EW Weekly, August 16, 2019

FDA does not approve dry eye treatment KPI-121, requests additional data
The U.S. FDA sent a complete response letter to Kala Pharmaceuticals for KPI-121 0.25%, saying that more efficacy data from an additional clinical trial are needed to support resubmission, according to a company press release. KPI-121 is designed for the temporary relief of signs and symptoms of dry eye disease. Kala is still enrolling patients in the Phase 3 STRIDE 3 clinical trial and expects that this trial will help provide the data needed in response to the FDA. Topline data from STRIDE 3 are estimated to be ready by the end of this year, with resubmission of the company’s New Drug Application in the first half of 2020. STRIDE 3 is a multicenter, randomized, double-blind, placebo-controlled, parallel-arm study that compares KPI-121 0.25% to placebo, with both dosed four times a day over 2 weeks in an estimated 900 patients with dry eye disease.

Primary endpoint met in study of OPT-302 for wet AMD
The primary endpoint was met in a Phase 2b study of OPT-302 (Opthea), a combination therapy for wet age-related macular degeneration (AMD). The primary endpoint was superiority in mean visual acuity gain at 24 weeks compared to Lucentis (ranibizumab, Genentech) monotherapy in treatment-naïve patients with wet AMD, according to an Opthea press release. The randomized, double-masked, sham-controlled trial included 366 wet AMD patients allocated to receive two intravitreal doses of OPT-302 (0.5 mg and 2.0 mg) given monthly in combination with Lucentis 0.5 mg over 24 weeks compared with a control group that received only Lucentis 0.5 mg. The patients receiving combination therapy with 2.0 mg of OPT-302 gained a mean of 14.2 letters of vision from baseline on the Early Treatment Diabetic Retinopathy Study eye chart at 24 weeks compared with 10.8 letters in the control group. The group receiving 0.5 mg of OPT-302 had a similar outcome to the control group. Those receiving OPT-302 had a higher proportion of patients with stable vision.

FDA clears IND application for QR-1123 for retinitis pigmentosa
The U.S. FDA has cleared the Investigational New Drug (IND) application for QR-1123, according to a press release from ProQR Therapeutics. The company now will start to enroll patients in a Phase 1/2 trial for the agent this year. QR-1123 is a first-in-class investigational oligonucleotide that addresses the underlying cause of vision loss associated with autosomal dominant retinitis pigmentosa due to P23H mutation in the rhodopsin gene. P23H mutation is the most prevalent mutation associated with this type of retinitis pigmentosa in the U.S., according to the company. The trial will initially include up to 12 adults and a single-dose escalation arm and a multiple-dose arm in which one intravitreal injection of QR-1123 or sham procedure will be given in one eye.

FDA approves EYLEA injection prefilled syringe
The U.S. FDA has approved the EYLEA injection prefilled syringe (aflibercept, Regeneron Pharmaceuticals), a 2 mg, single-dose, sterilized prefilled syringe. EYLEA is currently indicated to treat wet AMD, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

FDA approves generic dorzolamide hydrochloride ophthalmic solution
The U.S. FDA has approved a generic version of dorzolamide hydrochloride ophthalmic solution 2% (Alembic Pharmaceuticals).

Online registration for ASCRS and ASOA Combined Ophthalmic Symposium ends August 20
Don't miss your chance to attend the 2019 ASCRS and ASOA Combined Ophthalmic Symposium, being held August 23–25 at the JW Marriott Austin in Austin, Texas. Online registration ends Tuesday, August 20. Registration will be available onsite: Friday, August 23, 7:00 a.m.–6:00 p.m., Saturday, August 24, 6:30 a.m.–6:00 p.m., and Sunday, August 25, 7:00–10:30 a.m. You can view the Final Program online now. The ASCRS Ophthalmologist Program runs Saturday, August 24 from 8:00 a.m.–5:00 p.m. and Sunday, August 25 from 8:00–12:00 p.m. On Friday, August 23, an optional wet lab is being held from 3:00–5:00 p.m.

Research briefs
  • A prospective randomized cohort study found that the Nexis silicone corneal shield was safe, effective, and had faster visual recovery compared to a conventional bandage contact lens, but the new corneal shield may be less comfortable, reported Kristin Hirabayashi, MD, and coresearchers. In the 25 myopic patients included in the study, standardized bilateral wavefront-guided or wavefront-optimized PRK was performed. The patient’s dominant eye was randomized for the Nexis shield or a conventional bandage contact lens; the contralateral eye was given the other intervention. Researchers tracked uncorrected distance visual acuity (UDVA) and patient-reported outcomes until postop day 7. The logMAR UDVA was 0.04 at postop day 1 in the corneal shield group and 0.29 in the bandage contact lens group. At postop day 7, the mean UDVA was 0.09 in the corneal shield group and 0.23 in the bandage contact lens group. Greater pain, discomfort, foreign body sensation, and heavy eyelid were noted in the eye with the corneal shield during days 1 to 3. By postop day 7, there was no statistically significant difference in survey outcomes between the two groups. The research appears in the Journal of Cataract & Refractive Surgery. An analysis of factors that affect outcomes and time to recovery from malignant glaucoma found that early vitrectomy may reduce recovery time and that neodymium:YAG laser hyaloidotomy and oral carbonic hydrase inhibitors (CAIs) may lead to a larger reduction in IOP, reported Atalie Thompson, and coresearchers. Their retrospective case series included 64 eyes with malignant glaucoma (55 subjects). Among them, 87.5% needed surgical intervention. Vitrectomy was more likely to be successful in eyes with a history of fewer than three incisional surgeries, fewer than three glaucoma drops, and an IOP of 30 mm Hg or less. Recovery of anatomy, best visual acuity, and IOP occurred sooner if vitrectomy was performed within 30 days. The time to maximal improvement took significantly longer for IOP and best visual acuity than for anatomy. Although trabeculectomy may impede time to recovery from malignant glaucoma, oral CAIs might shorten the time to anatomic recovery. The study appears in the American Journal of Ophthalmology.
  • In a study comparing preoperative formula power calculations versus the intraoperative aberrometry ORA System (Alcon), intraoperative aberrometry led to more accurate spherical equivalent outcomes in eyes implanted with a low toric IOL, reported Robert Cionni, MD, and coresearchers. All eyes received the AcrySof IQ T3 IOL (Alcon). Analysis included two stages—hypothesis generation and confirmatory testing. Confirmatory endpoints were a comparison of the absolute prediction errors for intraop aberrometry for the implanted IOL compared with preop formula power calculations. The mean absolute intraop prediction error was significantly lower than preop prediction error. In eyes in which the power of the implanted IOL was different from the power of the preop planned lens, mean and median paired differences in prediction errors were greater, at –0.13 D and –0.15 D, respectively. The percentage of eyes with a prediction error of –0.50 D or less was significantly higher with intraop aberrometry (83.4%) than with use of the preop formula (76.5%). The study is published in Clinical Ophthalmology.
  • Several surgical techniques may be useful for strabismus surgeons to adopt to lower the bacterial load and reduce infection risk in patients, according to Malcolm Ing, MD, and coresearchers, who conducted a literature review of various infection types after strabismus surgery. Although endophthalmitis after strabismus surgery was uncommon, the visual results were usually devastating, they found. Adverse intraocular condition symptoms usually began by mean postop day 3, but a definitive diagnosis and treatment for endophthalmitis were not typically made until mean postop day 6. Surgeons should consider the preop use of povidone-iodine on the operative field and avoid scleral perforation during surgery, the researchers concluded. The review article appears in the Journal of Pediatric Ophthalmology and Strabismus.

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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