distance acuity vs placebo in low light conditions at 2 hours post-treatment.
LENZ Therapeutics reported positive topline results from its Phase 2 INSIGHT clinical trial of two investigational formulations of aceclidine to treat presbyopia. Both LNZ100 (aceclidine) and LNZ101 (aceclidine + brimonidine) achieved the primary endpoint of three-line or greater improvement in near visual acuity, without losing one line or more in distance visual acuity.
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