EW Weekly, December 20, 2019
- FDA approves teprotumumab for thyroid eye disease
- First patient enrolled in Phase 4 trial of Acthar Gel for severe keratitis
- Trial begins for new cohesive OVD
- NEI launches trial for patient-specific stem cell therapy for geographic atrophy
- FDA: STAAR can initiate trials for lenses
- Roche completes acquisition of Spark Therapeutics
December 20, 2019
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Volume 25 ,
Number 46
FDA approves teprotumumab for thyroid eye disease
The U.S. FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to approve teprotumumab (Horizon Therapeutics), a fully human monoclonal antibody to treat thyroid eye disease. The FDA currently is evaluating a Biologics License Application for teprotumumab. The agent is one of fewer than five medications to receive Priority Review, Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA, according to a Horizon Therapeutics press release. The Prescription Drug User Fee Act action date for teprotumumab is March 8, 2020. Although FDA leaders will consider the committee’s vote as they review the Biologics License Application, they are not obligated to follow its recommendation. Submission of the Biologics License Application is based on results from the Phase 3 OPTIC trial.
First patient enrolled in Phase 4 trial of Acthar Gel for severe keratitis
The first patient has been enrolled in a Phase 4 study for Acthar Gel (repository corticotropin injection, Mallinckrodt) for severe keratitis. The Phase 4 study is a multicenter, multi-dose, open-label study that has a target enrollment of 30 patients. Subjects with severe keratitis will be treated with Acthar Gel 1 mL subcutaneously twice a week for 12 weeks. The initial treatment will be followed by a taper to Acthar 1 mL subcutaneously once a week for 2 weeks, followed by 0.5 mL subcutaneously once a week for 2 weeks. Acthar is approved by the FDA for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa. Researchers will determine the proportion of patients who improved on the Impact of Dry Eye on Everyday Life scale and the proportion of patients who showed improvement from baseline in the scale’s symptom bother score at 12 weeks, according to a Mallinckrodt press release.
NEI launches trial for patient-specific stem cell therapy for geographic atrophy
The National Eye Institute (NEI) announced a clinical trial to test a patient-specific stem cell-based therapy to treat geographic atrophy, according to a press release. It is the first trial in the U.S. that will use replacement tissues from patient-derived induced pluripotent stem cells, according to the press release. As part of the therapy, a patient’s own blood cells will be used and converted in a lab into induced pluripotent stem cells programmed to become retinal pigment epithelial cells. Twelve patients with advanced-stage geographic atrophy will take part in the Phase 1/2a trial and will receive the induced pluripotent stem cell-derived retinal pigment epithelial implant in one eye. Patients will be closely monitored for at least a year. If early safety is confirmed, later study phases will include more patients to examine efficacy.
FDA: STAAR can initiate trials for lenses
STAAR Surgical has given enough data to support a human clinical study in the U.S. of the EVO/EVO+ VISIAN Implantable Collamer Lens for Myopia and the EVO/EVO+ VISIAN Toric Implantable Collamer Lens for Myopia with Astigmatism, according to a STAAR press release, citing an FDA letter dated December 6. Company leaders plan to begin the trial in the first quarter of 2020 and include 300 subjects with a primary endpoint at the 6-month follow-up.
Research briefs
- Treatment with cenegermin (recombinant human nerve growth factor) had higher rates of corneal healing compared with vehicle in neurotrophic keratopathy, reported Stephen Pflugfelder, MD, and coresearchers. Their multicenter, randomized, double-masked trial was completed at 11 sites in the U.S. and randomized 48 patients 1:1 to cenegermin 20 micrograms/ml or vehicle eyes, six drops daily for 8 weeks of masked treatment. Follow-up continued for 24 weeks. The primary endpoint was healing of the neurotrophic lesion after 8 weeks. At week 8, there were statistically significant differences in corneal healing. Using a conventional assessment of corneal healing, 70% of the cenegermin-treated patients and 29.2% of the vehicle-treated patients had less than 0.5 mm of lesion staining. Using a conservative assessment, corneal healing also reached statistical assessment at week 8. Cenegermin-treated patients had statistically significant lowering of lesion size and disease progression rates during masked treatment. The drug was also well tolerated. The study appears in Ophthalmology.
- Endothelial cell loss after phaco is acute and stabilizes after 3 months in eyes with open angle glaucoma (OAG), reported Jonathan Lass, MD, and coresearchers. However, endothelial cell loss after phaco plus the CyPass Micro-Stent (Alcon) implantation continues for at least 5 years. The researchers’ study focused on long-term changes in corneal endothelial cells after phaco with or without supraciliary Micro-Stent implantation in eyes with OAG and visually significant cataract. In August 2018, Alcon voluntarily withdrew the CyPass Micro-Stent from the market due to safety concerns. This study focused on 282 patients from the COMPASS trial who had Micro-Stent implantation plus phaco or phaco alone (67 patients). Preop endothelial cell densities in the Micro-Stent group were similar to those in the control groups. The endothelial cell loss at months 48 and 60 were higher in the Micro-Stent group than the control group. By month 60, the mean percentage of endothelial cell density changes were –20.4% in the Micro-Stent group and –10.1% in the control group. Nine adverse events occurred, including three eyes with transient focal corneal edema and four eyes that required Micro-Stent trimming. The study appears in Cornea.
- Femtosecond laser-assisted arcuate keratotomy is a safe and effective method to correct astigmatism during cataract surgery and demonstrated stability of correction for at least a year post-surgery, reported Denise Visco, MD, and coresearchers. Their retrospective case series examined case records of patients with preexisting corneal astigmatism from 0.5 to 2.0 D. Corneal astigmatism, refractive astigmatism, and uncorrected and corrected distance visual acuities (UDVA/CDVA) were among the study parameters analyzed at 3 months postop. Among the case records of 189 eyes of 143 patients, postop refractive astigmatism was lowered significantly compared with preop corneal astigmatism to 0.14 D from 0.92 D (P<.001). Nearly 96% of eyes had a postop refractive astigmatism of 0.5 D or less. The mean surgically induced change along the preop steep axis was –0.59 D; the change along the orthogonal axis was 0.01 D. After surgery, 90.5% of eyes had an astigmatism angle of error of 15 degrees or less. Postop mean UDVA and CDVA were 0.09 and 0.02 logMAR, respectively. There was stability at 12 post-surgery. No intraop or postop arcuate keratotomy-related events were observed. The study is published in the Journal of Cataract & Refractive Surgery.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.
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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