- FDA approves spheric, monofocal IOL
- Phase 2/3 study of gene therapy for retinitis pigmentosa does not meet primary endpoint
- Study: Compounded cyclosporine drop significantly improves OSDI scores
- Subretinal injector receives FDA pre-market approval
- Three companies form strategic alliance to develop cell therapies
- ASCRS events
May 21, 2021 • Volume 27, Number 20
FDA approves spheric, monofocal IOL
Rayner announced FDA approval of its RayOne Spheric IOL, a preloaded monofocal IOL. According to the company, the RayOne platform is hydrophilic and acrylic. The company’s press release described this platform as having a 0.08 mm mean decentration at 3–6 months, low PCO (1.7% at 24 months), an Abbe value of 56, and a refractive index of 1.46.
Phase 2/3 study of gene therapy for retinitis pigmentosa does not meet primary endpoint
Biogen announced that its Phase 2/3 study of a gene therapy (cotoretigene toliparvovec [BIIB112]) did not meet its primary endpoint as a possible therapy for X-linked retinitis pigmentosa, for which there are currently no approved treatments. The primary endpoint of the XIRIUS study was a statistically significant improvement in the proportion of treated study eyes with a 7 dB or greater improvement from baseline at 5 or more of the 16 central loci on the 10-2 grid assessed by the Macular Integrity Assessment microperimetry, the company’s press release explained. While the primary endpoint was not met, the company noted that there were positive trends toward several clinically relevant prespecified secondary endpoints, such as visual acuity in low light situations.
Study: Compounded cyclosporine drop significantly improves OSDI scores
ImprimisRx announced the publication of a study that found its compounded, preservative-free emulsion of cyclosporine 0.1% Klarity-C Drops significantly improved OSDI scores. The study published in Clinical Ophthalmology was retrospective and multicentered, including 100 eyes of 50 patients who had a baseline OSDI score of more than 12 and corneal staining grade over 1. At 3 months, there was a significant improvement in OSDI from baseline (from a mean of 38.19 to 24.18) and in corneal staining grade from baseline (mean 3.62 to 2.20). Severe dry eye categorization was reduced from 31 patients to 10, and 17 patients achieved OSDI scores within the normal range, the company’s press release reported. At baseline, 21 patients had corneal staining grades of 2 or 3, which dropped to 8 after treatment, and 50 of the 100 eyes had no corneal staining.
Subretinal injector receives FDA pre-market approval
MedOne received 510(k) pre-market approval from the FDA for its MicroDose injector, which connects with viscous fluid injection tubing to a console in aspiration mode, allowing surgeons to inject fluid at a low pressure. According to the company’s website, the system gives the surgeon more control while performing subretinal injections and reduces fluid loss.
Three companies form strategic alliance to develop cell therapies
BlueRock Therapeutics, a biopharmaceutical company and Bayer wholly owned subsidiary, FUJIFILM Cellular Dynamics, a developer and manufacturer of human induced pluripotent stem cell technologies, and Opsis Therapeutics entered into a strategic alliance to develop cell therapies for ocular diseases. A press release reported that this agreement gives BlueRock Therapeutics the option to license from the other two companies three retinal cell therapy programs focused on dry AMD and inherited retinal diseases containing human retinal pigment epithelial cells and photoreceptor cells.
ASCRS events
- Glaucoma Building Blocks, an educational series for comprehensive glaucoma management, begins May 25.
- The Virtual Park City Summit, a celebration of Alan Crandall, MD, will take place May 26 from 8:30–9:45 p.m. ET.
- The Challenging Cases in Cataract Video Symposium at the ASCRS Annual Meeting is accepting submissions through May 31.
- The “skip-the-line” deadline for the 2021 ASCRS Annual Meeting in Las Vegas, Nevada, July 23–27, is June 1. If you want your badge mailed to you, register and select the mailing option by this date.
Research highlights
- A prospective, randomized, controlled study published in the American Journal of Ophthalmology investigated the effects of LipiFlow (Johnson & Johnson Vision) on MGD and dry eye induced by cataract surgery. The study included 124 eyes of 124 patients who were randomized into a LipiFlow group or control. LipiFlow was administered 3 weeks before cataract surgery, and meibomian glands were evaluated before treatment and at 1 and 3 months postop. Tear film breakup time, corneal staining, and tear film lipid layer thickness were also measured. According to the research, the control group showed a significant decrease in meibomian gland expressibility, reduced meibum quality, reduced lipid layer thickness, and worsened corneal staining after cataract surgery. Dry eye symptoms also worsened in this group. The paper reported that the LipiFlow group showed improved meibomian gland patency and meibum quality, increased tear film breakup time, and reduced corneal staining. In addition, the study reported that patients who didn’t have MGD at baseline who received LipiFlow preop appeared to show less signs of MGD or dry eye induced by cataract surgery postop.
- A short report published in the journal Clinical Ophthalmology described a modified flanged intrascleral IOL fixation technique. The authors of this report noted the popularity of the Yamane technique, which eliminates the need for glue or sutures, but they stated that needing to dock IOL haptics into needles for externalization can be difficult. This report described docking of a second haptic externally at the main corneal incision. The authors stated that this technique does not require micro-forceps and that it could be safer and easier because the haptic is docked externally rather than in the eye.
Product news
- Glaukos entered into a license agreement with Santen Pharmaceutical for the PRESERFLO MicroShunt, obtaining exclusive commercialization rights in the U.S., Australia, New Zealand, Canada, Brazil, Mexico, and the rest of Latin America, as well as control over development activities in these territories.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.
Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor
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