EW Weekly, August 9, 2019

Glaukos acquires Avedro
Glaukos announced that it has entered a merger agreement with Avedro. Glaukos will acquire Avedro in an all-stock transaction. The deal is subject to Avedro stockholder and regulatory approvals. The merger is expected to be complete by the fourth quarter of this year, according to a Glaukos press release.

Stowe Pharmaceuticals formed by Harrow Health
Harrow Health has formed a new subsidiary, Stowe Pharmaceuticals. Stowe has entered into an agreement with TGV Health to acquire the worldwide rights of STE-006 (Zian), an anti-microbial molecule for ophthalmic and otic uses, according to a Harrow press release. Adenoviral conjunctivitis is slated to be the primary indication for Stowe's initial drug candidates. Secondary indications will likely be mixed bacterial-viral infections, keratitis, endophthalmitis, and corneal ulcers. In initial preclinical models, STE-006 was significantly more effective than current conventional therapies against various bacterial and viral pathogens, including strains of MRSA and herpes simplex virus, according to the company. U.S. FDA approval for STE-006 will be pursued via the 505(b)(1) pathway as a New Chemical Entity.

Topline results announced from THEIA-1 Phase 2b/3 clinical study for dry eye agent
Topline results from the THEIA-1 Phase 2b/3 clinical study evaluating TOP1630, an anti-inflammatory kinase inhibitor targeting dry eye, were announced by TopiVert. THEIA-1 was a multicenter, randomized, double-masked, placebo-controlled study that focused on the efficacy and safety of TOP1630 0.1% ophthalmic solution compared with placebo over a 4-week period. The study included 202 adult patients with moderate to severe dry eye disease. The study's primary endpoints—efficacy of TOP1630 0.1% compared to placebo at day 29 for ocular grittiness and total ocular surface staining—were not met. However, the drug showed statistically and clinically relevant improvements on multiple prespecified endpoints compared to placebo. The agent also was safe and well tolerated, with few adverse drug reactions. Greater effects may be seen with longer duration of treatment, according to the company press release.

Presbyopia clinical trial data for STAAR Surgical lens submitted to DEKRA
STAAR Surgical submitted data to DEKRA, the company's European notified body, from its European pivotal clinical trial for the EVO+ Visian ICL with Aspheric Optic, an EDOF lens that corrects or reduces myopia or hyperopia and presbyopia, according to a company press release. If approved, the lens could be commercially available by second quarter 2020 in countries that recognize the CE mark, according to the company. The lens met its primary endpoint in the trial, which was defined as achievement of monocular uncorrected near visual acuity of 20/40 or better at approximately 40 cm at 6 months after implantation in 75% or more of implanted eyes.

ILUVIEN approved in Australia to treat DME
ILUVIEN (Alimera Sciences) has been approved in Australia to treat diabetic macular edema in patients previously treated with corticosteroids who did not have a clinically significant rise in IOP. Alimera Sciences’ distribution partner in Australia, Specialised Therapeutics, will commercialize the drug throughout Europe.

European Medicine Agency validates marketing application for abicipar for AMD
The European Medicines Agency (EMA) has validated the marketing authorization application for abicipar, a DARPin therapy to treat neovascular age-related macular degeneration, according to a press release from Molecular Partners. The validation indicates that the submission is complete enough to begin the formal review process, according to the release. Molecular Partners has formed a strategic partnership with Allergan for abicipar.

Positive opinion received in Europe for use of ranibizumab to treat ROP
Novartis received a positive opinion from the Committee for Medicinal Products for Human Use of the EMA for the use of ranibizumab (Lucentis) to treat preterm infants with retinopathy of prematurity. The European Commission will review the opinion and deliver a final decision within 3 months, according to a Novartis press release. If approved, ranibizumab will be the first and only pharmacological therapy indicated for retinopathy of prematurity in this patient population. The regulatory submission is based on results from the Phase 3 RAINBOW trial.

Research briefs
  • Pharmaceutical products not used during phaco result in high financial and environmental costs, according to Jenna Tauber, MD, and coresearchers, in their qualitative evaluation of four U.S. surgical sites: a private ambulatory care center, a private tertiary care center, a private outpatient center, and a federally run medical center for veterans. Researchers collected data on routine phaco procedures without vitreous loss or other complications; they also collected data on the volume or weight of medications remaining after surgery. The total and mean costs of medications per case and month were calculated, and environmental effects were estimated using input-output life cycle assessment methods. A cumulative mean 83,070 of 183,304 mL per month (45.3%) of pharmaceuticals were left unused by weight or volume among all cites. The annual unused product cost estimates were $195,200 per center. There was a larger percentage of unused eye drops (65.7% by volume) compared with injections (24.8%) or systemic medications (59.9%). The unused quantities also resulted in unnecessary potential emissions at each center. If the study findings can be substantiated and shown to be generalizable across the U.S., it may be valuable to reduce the costs, the researchers concluded. The study appears in JAMA Ophthalmology.
  • No significant differences were found between visual acuity using IOL repositioning and IOL exchange 2 years after surgery; both methods were equally efficient and safe, reported Marius Dalby and coresearchers. Their prospective, randomized, parallel-group trial focused on the long-term efficacy and safety of two operation methods for late in-the-bag IOL dislocation and included 104 eyes over a 3-year period. The eyes were assigned to either a group for IOL repositioning by scleral suturing (n=54) or a group for IOL exchange by retropupillary fixation of an iris-claw IOL (n=50). Patients were examined preoperatively and at 6 months and 1 and 2 years postop. The mean corrected distance visual acuity (CDVA) after 2 years was 0.20 logMAR units in the repositioning group and 0.22 logMAR in the exchange group (P=.69). In 76% of all patients, a CDVA of 20/40 or better was reached. In the repositioning group, 12% of eyes had cystoid macular edema compared with 15% in the exchange group. No endophthalmitis or retinal detachment occurred. The study is published in the American Journal of Ophthalmology.
  • The use of numeric modeling to optimize surgical parameters for arcuate keratotomy led to more reliable postop astigmatism, which limited the risk for overcorrection, reported Oskar Truffer, MSc, and coresearchers. Their computation modeling study used a new approach to plan arcuate keratotomy based on personalized finite element simulations. An optimization algorithm was used to determine the incision parameters that met the surgeon’s requirements and preserved the orientation of the astigmatism. Virtual surgeries were performed on patients to compare the simulation-based approach with results based on the Lindstrom and Donnenfeld nomograms and with intrastromal interventions. In 28 patients, personalized simulation reproduced the surgically induced change in astigmatism. The Lindstrom nomogram resulted in low postop astigmatism but frequent overcorrections (20%). The Donnenfeld nomogram and intrastromal incisions resulted in a small amount of overcorrection (1.5%) but a wider spread in astigmatism. The numeric parameter optimization approach led to postop astigmatism values that closely matched the target astigmatism and kept the number of overcorrections low (less than 1.5%). The study appears 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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