Review of Ophthalmology Online



Vol. 22, #31  •   Monday, July 26, 2021


In this Issue:


A message from Review’s Chief Medical Editor, Mark H. Blecher, MD: Request Denied

This is a discussion way too complex for a short blurb, but worth a go because it’s so timely. I’ll likely revisit this discussion in more detail in my ‘Forum’ in Review of Ophthalmology soon. We are all aware of the sudden change in policy at Aetna requiring 100-percent preauthorization for cataract surgery. We’ve seen this before with other insurers, but mostly covering Medicaid plans. Now, however, it’s being instituted by the number-three commercial insurer in the United States, which affects many more lives and livelihoods. What made this even more challenging was the short timeline provided and the inept rollout of the policy, causing thousands of canceled and delayed surgeries.

There are lessons and warnings here. Despite the coordinated efforts of all our organizations, Aetna persisted without even an acknowledgment of the tremendous difficulties they caused. They can do that because health care in the United States isn’t a free market. It isn’t a free market not because of the big, bad government, but because of the dominance of a corporate oligarchy. If you’re not familiar with this term you should be. It best describes the current economic model in the United States. You see it in health care, where the top three insurers are so dominant that there’s essentially no negotiation and they’re free to do as they wish. And a publicly-traded company such as Aetna (owned by CVS) answers to its shareholders, not to us, and not to their subscribers.

This is only the beginning….

Mark H. Blecher, MD
Chief Medical Editor
Review of Ophthalmology





Cataract Surgery & IOP in the Medication Group of the OHTS

Researchers determined the change in intraocular pressure with ocular hypotensive medication use after cataract extraction in the medication group of the Ocular Hypertension Treatment Study, as part of a secondary analysis of randomized clinical trial data.

They included 92 participants (n=149 eyes) of the OHTS Medication Group who underwent cataract surgery in at least one eye during the study, and 531 participants (n=1,004 eyes) of the medication group who didn’t undergo cataract surgery. They defined the “split date” as the first study visit that cataract surgery was reported for the cataract surgery group, and the fifteenth visit in the control group, to equalize the median number of visits. They then compared the two groups at visits relative to this split date.

Main outcome measures included the difference in preoperative and postoperative IOP, and number of classes of ocular hypotensive medications between the cataract and control group over a 72-month period.

Here were some of the findings:
• Cataract surgery significantly decreased the number of ocular hypotensive medications at all postoperative visits (mean -0.4 medications, p<=0.005) through the 48-month postoperative visit when compared to the control group.
• At the split date, approximately 23 percent of eyes were medication-free, and 41 percent had a reduced medication burden.
• Cataract surgery resulted in a decrease in IOP (p<0.001), but the difference in IOP between the groups decreased over time and became non-significant after 12 months.

Researchers concluded that cataract surgery in ocular hypertension patients produced sustained reductions in the average number of ocular hypotensive medications and transient reductions in intraocular pressure.

SOURCE: Mansberger SL, Gardiner SK, Gordon M, PhD, et al. Cataract surgery lowers intraocular pressure and medication use in the Medication Group of the Ocular Hypertension Treatment Study. Am J Ophthalmol 2021; Jul 16. [Epub ahead of print].




nAMD Managed by a Treat-Extend-Stop Protocol

Investigators assessed vision, injection quantity, initial lesion size and final anatomic status in patients with nAMD completing the treat-extend-stop protocol.

Patients with nAMD received ≥3 monthly anti-VEGF injections followed by one- to two-week injection interval extensions, with intra-/subretinal fluid resolution on SD-OCT to 12 weeks. With quiescent disease and two quarterly injections, patients were monitored alone beginning at four weeks extending by one- to two-week intervals until quarterly monitoring.

Eighty-eight of 143 eyes with nAMD completed the TES protocol without disease recurrence. Here are some of the findings:
• Sixteen (18.2 percent) developed subfoveal geographic atrophy, 25 (28.4 percent) developed fibrovascular scarring (FV) and 47 (53.4 percent) developed regressed choroidal neovascularization (rCNV) with 16.9 ±13.3 average injections between the three groups, which wasn’t statistically significant.
• Average treatment time was 30.3 ±26.1 months, and subsequent follow-up was 23.2 ±19.8 months.
• Average lesion size for FV was 18.77 ±10.8 mm2 vs. GA at 12 ±9.99 mm2 vs. regressed CNV at 7.12 ± 6.5 mm2 (p<0.05).
• Pre-, post- and final vision for GA was 39.6 letters (20/160) vs. 32.7 letters (20/200 + 2, p=0.4725) vs. 25 letters (20/320, p=0.0865).
• FV was 22.4 letters (20/400 + 2) vs. 11.6 letters (20/640, p=0.0351) vs. 11 letters (20/640 + 1; p=0.0226); and rCNV was 56.4 letters (20/80 + 1) vs. 69.5 letters (20/40, p<0.001) vs. 67.3 letters (20/40-2, p=0.0016).
• In the rCNV group, 17/46 eyes gained ≥3 lines and 30/46 eyes achieved ≥ 20/40 vision.
• Non-central GA expanded 0.226 ±0.126 mm vs. 0.225 ±0.098 mm during and after treatment completion over 24 months (p=0.99).

Investigators wrote that central GA or FV was associated with worse visual outcomes (as opposed to rCNV) after cessation of therapy. They added that anti-VEGF therapy may not affect the rate of GA expansion and that final anatomic character and location are key determinants of final vision.

SOURCE: Adrean SD, Chaili S, Pirouz A, et al. Results of patients with neovascular age-related macular degeneration managed by a treat-extend-stop protocol without recurrence. Graefes Arch Clin Exp Ophthalmol 2021; Jul 12[ Epub ahead of print].


Complimentary CME Education Videos


Smartphone Use & Refractive Errors in Teenagers: The Myopia App Study

Scientists looked at the association between smartphone use and axial length and refractive error in teenagers using a myopia app, as part of a cross-sectional population-based study.

A total of 525 teenagers ages 12 to 16 from six secondary schools and from the birth cohort study Generation R participated.

A smartphone application (a myopia app) was designed to objectively measure smartphone use and face-to-screen distance, and to pose questions about outdoor exposure at regular intervals. Participants underwent cycloplegic refractive error and ocular biometry measurements. Mean daily smartphone use was calculated in hours per day. Linear mixed models were conducted with smartphone use, continuous use and face-to-screen distance as determinants. Spherical equivalent refraction (SER), and the ratio of axial length and corneal radius (AL/CR) were outcome measures stratified by median outdoor exposure. Main outcome measures were SER in diopters and AL/CR ratio.

The teenagers were on average 13.7 (0.85) years old; 54 percent were girls. Myopia prevalence was 18.9 percent. Here are some of the findings:
• During school days, total smartphone use was on average 3.71 (1.70) hours/day, and was only borderline significantly associated with AL/CR (β=0.008, CI, -0.001 to 0.017) and not with SER.
• Continuous use was on average 6.42 (4.36) episodes of 20 minutes use without breaks/day, and was significantly associated with SER (β=-0.07; CI, -0.13 to -0.01) and AL/CR (β=0.004; CI, 0.001 to 0.008).
• When stratifying for outdoor exposure, continuous use remained only significant for teenagers with low exposure (β=-0.10; CI, -0.20 to -0.01 for SER; and β=0.007, CI, 0.001 to 0.013 for AL/CR).
• Smartphone use during weekends wasn’t significantly associated with SER and AL/CR, nor was face-to-screen distance.

Scientists found that Dutch teenagers spent almost four hours per day on their smartphones and that episodes of 20-minute continuous use was associated with more myopic refractive errors, particularly in those with low outdoor exposure. This study suggested that frequent breaks should become a recommendation for smartphone use in teenagers. Scientists suggested that future large longitudinal studies would allow more detailed information on safe screen use in youth.

SOURCE: Enthoven CA, Polling JR, Verzijden T, et al. Ophthalmology 2021; Jul 7:S0161-6420(21)00518-2.


Intravitreal Application of Epidermal Growth Factor in Non-Exudative AMD

Researchers assessed the safety of intravitreally applied epidermal growth factor (EGF).

The clinical interventional, prospective, single-center case series study included patients with age-related macular degeneration-related geographic atrophy, in whom the eye with the worse best-corrected visual acuity underwent a single, or repeated, intravitreal injection of EGF (0.75 µg in 50 µL). At baseline and afterwards, the eyes underwent ophthalmological exams.

The study included seven patients (mean age: 70.0 ±12.2 years (range: 54 to 86 years), with five patients receiving a single injection and two patients receiving two intravitreal injections in an interval of four weeks. Here are some of the findings:
• Mean duration of follow-up was 97 ±97 days (median: 35 days; range: 7 to 240 days).
• Mean BCVA was lower at baseline than at study end (1.41 ±0.44 logMAR vs. 0.97 ±0.12 logMAR; p=0.03).
• Mean size of the GA lesions didn’t differ significantly between baseline and study end (29 212 ±22 887 pixels vs. 29 300 ±22 905 pixels; p=0.59) nor did that of the mean perimetric mean defect (-10.3 ±5.9 dB vs. 12.0 ±8.8 dB; p=0.35) or that of the electroretinographical b-wave amplitude (44.53 ±31.7 µV vs. 64.5 ±25.5 µV; p=0.12).
• After a second injection four weeks after the first injection, one of two patients developed cystoid macular edema in association with an induced incomplete posterior vitreous detachment. It persisted for three weeks. Visual acuity in this eye improved from 1.0 logMAR at baseline to 0.80 logMAR at study end.

Researchers reported that, with the exception of one eye with temporary, self-resolving cystoid macular edema, single and repeated intravitreal applications of EGF (0.75 µg) in patients with GA didn’t lead to intraocular inflammations or any observed intraocular side effect.

SOURCE: Bikbov MM, Khalimov TA, Panda-Jonas S, et al. Intravitreal application of epidermal growth factor in non-exudative age-related macular degeneration. Br J Ophthalmol 2021; Jul 14. [Epub ahead of print].




Industry News

B+L to Present 14 Scientific Posters at ASCRS Annual Meeting

Bausch + Lomb announced the presentation of 14 scientific posters involving the company’s ophthalmic surgical technologies at the American Society of Cataract and Refractive Surgery annual meeting, July 23-27 in Las Vegas. The presentations include information on the company’s intraocular lens platforms and the cloud-based eyeTELLIGENCE software. View the schedule of presentations.


J&J Vision to Present Data on Latest Cataract Innovations at ASCRS Annual Meeting

Johnson & Johnson Vision announced that 21 company-sponsored studies supporting cataract surgery outcomes will be presented at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting. A complete listing of abstracts related to Johnson & Johnson Vision can be found on the ASCRS website. Read more.



Allergan to Present Data from Eye-care Portfolio at ASCRS Annual Meeting

Allergan will present new data from its portfolio of eye care medicines at the American Society for Cataract and Refractive Surgery Annual Meeting. Presentations will include new data on AGN-190584 (pilocarpine 1.25%), an investigational presbyopia treatment, and updated analyses on Durysta (bimatoprost intracameral implant). View the schedule of presentations.



Alcon to Present 70 Abstracts at ASCRS Annual Meeting

Alcon announced it would have approximately 70 abstracts highlighting the benefits of the Alcon cataract and refractive suite at the American Society for Cataract and Refractive Surgery Annual Meeting. The presentations include data on PanOptix and Vivity IOLs, the ARGOS Biometer with Image Guidance and the NGENUITY 3D Visualization System Heads-Up Display. View the ASCRS website for a list of presentations.

Allegro Ophthalmics to Present Results of ALG-1007 Ex-U.S. Phase II Trial at ASCRS Annual Meeting

Allegro Ophthalmics announced the results of the company’s second ALG-1007 ex-U.S. clinical trial for the treatment of dry-eye disease will be presented during the ASCRS/ASOA meeting. On July 24, Eric D. Donnenfeld, MD, will present full study results of the company’s second ALG-1007 ex-U.S. clinical trial for DED. View the schedule of presentations.

More OpRegen Data in Patients with Dry AMD with GA Released

Lineage Cell Therapeutics reported updated interim results from its ongoing, 24-patient Phase I/IIa clinical study of its lead product candidate, OpRegen. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium cells, administered one time to the subretinal space, for the treatment of dry age-related macular degeneration with geographic atrophy. These updated results include a minimum of six months of follow-up in all 24 patients treated with OpRegen, including all 12 patients treated in cohort 4, which had better baseline vision and smaller areas of GA at baseline than earlier cohorts. Read more.

Nanoscope Announces First Patient Dosed in Phase IIb Trial

Nanoscope Therapeutics announced the first patient was dosed in its Phase IIb clinical trial of MCO-010, an ambient-light activatable optogenetic monotherapy to restore vision in patients with retinitis pigmentosa. Based on preliminary evidence from the company's Phase I/IIa study, MCO-010 has received FDA orphan drug designations for RP and Stargardt’s disease. Read more.

Harrow Health Granted Two Patents for Novel Surgical Dilation Formulation

Harrow Health announced the U.S. Patent and Trademark Office issued two Patents titled “Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof.” Read more.

NovaBay Partners with ImprimisRx to Promote Prescription Avenova

NovaBay Pharmaceuticals is partnering with ImprimisRx, a wholly owned subsidiary of Harrow Health, to promote prescription lid and lash cleanser Avenova. Read more.

Lensar Announces Presentations at ASCRS Annual Meeting

Lensar announced 12 abstracts highlighting Lensar’s technology were accepted for presentation at ASCRS. In addition, the company will host in-person demonstrations of its ALLY Adaptive Cataract Treatment System, which combines the femtosecond laser with phaco technology. Lensar expects to submit a 510(k) application for regulatory clearance of ALLY in the first quarter of 2022. View the list of presentations.

Nanodropper & Unite For Sight Announce Global Health Partnership

Nanodropper is joining forces with Unite For Sight to launch a global health initiative aimed at providing better access to vision-saving medications in Ghana. The initiative will allow the public to donate Nanodroppers to Unite For Sight partner clinics in Ghana at $9 per adaptor, a substantially lower price than retail value. The company says the Nanodropper reduces the waste from a typical eyedrop. Learn more.

Euclid Systems Appoints Dr. Thompson as Chief Medical Officer

Euclid Systems appointed Vance Thompson, MD, an internationally recognized authority in laser vision correction and advanced cataract surgery, to the position of chief medical officer. Read more.










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