EW Weekly, May 10, 2019

Novartis to acquire dry eye treatment Xiidra
Novartis has entered into an agreement with Takeda Pharmaceutical to acquire dry eye treatment Xiidra (lifitegrast ophthalmic solution) 5% from Shire Pharmaceuticals in a $5.3 billion deal. Subject to regulatory approvals, the deal is expected to close the second half of this year.

ARMOR Study: No decrease seen in coagulase-negative staphylococci
Although there’s been a general decrease in methicillin resistant Staphylococcus aureus, the same decrease has not occurred with coagulase-negative staphylococci (CoNS), according to results from the recently updated results from the Antibiotic Resistance Monitoring in Ocular MicRoorganisms (ARMOR) study, Bausch + Lomb announced. For the study, clinically relevant isolates of S. aureus, coagulase-negative staphylococci, Streptococcus pneumoniae, Pseudomonas aeruginosa, and Haemophilus influenzae from ocular infections were collected and subjected to antibiotic susceptibility testing. The recently released results included resistance trends collected since 2009. For the 2018 preliminary update, a total of 414 isolates were collected from 15 U.S. participating sites. Resistance rates for staphylococci were similar to 2017 rates, including marked resistance to azithromycin, oxacillin/methicillin, and ciprofloxacin. Among CoNS, there was resistance to trimethoprim and tobramycin. Multidrug resistance was seen in 30% of S. aureus and 40% of CoNS. Isolates from S. pneumoniae were resistant to azithromycin and oral penicillin, with no resistance to fluoroquinolones.

HORIZON trial: Long-term use of surgery, medications for glaucoma reduced
At 3 years, 73% of patients in the HORIZON pivotal study for the Hydrus Microstent (Ivantis) were medication-free, compared with 48% of patients in the cataract-only arm, according to results shared by Ivantis. For patients who were using only one medication when entering the study, 81% remained medication-free compared with 48% in the cataract-only arm. Among the Hydrus patients, 0.6% had subsequent invasive surgery for glaucoma versus 3.9% in the study arm. The overall safety of Hydrus was similar to cataract surgery alone, including endothelial cell density stability from year 2 to year 3. HORIZON is the largest prospective, randomized, controlled trial to date for a microinvasive glaucoma surgery device, according to Ivantis. The study included 556 patients among 38 centers in nine countries.

Enrollment begins for Phase 3 trial for SYD-101
Enrollment is now underway for a Phase 3 multicenter trial of SYD-101 (Sydnexis), a treatment designed to lower myopia progression in children. The company’s placebo-controlled STAAR study will include 800 patients between ages 3 and 14 and will test the safety and efficacy of two dosage strengths of SYD-101.

Last patient dosed in Phase 3 SOLACE trial
The last patient has been dosed in the Phase 3 SOLACE trial for topical ocular reproxalap (Aldeyra Therapeutics) in patients with noninfectious anterior uveitis. SOLACE is a randomized, double-masked, parallel-group, vehicle-controlled clinical trial, with a primary outcome measure of time-to-cure without rescue therapy. Results are slated to be announced in the second half of this year.

Santen, Glaukos enter collaboration and distribution agreement for MicroShunt in the U.S.
Santen has entered into a multi-year agreement that designates Glaukos as the exclusive distributor of the MicroShunt in the U.S. market, according to a press release from both companies. The MicroShunt is currently under investigation to help treat primary open-angle glaucoma. If the device is approved, product launch is expected next year, according to the press release.

Betaliq established to leverage EyeSol technology for glaucoma
Novaliq and BLP Management Group have formed a new company called Betaliq to help leverage EyeSol technology. The new company’s pipeline has two preservative-free glaucoma drug candidates based on new-in-class and best-in-class beta-blocker molecules using water-free EyeSol (Novaliq) technology, according to a press release. The two EyeSol based products are approved in Europe; two active Investigation New Drug applications are in late stage in the U.S.

Leiters integrated into Besse Medical’s Inventory Management Systems
Leiters and Besse Medical have entered into a national agreement to provide ophthalmic medications compatible with Besse Medical’s inventory management systems, CubixxMD and PODIS Plus. The new agreement enables Leiters’ medications to arrive individually serialized, lot-tracked, and integrated into the Besse inventory system with no additional printing, labeling, or processing, according to a company press release.

Patient enrollment complete in epi-on CXL Phase 3 trial
Enrollment is completed in the Phase 3 clinical trial ACP-KXL-308, a multicenter, randomized, sham-controlled study of epithelium-on corneal crosslinking that uses the latest generation ultraviolet light source from Avedro, supplement oxygen to enhance crosslinking, and a new drug formulation to penetrate the epithelial layer. The study is underway at 14 centers in the U.S. with more than 275 eyes and focuses on the treatment of progressive keratoconus.

Roclatan launches in the U.S.
Roclatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, a once-daily IOP-lowering drop for patients with glaucoma or ocular hypertension, has launched in the U.S. market, according to a press release from Aerie Pharmaceuticals.

Research briefs
  • In a study that compared the outcomes of an image-guided system and intraoperative aberrometer use with surgeon’s standard of care to correct astigmatism using toric IOLs or corneal incisions, there was no statistically significant difference in the mean spherical equivalent refraction by group (P=.51), reported Kerry Solomon, MD, and coresearchers. The prospective case series randomly assigned contralateral eyes having uneventful cataract surgery and astigmatic correction to surgeon’s preferred standard of care or preop planning using VERION and the ORA System with VerifEYE+ (Alcon) and femtosecond laser-assisted cataract surgery. The primary outcome was residual refractive astigmatism at 3 months. At 3 months, the IOL in 4 eyes (11%; two in each group) was more than 10 degrees of absolute orientation from the intended orientation. Toric IOLs resulted on average in almost 0.25 D less cylinder than corneal astigmatic incisions (P<.01), with no between-group differences. The study is published in the Journal of Cataract & Refractive Surgery.
  • In a retrospective case series, segmented axial lengths were up to 0.29 mm longer in short eyes and 0.50 mm shorter in long eyes, reported Li Wang, MD, PhD, in a study that focused on the difference between segmented axial length and the displayed axial length using an optical low-coherence reflectometry biometer. The study also compared the refractive prediction errors calculated using the segmented and displayed axial lengths. The mean absolute prediction error was calculated with the displayed axial length and segmented using six IOL power formulas: Olsen, Barrett Universal II, Haigis, Hoffer Q, Holladay 1, and Sanders-Retzlaff-Kraff. A total of 4,992 eyes from 4,992 patients were included in the theoretical study, along with 1,758 eyes from 1,758 patients in the refractive prediction error comparison. Axial length differences correlated negatively with the displayed axial lengths. Mean absolute prediction errors were significantly lower using segmented axial lengths for all formulas except the Olsen in the entire group and the long eye subgroup and for the Holladay 1 and Hoffer Q short eye subgroup. The research is published in Ophthalmology.
Product News
  • The U.S. FDA has approved the RingJect (OPHTEC USA), a single-use injector that is preloaded with the OPHTEC Capsular Tension Ring.
  • The LENSAR Laser System with Streamline IV capabilities has received U.S. FDA clearance. This expands the platform’s capabilities to include the creation of micro radial incisions to treat corneal conditions post-cataract 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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