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Avedro (Waltham, Mass.) has resubmitted its New Drug Application (NDA) for riboflavin ophthalmic solution/KXL System to the U.S. Food and Drug Administration, and now anticipates an application action date in April 2016. If approved, the system would be the first FDA-approved therapeutic treatment for progressive keratoconus and corneal ectasia following refractive surgery.
In February, the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel voted in support of the NDA for both applications, but a month later the FDA issued a complete response letter asking questions about the design of the company's KXL device and its equivalence to the clinical study device.
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FDA wants more studies on lifitegrast before approval
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Lifitegrast will not be approved for the signs and symptoms of dry eye without additional clinical studies, the Food and Drug Administration (FDA) said in a complete response letter to developer Shire (Lexington, Mass.). Shire has recently completed a phase 3 study of lifitegrast, OPUS-3, that will be the basis of Shire's response to the letter if results are positive, the company said. OPUS-3 results are expected next month.
"If the study is positive, we plan to refile our lifitegrast submission in the first quarter of 2016, and will remain on track for the planned lifitegrast launch next year," said Flemming Ornskov, MD, CEO of Shire.
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Ampio needs confirmatory study on DME drug, FDA says
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After meeting with the FDA to discuss diabetic macular edema (DME) treatment Optina (ultra-low dose danazol), developer Ampio (Englewood, Colo.) will need to perform a confirmatory study on patients with DME who are refractory to the currently available drugs, the company said. If the confirmatory study is successful, it would qualify Optina as a rescue medication for patients who have failed currently available therapies.
In this study, placebo will be the comparator, as patients had already failed anti-vascular endothelial growth factor injections; power calculations suggest the study will need about 80 patients, 40 each in the Optina and placebo arms. Improved vision as measured by best corrected visual acuity will be the primary endpoint, Ampio noted, and they expect the study duration to be no more than 12 months.
Safety does not need to be an endpoint as danazol is already established at doses more than 10 times higher than the Optina dose, Ampio said.
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Trabodenoson trial starts dosing
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MATRx-1, the first pivotal phase 3 trial of trabodenoson for the treatment of glaucoma, has begun dosing participants, developer Inotek Pharmaceuticals (Lexington, Mass.) said in a press release. Trabodenoson is a first-in-class selective adenosine mimetic under investigation for reduction of IOP.
MATRx-1 is a randomized, double-masked, placebo-controlled trial of trabodenoson in approximately 335 patients diagnosed with primary open-angle glaucoma or ocular hypertension that will assess the efficacy, safety, and tolerability of the compound over 3 months of treatment. The primary endpoint will be the reduction of IOP, and the study will contain a timolol 0.5% arm to validate the sensitivity of the patient population. Three doses of trabodenoson will be administered: 1,000 mcg once daily, 1,500 mcg twice daily, and 2,000 mcg once daily.
The trial will enroll patients with IOP between 24 mm Hg and 34 mm Hg. Top-line results are expected in the fourth quarter of 2016.
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Health Canada approves Ziemer's FEMTO LDV
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Health Canada has approved the FEMTO LDV Z8 to provide capsulotomy and lens fragmentation, Ziemer (Port, Switzerland) announced. The femtosecond laser for refractive cataract surgery is already CE marked and is awaiting U.S. regulatory approval.
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RESEARCH BRIEFS
- Long-term follow-up results show that bag-in-the-lens (BIL) IOL implantation is a safe, well-tolerated approach for treating pediatric cataract with a very low rate of visual axis reopacification and a low rate of secondary interventions for other postoperative complications, according to Jan Van Looveren, MD, and colleagues. This prospective case series followed 31 children (46 eyes) with at least 5 years of follow-up post-implantation. Patients ranged in age from 2 months to 14 years. The mean refraction at the end of follow-up was −1.99 Dą3.70 (SD). In bilateral cases (n=15), a corrected distance visual acuity (CDVA) of >0.5 was attained in 86.7% and a CDVA of 1.0 was achieved in 56.7%. In unilateral cases (n=16), 31.2% achieved a CDVA of better than 0.5 but none obtained a CDVA of 1.0. Inadequate BIL IOL positioning was the cause of all four cases of visual axis reopacification. The study is published in the Journal of Cataract & Refractive Surgery.
- Opacification of the IOL can be a vision-threatening late complication after Descemet's stripping endothelial keratoplasty (DSEK), according to C.P. Nieuwendaal, MD, and colleagues. They retrospectively analyzed 160 eyes that underwent DSEK between 2003 and 2013; the first patient to present with reduced vision as a result of opacification occurred in 2008. Opacification was seen in 8 eyes (5%) and was diagnosed between 4 and 24 months (mean 9.6 months) after DSEK. The mean Snellen corrected distance visual acuity was 0.6 before opacification and 0.3 (SD, 0.2; range, 0.02-0.6) after opacification of the IOL occurred. The IOL material was hydrophilic acrylic in all patients. An IOL exchange was performed in four eyes. The study is published in Cornea.
- Ocular surface disease and its complications were associated with more frequent device removal in patients implanted with the Boston type 1 keratoprosthesis (KPro), according to a new study. Sumayya Ahmad, MD, and colleagues retrospectively evaluated 48 eyes that underwent explantation of the KPro due to complications between January 2003 and August 2014 at 5 participating tertiary eyecare centers in the U.S. Ocular surface disease was significantly more common in eyes that required a device explantation, compared to those who retained the device (p<0.001). Sixty-seven percent of eyes (24/36) achieved visual acuity (VA) ≥20/200 after the repeat KPro. The probability of these 24 eyes maintaining VA ≥20/200 after the repeat KPro was 87% at 1 year and 75% at 2 years. Predictors of the ability to maintain vision ≥20/200 following surgery were a better last-recorded vision before explantation (p=0.0002) and better vision immediately after repeat KPro (p<0.001). The study is published online ahead of print in the American Journal of Ophthalmology.
NEW PRODUCT BRIEF
- New World Medical (Rancho Cucamonga, Calif.) will launch its Kahook Dual Blade (KDB) at the 2015 American Academy of Ophthalmology (AAO) meeting. The KDB, invented by Malik Kahook, MD, is engineered to excise trabecular meshwork (TM) tissue through a clear corneal incision as small as 1.2 mm. It features a tip to pierce the TM, a ramp that puts the TM on stretch as the KDB is advanced, and parallel blades that excise the stretched tissue, the company said.
- Oculus has launched the JENVIS Dry Eye Report software module for use with its Keratograph 5M, the company said. A complete report summarizes all the data from a dry eye questionnaire, a slit lamp measurement of lid parallel conjunctival folds, and four measurements performed with the Keratograph 5M, including an analysis of the degree of bulbar redness using R-Scan, measurements of tear meniscus height and tear film break-up time, and a meibography.
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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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