Review of Ophthalmology Online



Vol. 22, #28  •   Monday, July 5, 2021


In this Issue:


Gonioscopy-assisted Transluminal Trabeculotomy in PACG

Researchers reported on outcomes of gonioscopy-assisted transluminal trabeculotomy in eyes with primary angle-closure glaucoma. This prospective, interventional, non-comparative case series included 103 eyes from 88 patients with PACG that underwent an ab interno trabeculotomy using either a 5-0 polypropylene suture or an illuminated microcatheter, with up to 24 months of follow-up.

The main outcome measures were intraocular pressure, number of anti-glaucoma medications, success rate (IOP reduction ≥20 percent from baseline or IOP between 6 and 21 mmHg, without further glaucoma surgery) and complication rate.

The mean preoperative IOP was 21.4 ±7.4 mmHg using 2.5 ±1.1 glaucoma medications. Mean IOP decreased postoperatively to 12.1 ±2.4 mmHg, and the number of medications decreased to 0.8 ±1.2 medications at 24 months (p<0.05). Success rate was 78 percent at 24 months of follow-up, and complication rate was 4.8 percent.

At 24 months of follow-up, researchers found that GATT effectively lowered IOP in PACG, with a low complication rate.

SOURCE: Sharkawi E, Artes PH, Lindegger DJ, et al. Gonioscopy-assisted transluminal trabeculotomy in primary angle-closure glaucoma. Graefes Arch Clin Exp Ophthalmol 2021; Jun 22. [Epub ahead of print].




Differentiating Exudative Macular Degeneration and PCV Using OCT B-scan

Although polypoidal choroidal vasculopathy is best diagnosed with indocyanine green angiography, ICGA is often unavailable or not ordered. Optical coherence tomography is widely available, and OCT B-scans can visualize polypoidal lesions diagnostic of PCV as inverted U-shaped elevations of the retinal pigment epithelium with heterogeneous reflectivity and sometimes ring-shaped lesions within the polypoidal lesion. This study aimed to differentiate findings between eyes diagnosed with PCV or typical exudative age-related macular degeneration using ICGA, and then compared findings noted on the OCT B-scan line scan in each group.

The retrospective chart review compared clinical features of PCV eyes and typical exudative AMD based on ICGA. Eyes with PCV were evaluated for inverted U-shaped polypoidal lesions, which are the main differentiating finding of PCV from typical exudative AMD. Data collected included: presence of subretinal fluid (SRF); macular edema or intraretinal edema (ME); subretinal hyperreflective material (SHRM); and retinal pigment epithelial detachment (RPED). These findings were evaluated at baseline and after six to nine months of antiangiogenic therapy. Additionally, analysis was performed for the presence of polypoidal lesions before and after treatment. A total of 112 eyes of 106 patients were included.

The researchers found the following:
• Sixty-nine eyes were diagnosed with PCV and 43 were diagnosed with typical exudative AMD.
• Compared to AMD eyes, PCV eyes had an increased prevalence of SRF at baseline and after six to nine months of treatment, but the prevalence of ME, SHRM and RPED were similar at baseline and at six to nine months after treatment.
• In PCV eyes, the presence of visible polypoidal lesions decreased from 56.5 to 24.6 percent after treatment.

Investigators wrote that a characteristic inverted U-shaped elevation was present in more than half of eyes with polypoidal choroidal vasculopathy on OCT B-scan at baseline, but it disappeared following antiangiogenic therapy in 56.4 percent of cases. They added that subretinal fluid was more prevalent in PCV eyes than non-PCV AMD eyes. Investigators suggested that, if PCV is suspected in an anti-vascular endothelial growth factor-resistant case of exudative AMD, it's important in the absence of ICGA availability to look at the baseline B-scan OCT prior to therapy for evidence of polypoidal lesions.

SOURCE: Kokame GT, Omizo JN, Kokame KA, et al. Differentiating exudative macular degeneration and polypoidal choroidal vasculopathy using optical coherence tomography B-scan. Ophthalmol Retina 2021 May 19. [Epub ahead of print].


Complimentary CME Education Videos


Corneal Neurotization for Neurotrophic Keratopathy

Scientists described the results of—and ongoing issues related to—corneal neurotization (CN) for the treatment of neurotrophic keratopathy (NK).

They described the advantages and disadvantages of two particular surgical approaches (direct and indirect CN), and assessed changes in corneal sensitivity in addition to clarity, visual acuity and in vivo confocal microscopy metrics. They also reported on ex vivo studies with histopathology of the neurotized cornea, as well as intraoperative and early and late postoperative complications.

They found that corneal sensitivity improved after both direct and indirect CN. Corneal reinnervation allowed the healing of NK in almost all operated eyes, yielding a corresponding improvement of corneal clarity and visual acuity. Scientists reported on the regeneration of corneal nerve fibers by means of in vivo confocal microscopy and ex vivo histopathology. They noted that few self-limiting complications were documented during the postoperative course. They added that ongoing issues relate to identifying the technique of choice, use of autograft or allograft, and the timing of CN when performed alone or with other surgeries.

Scientists wrote that CN represented a “game-changing” surgical procedure for neurotrophic keratopathy that has the potential to restore corneal sensitivity in all stages of the disease regardless of the mechanism of denervation. They added that additional long-term results are needed to confirm its efficacy over time.

SOURCE: Giannaccare G, Bolognesi F, Pellegrini M, et al. Corneal neurotization: A game-changing surgical procedure for neurotrophic keratopathy. Cornea 2021; Apr 14. [Epub ahead of print].


Comparing Treatment Outcomes Between Subthreshold Micropulse Laser and Aflibercept for DME

Researchers compared two-year treatment outcomes of subthreshold micropulse (577 nm) laser and aflibercept for diabetic macular edema, as part of a retrospective case-control study.

A total 164 eyes in 164 DME patients treated with either micropulse laser (86 eyes) or intravitreal aflibercept monotherapy (78 eyes) were recruited. Main outcome measures included at least five Early Treatment Diabetic Retinopathy Study letters' improvement from baseline at six, 12 and 24 months.

Here are some of the findings:
• Rescue aflibercept was initiated in 24 percent of eyes in the micropulse laser group.
• At the six-month visit, the aflibercept group achieved a higher percentage of eyes with at least five-letter visual acuity improvement than the micropulse laser group (56 vs. 38 percent; p=0.044); however, this wasn’t the case at 12-month visits (45 vs. 49 percent; p=0.584) and 24-month visits (49 vs. 57 percent; p=0.227).
• At six-month visits, the aflibercept group had a higher percentage of eyes with at least a 10-percent improvement of central macular thickness (73 vs. 49 percent; p=0.005), but this wasn’t the case at 12-month visits (73 vs. 70 percent; p=0.995) and 24-month visits (85 vs. 84 percent, p=0.872).

Researchers found that aflibercept achieved faster and higher rates of anatomical and functional improvement than micropulse laser in DME patients, though long-term efficacy of treatment didn’t result in significant differences between aflibercept monotherapy and micropulse laser. Researchers suggested that micropulse laser potentially could serve as primary treatment with deferred aflibercept rescue without reducing the chance of visual improvement in DME eyes.

SOURCE: Lai FHP, Chan RPS, Lai ACH, et al. Comparison of two-year treatment outcomes between subthreshold micropulse (577 nm) laser and aflibercept for diabetic macular edema. Jpn J Ophthalmol 2021; Jun 14. [Epub ahead of print].




Industry News

Santen Receives FDA Approval for Verkazia for Vernal Keratoconjunctivitis

Santen announced the FDA approved Verkazia (cyclosporine ophthalmic emulsion) 0.1% eye drops for the treatment of vernal keratoconjunctivitis in children and adults. Verkazia is a prescription-only, oil-in-water cationic emulsion that the company says provides improved ocular bioavailability of cyclosporine, which has been shown to be effective in the management of VKC. It works by inhibiting T-cell activation and reducing the level of immune cells and mediators that cause the allergic inflammation of the ocular surface seen in those affected by VKC. Read more.

Regenerative Patch Technologies Announces Results from Phase I/IIa Trial

Regenerative Patch Technologies announced results from its Phase I/IIa clinical trial of its CPCB-RPE1 implant for dry age-related macular degeneration. The CPCB-RPE1 implant, a bio-engineered scaffold supporting a layer of stem cell-derived retinal pigmented epithelial cells, was delivered to the worst eye of 15 subjects with geographic atrophy. All treated eyes had a best-corrected visual acuity of 20/200 or worse. At an average of 34 months post-implantation, 27 percent (4/15) showed a greater than five-letter improvement in BCVA, and 33 percent (5/15) remained stable with a BCVA within five letters of baseline. Read more.

Glaukos Completes Patient Enrollment in Phase III iDose TR Trials

Glaukos completed patient enrollment and randomization for its FDA New Drug Application Phase III clinical trials for the iDose TR sustained-release travoprost implant. The clinical program will compare the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release rates to topical timolol ophthalmic solution, 0.5% b.i.d., in reducing elevated intraocular pressure in subjects with open-angle glaucoma or ocular hypertension. Read more.

Atsena Receives FDA Orphan Drug Designation for Gene Therapy

Atsena Therapeutics announced the FDA granted orphan drug designation for its investigational gene therapy product for the treatment of GUCY2D-associated Leber’s congenital amaurosis. The safety and efficacy of the therapy are being evaluated in a Phase I/II clinical trial, which is currently enrolling patients. Read more.


Amydis Receives $3 Million Grant for Novel Amyloid Beta Retinal Tracer

Amydis announced an award of a $3 million grant from the National Institute of Aging at the National Institutes of Health. The two-year Commercialization Readiness Pilot Program award will provide additional funding toward a clinical trial to test Amydis’ small-molecule retinal tracer targeting the biomarker amyloid beta for the diagnosis of amyloid angiopathy. Read more.

Recycling of the Eye’s Light Sensors is Faulty in Progressive Blindness

University of Maryland School of Medicine researchers have found the process that removes the eye’s old photoreceptors is disrupted in age-related macular degeneration, according to the findings published June 23 in Nature Communications. The team compared healthy mouse eyes to those from a mouse engineered without the CIB2 protein, which is needed for vision, and found the CIB2 mutant mice weren’t getting rid of their old photoreceptors like healthy mouse eyes did. They identified several components in a photoreceptor recycling process, including mTORC1 proteins, that clean up cellular debris. The proteins were overactive in CIB2 mutant mice and in human eye tissue samples from individuals with AMD. The researchers say the findings suggest that drugs against mTORC1 might be effective treatments for the most common type of AMD. Read more.

Aurion Names Dr. Holland Chief Medical Advisor

Edward Holland, MD, was named chief medical advisor of Aurion Biotech. Dr. Holland will help advance the company’s lead candidate, cell therapy for the treatment of corneal endothelial disease, and help expand the company’s platform of therapies. Read more.

Second Sight Announces Closing of Public Offering

Second Sight Medical Products announced the closing of its previously announced underwritten public offering of 11,500,000 shares of its common stock at a public offering price of $5 per share. The company intends to use the net proceeds for development of the Orion device and general corporate purposes. Read more.

Dexycu to Get New Category III CPT Code

EyePoint Pharmaceuticals announced that the American Medical Association’s Current Procedural Terminology Editorial Panel accepted the addition of a new Category III CPT code, 0X78T, for the administration of a drug into the posterior chamber of the anterior segment of the eye, effective January 1, 2022, which EyePoint says provides an opportunity for a reimbursement pathway for the administration of Dexycu, the company’s single dose, sustained-release, intracameral steroid for the treatment of postoperative inflammation. Learn more.

Topical Presbyopia Treatment Set to Move to Phase III

Ocuphire Pharma announced that its VEGA-1 Phase II clinical trial of Nyxol in combination with low-dose pilocarpine (LDP) in presbyopes met its primary and many secondary endpoints. Specifically, 61 percent of subjects treated with Nyxol + LDP improved 15 letters or greater (≥ 3 lines) in photopic binocular near vision at one hour compared with 28 percent of subjects on placebo with statistical significance (p=0.003 with placebo-adjusted difference of 33 percent). Ocuphire now plans to move the drug into Phase III. Read more.


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