Review Of Ophthalmology - July 16, 2018

Review of Ophthalmology Online
FROM THE EDITORS OF REVIEW OF OPHTHALMOLOGY:

Volume 18, Number 29

Monday, July 16, 2018

JULY IS UV SAFETY MONTH

In this issue: (click heading to view article)

		Risk of POAG Following Vitreoretinal Surgery

		Resolution, Depth of Field and Physician Satisfaction During Digitally Assisted Vitreoretinal Surgery

		Intravitreal Aflibercept for Exudative AMD with Good VA

		Switching from Prostaglandin Analog Monotherapy to Prostaglandin/Timolol Fixed Combination Therapy or Adding Ripasudil

		Briefly

Risk of POAG Following Vitreoretinal Surgery

Scientists determined the risk of primary open-angle glaucoma following vitreoretinal surgery, as part of a retrospective, population-based cohort study.

All residents of Olmsted County, Minn., undergoing scleral buckle and/or vitrectomy between 2004 and 2015 were included in the operative cohort. Fellow non-operative eyes were included in the comparison cohort. The study cohort consisted of 344 eyes and the comparison cohort consisted of 277 eyes. The main outcome measure was the development of POAG. Secondary glaucomas were excluded. Scientists compared the probability of glaucoma in operative eyes and nonoperative fellow eyes. The observed rate of POAG in operative eyes was also compared to the rate of POAG in the population.

The mean patient age was 64.7 years, and the median follow-up period was 4.9 years. A total of 58 eyes were in the scleral-buckle cohort, 57 eyes were in the scleral-buckle-with-vitrectomy cohort and 229 eyes were in the vitrectomy-only cohort.
• The 10-year cumulative probability of developing glaucoma was significantly greater in the operative group (CI, 3.8 to 14 percent) compared with the nonoperative group (1 percent, CI 0 to 2.4 percent; p=0.02).
• No eyes in the scleral buckle group developed glaucoma.
• The 10-year probability of POAG was 17.5 percent (CI 0 to 34.9 percent) in scleral buckle-with-vitrectomy and 10 percent (CI, 3 to 17 percent) in vitrectomy-alone cohorts.
• Rates of POAG in operative eyes undergoing scleral buckle with vitrectomy and vitrectomy alone were significantly greater than those of POAG for the general population (1 percent, p<0.001).

Scientists determined that the risk of POAG was increased after vitrectomy in this population.

SOURCE: Mansukhani SA, Barkmeier AJ, Bakri SJ, M, et al. The risk of primary open angle glaucoma following vitreoretinal surgery—a population-based study. Am J Ophthalmol 2018; June 22. [Epub ahead of print].

Resolution, Depth of Field and Physician Satisfaction During Digitally Assisted Vitreoretinal Surgery

Investigators evaluated depth of field, lateral resolution and image quality of a heads-up 3D visualization system for vitreoretinal surgery using physician survey and optical measurement outcomes. One of the investigators is employed by TrueVision Systems, which makes heads-up 3D viewing systems.

They compared depth of field and lateral resolution between the standard ocular viewing system and the digital 3D system at ×5, ×13 and ×18 magnification by six retinal surgeons. They also used optical techniques and a survey of surgeon impressions, performed after six weeks of surgical use.

• Physician questionnaire survey scores for depth of field at high magnification were better for the digital 3D system and equivalent for all other categories.
• Measured lateral resolution was, for digital 3D and oculars, respectively: 36.7 mm and 16.6 mm at ×5 magnification (p<0.001); 14.3 mm and 6.4 mm at ×13 magnification (p<0.001); and 9.8 mm and 4.2 mm (p<0.001) at ×18 magnification.
• Measured depth of field was 6.78 mm and 4 mm at ×5 magnification (p=0.027), 0.86 mm and 0.72 mm at ×13 (p=0.311), and 0.40 mm and 0.28 mm at ×18 magnification (p=0.235) for digital 3D and oculars, respectively.

Investigators concluded that lateral resolution of the digital 3D system was half that of the ocular viewing system, and depth of field showed some improvement with the digital system.

Source: Freeman WR, Chen KC, Ho J, et al. Resolution, depth of field and physician satisfaction during digitally assisted vitreoretinal surgery. Retina 2018; June 27. [Epub ahead of print].

Intravitreal Aflibercept for Exudative AMD with Good VA

Researchers reported the two-year outcomes of intravitreal aflibercept for exudative age-related macular degeneration with good visual acuity, and examined the baseline factors associated with good visual outcome.

The multicenter, prospective study evaluated 39 eyes (39 individuals with AMD) enrolled from August 2013 to August 2014, at 12 and 24 months. Only individuals with initial best-corrected VA (BCVA) >0.3 logMAR (20/40 Snellen) were eligible. Three consecutive monthly IVA injections were followed by two monthly injections for 12 months. Thereafter, individuals received injections on a treat-and-extend regimen for up to 24 months. Outcome measures included BCVA and central macular thickness at 12 and 24 months. Researchers evaluated post hoc analysis, BCVA and CMT by AMD types (typical AMD [tAMD], type 1 and type 2 polypoidal choroidal vasculopathy). They evaluated baseline characteristics and BCVA associations with linear regression analysis and Student’s t-test.

The mean age was 69 years, and 26 of 39 eyes were male. tAMD occurred in 18 eyes, type 1 occurred in 12 eyes and type 2 PCV occurred in nine eyes. Baseline mean BCVA was 0.097 logMAR (20/25 Snellen) and showed significant improvement to 0.058 (20/22 Snellen, p=0.03) at 12 months and 0.066 (20/23) at 24 months. CMT improved significantly from 320 ±99 µm to 250 ±93 µm (p=0.002) at 12 months and 240 ±93 µm (p=0.0005) at 24 months. BCVA and CMT weren’t significantly different among the three groups. Only subretinal hemorrhage was significantly associated with improved BCVA. BCVA change from baseline was -0.12 with SRH and -0.011 without SRH (p=0.017) at 12 months.

Researchers wrote that IVA showed good efficacy for exudative AMD with good VA at 24 months and that tAMD and type 1 and 2 PCV showed similar prognoses. They concluded that baseline SRH predicted favorable long-term vision in AMD with good VA.

SOURCE: Sakamoto S, Takahashi H, Inoue Y, et al. Intravitreal aflibercept for exudative age-related macular degeneration with good visual acuity: 2-year results of a prospective study. Clin Ophthalmol 2018;12:1137-47.

Switching from Prostaglandin Analog Monotherapy to Prostaglandin/Timolol Fixed Combination Therapy or Adding Ripasudil

Researchers compared the effectiveness and safety of switching from topical prostaglandin analog monotherapy to topical PG/timolol fixed combination therapy or adding topical ripasudil (Kowa’s Glanatec, a rho-kinase inhibitor available outside the United States) therapy, as part of an open-label, prospective, randomized, parallel group, comparative study.

Fifty-one individuals (51 eyes) with primary open-angle glaucoma who experienced insufficient intraocular pressure control while taking a PG analog were enrolled. The participants were divided into the following treatment groups: PG/timolol fixed combination (switched group) or ripasudil therapy addition (added group). Researchers measured blood pressure, IOP and pulse rate at baseline, and after one and three months of study treatment, and they examined adverse reactions and decreased effectiveness.

The mean IOP after three months of therapy was 14.3 ±2.2 mmHg in the switched group and 14.7 ±3 mmHg in the added group, both of which were significantly lower than those at baseline (switched, 16.3 ±3 mmHg; added, 16.6 ±2.8 mmHg; both p<0.001). At three months, the IOP was reduced by 2 ±1.7 mmHg (11.7 ±9.6 percent) in the switched group and by 1.8 ±2.1 mmHg (10.7 ±12.5 percent) in the added group. In the added group, the diastolic blood pressure after one month of therapy was significantly lower than that at baseline (p<0.05). In the switched group, 10 (40 percent) and two (8 percent) participants experienced adverse reactions at one and three months, respectively. In the added group, six (23.1 percent) and four (15.4 percent) participants experienced adverse reactions at one and three months, respectively. Treatment was discontinued in four participants (16 percent) in the switched group and in one participant (3.8 percent) in the added group.

Researchers reported that treatment changes involving either switching from a PG analog to PG/timolol fixed combination eye drops or adding ripasudil to PG analog therapy were equally safe and effective in reducing IOP.

SOURCE: Inoue K, Ishida K, Tomita G, et al. Effectiveness and safety of switching from prostaglandin analog monotherapy to prostaglandin/timolol fixed combination therapy or adding ripasudil. Jpn J Ophthalmol 2018; May 24. [Epub ahead of print].

FDA Accepts NDA Filing for B+L’s Loteprednol Etabonate
Bausch + Lomb announced that the FDA accepted the New Drug Application for its sub-micron loteprednol etabonate ophthalmic gel, 0.38%, with a Prescription Drug User Fee Act action date of Feb. 25, 2019. If approved, the product would be the lowest concentrated loteprednol ophthalmic corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. The company says this investigative product uses a novel submicron particle to help increase ocular penetration and residence time in anterior segment tissues. Read more.

Aura Biosciences Announces Findings From AU-011 Study for Choroidal Melanoma
Aura Biosciences announced new interim safety and efficacy data from an open-label Phase Ib/II study of its lead program, light-activated AU-011 for the treatment of primary choroidal melanoma, showing evidence of reduction in tumor height at three months. AU-011 is an investigational, first-in-class, targeted therapy to which the FDA has already granted Fast Track and orphan drug designation. AU-011 is being evaluated in an open-label, multicenter trial designed to evaluate the safety and efficacy of single and multiple ascending doses in 30 adult subjects with clinically diagnosed small to medium primary choroidal melanoma. The company says that interim data has also showed that AU-011 was generally well-tolerated with no related serious adverse events and no dose-limiting toxicities. Read more.

BioTime Awarded NIH Grant
BioTime received a $743,345 grant from the Small Business Innovation Research program of the National Institutes of Health. This award constitutes the second-year funding of a $1.6 million SBIR grant to advance BioTime’s retinal restoration program addressing advanced retinal diseases and injuries. BioTime says that data from the retinal restoration program have shown success in growing complete human three-dimensional retinal tissue derived from the company’s human pluripotent cells and in functional integration for advanced retinal degeneration in proof-of-concept animal models. The technology is being developed to potentially treat or prevent a variety of diseases and injuries leading to blindness. Read more.

Lin BioScience Receives EMA Orphan Drug Status for LBS-008
Lin BioScience, a drug development company targeting untreatable conditions in oncology, ophthalmology and metabolic diseases, announced that the European Medicines Agency granted orphan drug designation to LBS-008, a first-in-class oral therapy for the treatment of Stargardt’s Disease. Read more.

MPOD Measurement Earns AMA CPT III Code for Use in Research
EyePromise announced that its macular pigment optical density measurement by heterochromatic flicker photometry earned a category III CPT code from the American Medical Association. The code, which doesn’t receive paid reimbursement, is used for data collection and tracking for products or services involved in planned or ongoing research to help researchers substantiate widespread usage and efficacy, the company says. Read more.

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