EyeWorld Weekly Update, January 4, 2019
- Imprimis Pharmaceuticals changes name to Harrow Health
- Nicox, Novaliq collaborate to develop NO-donating PDE5 inhibitors for glaucoma
- FDA accepts NDA for dry eye therapy KPI-121
- Results announced in MINIject's first-in-human trial 1 year post-surgery
- NDA submitted for Xipere for treatment of macular edema associated with uveiti
- Beaver-Visitec to acquire PhysIOL Group
Imprimis Pharmaceuticals changes name to Harrow Health
Imprimis Pharmaceuticals (San Diego) has changed its name to Harrow Health. "Our new name reflects our business model of creating, investing in, and growing a diversified portfolio of healthcare businesses that meet the needs of healthcare providers and patients across America," said CEO Mark Baum in a press release. Harrow's wholly owned subsidiaries include ImprimisRx and Park Compounding. The company also has equity interests and royalty rights in Eton Pharmaceuticals, Surface Pharmaceuticals, Melt Pharmaceuticals, Mayfield Pharmaceuticals, and Radley Pharmaceuticals.
Nicox, Novaliq collaborate to develop NO-donating PDE5 inhibitors for glaucoma
Nicox (Sophia Antipolis, France) announced that it will focus its research on topic nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors and soluble guanylate cyclase stimulators and that it has entered a research collaboration with Novaliq GmbH (Heidelberg, Germany) to develop new topical ophthalmic formulations of Nicox's NO-donating PDE5 inhibitors based on the water-free enabling EyeSol technology from Novaliq, the latter of which lowers IOP. If successful, Nicox will test the ophthalmic formulations in established preclinical models.
FDA accepts NDA for dry eye therapy KPI-121
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KPI-121 0.25% (Kala Pharmaceuticals, Waltham, Massachusetts), designed for temporary relief of signs and symptoms of dry eye disease using a 2-week course of therapy, according to a Kala press release. The FDA has a set target action date of Aug. 15, 2019, under the Prescription Drug User Fee Act. If approved, the agent is expected to be the first product indicated for temporary relief of dry eye signs and symptoms, including dry eye flares.
Results announced in MINIject's first-in-human trial 1 year post-surgery
One year post-surgery, the MINIject (iSTAR Medical, Wavre, Belgium) was safe and effective at reducing IOP and easing medication burden, according to a company press release. The trial led to a mean 32.6% IOP reduction, to a mean of 15.6 mm Hg at 1 year. Seventy-five percent of patients could stop using their topical medication and remained medication-free at 1 year. No serious ocular events occurred; no patients required further glaucoma surgery. The prospective, open, international, multicenter study included 25 patients with mild to moderate uncontrolled primary open angle glaucoma. The study is focused on the safety and performance of the device from baseline to 6 months and then up to 2 years of follow-up.
NDA submitted for Xipere for treatment of macular edema associated with uveiti
An NDA has been submitted to the U.S. FDA for Xipere (Clearside Biomedical, Alpharetta, Georgia), designed to treat macular edema associated with uveitis. Xipere is a proprietary suspension of triamcinolone acetonide formulated for the back of the eye via suprachoroidal injection. It is the company's first investigational treatment to reach NDA submission.
Research briefs
- A new drug delivery system that provides sustained delivery of anti-scarring agent decorin resulted in corneal opacity reductions within 16 days in a murine model of Pseudomonas keratitis, according to Lisa Hill and fellow researchers. The addition of hrDecorin led to a restoration of corneal epithelial integrity with minimal stromal opacity endorsed by reduced alpha-smooth muscle actin, fibronectin, and laminin levels. This drug delivery system could be a potential noninvasive anti-fibrotic treatment for patients with microbial keratitis, particularly when corneal transplantation is not available, the researchers concluded. Their work appears in Regenerative Medicine.
- There was no statistically significant difference between conventional phacoemulsification and femtosecond laser-assisted cataract surgery (FLACS) in a single-center, prospective, randomized, interventional, case-controlled trial, according to Harry Roberts, MSc, and fellow researchers. In the study, 400 eyes of 400 patients were randomized to receive conventional phaco or FLACS. Visual acuity, refraction, central cornea thickness, central foveal thickness, endothelial cell loss, and intraop and postop events were measured. Mean uncorrected distance visual acuity was 0.15 logMAR after both types of surgery. The increase in central corneal thickness was 13 microns and 15 microns after conventional phaco and FLACS, respectively. Endothelial cell loss was 9.7% and 10.7%, respectively. The rate of posterior capsule rupture was 3% and 0%, respectively. The percentage of patients with posterior capsule rupture was the only significant difference between the two treatment modalities. Manifest refraction spherical equivalent error was -0.14 D after conventional phaco and -0.12 D after FLACS (P=0.74). The study appears in the Journal of Cataract & Refractive Surgery.
- When performed by experienced surgeons, phaco in patients age 90 or older improves visual acuity as effectively and safely as it does in younger patients, according to Taku Toyama and coresearchers in their retrospective study. The study included 138 (group 1) and 152 (group 2) eyes in patients age 90 and older versus a group of patients younger than 80, all of whom had senile cataracts and had phaco and IOL implantation between 2014 and 2016. Intra- and postop complications were compared, as were best corrected visual acuity (BCVA) at 1 and 3 months. Multiple regression analysis was used with variables of age, cataract grades, sex, and history of diabetes mellitus and hypertension. There were similar intraop and postop complication rates between the two groups. After researchers adjusted for the difference in cataract grades, multiple regression analysis showed that BCVA improvement was equally favorable in both groups at 1 and 3 months, although it was less favorable at 3 months in patients with a history of diabetes mellitus (P=0.042). The study appears in BMC Ophthalmology.
- Age may be a possible risk factor for severe Acanthamoeba keratitis (AK), reported Machiko Shimmura-Tomita and fellow researchers, who focused on risk factors and clinical signs for severe AK. Researchers reviewed 10 cases of AK and compared patient age, time required for diagnosis, visual acuity on first visit, and history of steroid eye drop use. The eyes were divided into a severe versus a mild group. In the severe group, one eye required therapeutic keratoplasty, and three eyes had a poor visual acuity (<0.2) at the last visit. In the mild group, six eyes had a good prognosis with a visual acuity of 1.2 on the last visit. Patients were older in the severe group. A history of steroid eye drop use was found in all eyes in the severe group and in 67% of eyes in the mild group. In the severe group, one patient was diagnosed with diabetes mellitus. Also in the severe group, Staphylococcus epidermis was detected by palpebral conjunctival culture in one eye. The presence of keratoprecipitates was found in all severe AK eyes. The study is published in Clinical Ophthalmology.
This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.
EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, 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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