Inotek moving forward with trabodenoson
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After what the company called a "positive" end-of-phase 2 meeting with U.S. regulators, Inotek (Lexington, Mass.) will initiate phase 3 studies on glaucoma medication trabodenoson, a first-in-class selective adenosine mimetic designed to restore the eye's natural pressure control mechanism. Inotek expects to begin the first phase 3 study during the 4th quarter. The trial design for the first pivotal study is a 5-arm superiority trial that will include 3 doses of trabodenoson, and a primary efficacy endpoint of the study is the reduction of intraocular pressure that is statistically superior as compared to placebo. A comparator arm of timolol will also be included for study validation, but not for statistical comparison. The overall program will enroll 1,300 patients; phase 2 studies indicated trabodenoson's efficacy improved over time.
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Study links CRAO, cardiovascular risk factors
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Researchers have found that central retinal artery occlusion (CRAO) indicates cardiovascular risk factors at higher rates than originally believed.
To better understand cardiovascular risk factors in CRAO patients, a group of German researchers examined data from the European Assessment Group for Lysis in the Eye (EAGLE) study, which included standardized medical and neurologic examinations. The study included 77 patients, 54 men and 23 women, who had a mean age of 62.2 years. All study participants were required to answer a standardized questionnaire regarding their medical history and to undergo both physical and neurologic examinations.
Cardiovascular risk factors or events were newly diagnosed in 78% of study participants. Among these, the most frequently discovered risk factor was ipsilateral carotid artery stenosis, which was present in 40% of the participants, compared to 4.1% in the general population. Carotid ultrasound was the most relevant diagnostic procedure in CRAO patients.
"Although there are limited means to treat the eye after acute non-arteritic CRAO, it is important to work in close cooperation with the primary physician and colleagues from internal medicine and neurology to check every CRAO patient for cardiovascular risk factors," said study coauthor Nicolas Feltgen, MD, Georg-August University, Goettingen, Germany. "Acute loss of vision due to CRAO or partial retinal arterial occlusions or amaurosis fugax should be treated as promptly as patients with ischemic stroke to identify cardiovascular risk factors and prevent stroke in the population at risk." |
Allergan provides first responders with eye drops
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Allergan (Dublin, Ireland) has launched the Refresh America campaign, where every purchase of Refresh Optive eye drops leads to the company's donating a bottle to select first responder groups nationwide. Allergan has pledged a minimum product donation with an approximate retail value of $250,000, regardless of the number of eligible products sold during the campaign period, which runs from August 1, 2015-July 31, 2016.
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RESEARCH BRIEFS
- Moscow Eye Microsurgery Complex in Russia (MICOF) keratoprosthesis (Kpro) is an effective alternative for patients with ocular burn with corneal blindness, according to L. Wang and colleagues. Their retrospective, non-competitive, interventional case series analyzed 90 eyes of 90 patients with ocular burns that underwent MICOF Kpro surgery at the Chinese People's Liberation Army General Hospital between April 2000 and December 2012. The mean age of patients was 40.26±12.18years, and the mean duration after ocular trauma was 4.8±6.2years. The mean follow-up period was 58.22±36.28 months. Eighty patients were followed for ≥1year and 73 eyes (81.11%) achieved the best corrected visual acuity of 20/200 or better, and 39 eyes (43.33%) achieved best corrected visual acuity of ≥20/40. The common complications were glaucoma, corneal melt, and conjunctiva overgrowth. There was no significant difference in the effectiveness of the implants among the different causes of injuries, including acid, alkali and thermal burns. The study is published online ahead of print in the British Journal of Ophthalmology.
- Femtosecond laser-assisted astigmatic keratotomy (AK) was effective in reducing irregular astigmatism after penetrating keratoplasty (PKP), according to new research in the Journal of Cataract & Refractive Surgery. A. Fadlallah and colleagues evaluated 62 eyes of 57 patients over a mean follow-up of 28 months. Preoperatively, the mean corrected distance visual acuity (CDVA) was 0.51±0.26 logMAR and the mean uncorrected distance visual acuity (UDVA) was 0.98±0.24 logMAR; 6 months postoperatively, the mean CDVA and UDVA improved to 0.40±0.22 logMAR and 0.60±0.2 logMAR, respectively (both P<.01). The mean preoperative absolute astigmatism was 7.1±1.72 D; 6 months postoperatively, the mean refractive astigmatism was 2.6±2.4 D (P<.001). Overcorrection occurred in 12 eyes. Refinement of the treatment nomogram for femtosecond laser-assisted AK for high astigmatism after PKP remains a major issue, the group concluded.
- Toric IOL calculations using estimated total corneal astigmatism based on the anterior-to-posterior corneal cylinder power ratio provided a more appropriate toric IOL cylinder power than calculations using SimK astigmatism, according to Youngsub Eom, MD, and colleagues. They evaluated 928 eyes (928 patients) and 20 cataract patients (20 eyes) implanted with a toric IOL. Linear regression analysis parameters (β0 and β1) of the relationship between the simulated keratometry cylinder (CylSimK) and posterior corneal cylinder power of reference subjects were used to calculate the estimated posterior corneal astigmatism (-[β1×CylSimK+β0] @ 90). Estimated posterior corneal astigmatism was determined to be -(0.15×CylSimK+0.22) @ 90 in eyes with with-the-rule astigmatism, -(0.05×CylSimK+0.27) @ 90 in oblique astigmatism, and -0.27 @ 90 in against-the-rule astigmatism. The median magnitude of the predicted residual astigmatism error calculated using estimated total corneal astigmatism (0.30 cylinder diopters) was significantly smaller than that calculated with SimK (0.50 cylinder diopters). The study is published in the American Journal of Ophthalmology.
NEW PRODUCT BRIEFS
- Adaptica (Padua, Italy) will launch its VisionFit Wearable Adaptive Refractor at the European Society of Cataract & Refractive Surgeons (ESCRS) meeting in September. The VisionFit is an electronic, tunable, solid state, mobile and wearable system of adaptive lenses that performs a subjective sight examination and replaces the need for trial glasses and the manual/electronic phoropter.
- Nextech (Tampa, Fla.) released IntelleChart 6.6.2 "specifically designed to meet the specific documentation demands of ophthalmologists, helping ensure compliance as they transition to ICD-10 without sacrificing efficiency," the company said.
- Opternative (Chicago) launched an online, ophthalmologist-issued prescription service for spectacles and contact lenses. By using a computer and smartphone, consumers can take an approximately 25-minute eye exam in their home and receive a prescription within 24 hours to use at any online or neighborhood optical retailer. The "clinically validated online exam" has been "proven statistically comparable to a traditional in-office refractive eye exam," the company said.
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EyeWorld Weekly Update is edited by Stacy Jablonski and Michelle Dalton.
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 D. Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Steven C. Schallhorn, MD, refractive editor; and John A. Vukich, MD, international editor
For sponsorship opportunities or membership information, contact: ASCRS*ASOA * 4000 Legato Rd. * Suite 700 * Fairfax, VA 22033 * Phone: 703-591-2220 * Fax: 703-591-0614 * Email: ASCRS
Opinions expressed in EyeWorld Weekly Update do not necessarily reflect those of ASCRS*ASOA. Mention of products or services does not constitute an endorsement by ASCRS*ASOA. |
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