EW Weekly, September 20, 2019

New Drug Application submitted for RVL-1201 to treat blepharoptosis
A New Drug Application has been submitted to the FDA for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution 0.1%, Vertical Pharmaceuticals) as a potential treatment for blepharoptosis. RVL is a once-daily formulation of oxymetazoline. It is believed to selectively target Muller's muscle and elevate the upper lid. If approved, it will be the first pharmacological treatment for blepharoptosis, according to the company's press release.

Primary endpoint met in Phase 2b study of wet AMD treatment OPT-302
The primary endpoint of mean visual acuity gain at 24 weeks compared to Lucentis (ranibizumab, Genentech) monotherapy was met by OPT-302 (Ophthea) in treatment-naïve patients with wet AMD, according to an Ophthea press release. The randomized, double-masked, sham-controlled clinical trial included 366 wet AMD patients who received two intravitreal doses of OPT-302 (0.5 mg and 2.0 mg) given once a month in combination with ranibizumab over 24 weeks compared with a control group that received 0.5 ranibizumab once a month. A mean of 14.2 letters of vision were gained from baseline on the Early Treatment of Diabetic Retinopathy Study eye chart at 24 weeks in the patients who received 2.0 mg OPT-302 combination therapy. That compared with a 10.8-letter gain in the control group. The 0.5 OPT-302 low-dose group had a similar outcome (+9.4 letters). Combination treatment with OPT-302 also demonstrated improvements across secondary endpoints, including a higher proportion of patients with stable vision. No safety risks were identified in the study. Additional analyses of the Phase 2b study results are ongoing. OPT-302 is a soluble form of vascular endothelial growth factor (VEGF) receptor 3.

Durability data announced from Phase 1b study of KSI-301 for wet AMD
Durability data for KSI-301 (Kodiak Sciences) for wet AMD shows all patients, who were treatment-naïve and followed for 12 months or longer after a loading phase, had a treatment-free period for 3 months or more, according to David Brown, MD, who announced the data at The Retina Society Annual Meeting in September. KSI-301 is an investigational therapy built on the company’s Antibody Biopolymer Conjugate Platform. It is designed to maintain drug levels in ocular tissues longer than existing agents, according to the company.

Data released from OPTIC Phase 1 trial’s first cohort for ADVM-022 for wet AMD
Twenty-four week clinical data from the first cohort of patients who received an intravitreal dose of ADVM-022 (Adverum Biotechnologies) for wet AMD found vision maintenance and improvements in retinal anatomy, with zero anti-VEGF rescue injections required through week 24, according to a company press release. The first cohort included six patients. The patients required frequent anti-VEGF injections previously to treat their wet AMD and maintain functional vision. The agent was safe and well tolerated. ADVM-022 is a gene therapy for wet AMD and diabetic retinopathy that uses a proprietary vector capsid carrying an aflibercept coding sequence under the control of a proprietary expression cassette.

Study: Methotrexate, mycophenolate mofetil perform similarly for noninfectious uveitis
In a head-to-head clinical trial, methotrexate and mycophenolate mofetil performed similarly in treating noninfectious uveitis, according to research published this month in JAMA. The First-line Antimetabolites for Steroid-sparing Treatment Uveitis Trial enrolled and randomly assigned 216 patients who had intermediate or posterior/panuveitis from around the globe. Patients were tapered to receive a maximum dose of 7.5 mg prednisone daily while also receiving 3 g of oral mycophenolate daily or 25 mg of methotrexate weekly. Doses were lowered as needed to reduce adverse side effects such as nausea. By 6 months, among those with intermediate uveitis, 67% of the participants in the methotrexate group and 57% of participants in the mycophenolate group had controlled their inflammation and tapered steroids. The difference between the two treatment groups was not statistically significant. In patients with posterior or panuveitis, 74% and 55% achieved control at 6 months in the methotrexate and mycophenolate groups, respectively.

Submit your nomination for the inaugural ASCRS Educator Award
The new ASCRS Educator Award recognizes an ASCRS member who has made education an enduring career priority. Nominees must: have demonstrated passion and commitment to education, leadership, and selflessness in the pursuit of expanding knowledge in the interest of improving patient outcomes; be an ophthalmologist focused on anterior segment surgery; have at least 5 years in practice; and be a current ASCRS member. Nominations are due by November 29. Find more information at ascrs.org/educatoraward.

Research briefs
  • Anterior chamber dimensions as determined by anterior chamber depth (ACD) and lower lens vault were significantly associated with diagnostic disagreement between anterior segment swept-source OCT (SS-OCT) and gonioscopy in angle closure assessment, reported Natalia Porporato, MD, and co-researchers. Their cross-sectional study included 2,027 phakic subjects age 50 or older. Gonioscopy and SS-OCT for the entire circumference of the angle were performed for each subject, and a two-quadrant closed gonioscopic definition was used. Angle closure was defined as iridotrabecular contact to the extent of 35% or higher, 50% or higher, and 75% or higher of the circumferential angle. Nearly 15% resulted in false positives when 50% or more of the angle circumference was closed using SS-OCT. Those eyes were significantly wider and deeper. A deeper ACD and lower lens vault were significantly associated with a false positive diagnosis; most of those cases had short (52.6%) or irregular (39%) iridotrabecular contact in SS-OCT images. The study is published in the British Journal of Ophthalmology.
  • A similar ACD and aqueous depth (AQD) were significantly correlated with more endothelial cell loss in patients with iris-fixated phakic IOLs, according to Alaa Eldanasoury, MD, and coresearchers. Ninety eyes from 57 patients were retrospectively enrolled, and optimal cut-off values for ACD and AQD were assessed during a mean follow-up of 11.8 years. The mean ECD change from baseline was -53.5% in eyes with a preop ACD of 3.20 mm or greater, -26% in eyes with an ACD of 3.21-3.49 mm, and -5.2% in eyes with an ACD of 3.50 mm or greater (P<.001). There was no significant endothelial cell loss in eyes with an ACD of 3.50 mm or greater, but 84% of eyes with an ACD of 3.20 mm or less had significant endothelial cell loss. A minimum ACD of 3.35 mm or an AQD of 2.75 mm was recommended for better long-term endothelial safety. The research appears in the Journal of Refractive Surgery.
  • A new assessment tool for simulation small-incision cataract surgery (SICS) had good face and content validity, reported William Dean, MD, and co-researchers. Their SICS Ophthalmic Simulated Surgical Competency Assessment Rubric (OSSCAR) was developed by an international group of experienced ophthalmologists. Both novice and competent surgeons from four countries were recorded performing surgery. Masked assessments were performed by four expert surgeons. When a panel of 12 international experts were asked if the OSSCAR represented surgical techniques and skills upon which trainees should be assessed, all respondents agreed or strongly agreed. Face validity was rated 4.60 out of 5.0. Final content validity was rated as 4.5. The new assessment tool could play a role in ophthalmic surgical education, the researchers concluded. The study is published in the Journal of Cataract & Refractive Surgery.

  • Product news
  • The TECNIS Synergy IOL (Johnson &amp; Johnson Vision) is now available for cataract surgery patients in Europe, Australia, and New Zealand, according to a company press release.

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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