EU grants orphan designation to neurotrophic keratitis drug
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Recombinant human nerve growth factor (rhNGF) has been designated an orphan drug for the treatment of neurotrophic keratitis by the European Medicines Agency, developer Dompé (Milan) said in a press release. The mechanism of action of rhNGF aims to restore innervation in the corneal area, which may have been damaged due to various pathological causes capable of resulting in neurotrophic keratitis, Dompé said.
The REPARO phase 1/2 clinical trial is the first to test the efficacy and safety of rhNGF for ophthalmic use in patients affected by the disease. This randomized, double-masked, vehicle-controlled parallel group study was conducted in 39 centers in 9 European countries and enrolled adult patients with unilateral neurotrophic keratitis with corneal lesions of stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer) who did not respond to currently available medical treatments. Results are expected in 2016, the company added.
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Pfizer, Allergan agree to merge
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Pfizer (New York) and Allergan (Dublin) have agreed to merge in a deal estimated at $160 billion, creating the world's largest pharmaceutical company by sales. The deal is expected to close in the second half of 2016. Pfizer chief Ian Read will be chairman and CEO while Allergan chief Brent Saunders will be president and COO.
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Dextenza enters phase 3 for allergic conjunctivitis
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Enrollment has begun for a second phase 3 study of Dextenza (sustained release dexamethasone), 0.4 mg intracanalicular depot for the treatment of allergic conjunctivitis, developer Ocular Therapeutix (Bedford, Mass.) said. Dextenza is administered by a physician as a bioresorbable intracanalicular depot and designed for drug release to the ocular surface for up 30 days. The prospective, U.S.-based multicenter, 1:1 randomized, double-masked, vehicle-controlled trial is enrolling patients who exhibit chronic signs and symptoms of allergic conjunctivitis and will use a placebo vehicle punctum plug as the comparator. The primary endpoint to be evaluated is ocular itching at day 7 following insertion.
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Glaukos submits travoprost/iDose IND
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Glaukos (Laguna Hills, Calif.) has submitted an Investigational New Drug application to the U.S. Food and Drug Administration seeking authorization to study its travoprost intraocular implant with the iDose delivery system for investigational use in the reduction of elevated intraocular pressure (IOP) in patients with glaucoma. The implant is designed for removal after drug depletion.
Injected through a clear corneal incision and secured in the anterior chamber, "the iDose is designed to continuously elute therapeutic levels of medication from within the eye for extended periods of time" the company said. The proposed phase 2 study will evaluate various doses of travoprost in the iDose to determine elution rates compared to topical timolol maleate ophthalmic solution, 0.5%. |
Postop inflammation leads to AcrySof recall in Japan
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Alcon (Fort Worth, Texas) is recalling 89,042 units of IOLs in Japan, due to an increase in reports of postoperative inflammation among patients who received the AcrySof IQ Toric lens, according to news reports.
The Food and Drug Administration said that Alcon sent a "FDA Notification-Update to Recall" letter on Oct. 1 to consignees in Japan who have received the affected lenses in order to initiate recovery of the device. Under the earlier recall, 43,651 units were affected. This latest updated recall is because of continued inflammation reports. The recall affects the AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9.
Alcon said in an earlier press release that "the investigation has determined that the increase in cases of postoperative inflammation in Japan is correlated to a combination of the unique surface properties of the Japan IOLs and common processing steps that are used only for AcrySof ReSTOR, ReSTOR Toric, and high-cylinder Toric IOLs (SNA6T6-SNA6T9). Alcon has already identified and is implementing process improvements to prevent recurrence of this issue." The company reiterated that the manufacturing process in Japan is unique to that country and involves a different curing process compared to IOLs manufactured for other markets.
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RESEARCH BRIEFS
- Compared with repeat donor penetrating keratoplasty (PK), the Boston type I keratoprosthesis (KPro) had a greater likelihood of maintaining visual improvement without higher risk of postoperative glaucoma, according to S. Ahmad and colleagues. Their systemic review and meta-analysis identified 17,128 articles in the PK analysis. After screening, 26 studies (21 case series and 5 cohort studies) were included in the review. Pooled analysis of the 26 unique studies demonstrated a 42% likelihood of maintaining 20/200 or better at 2 years after repeat PK, compared with an 80% probability with KPro implantation. The probability of maintaining a clear graft at 5 years was 47%, after repeat PK, whereas the probability of retention of the KPro at 5 years was 75%. The rate of progression of glaucoma at 3 years was 25% (95% CI, 10%-44%) after repeat PK and 30% in the KPro cohort. The study is published in Ophthalmology online ahead of print.
- Diurnal intraocular pressure (IOP) fluctuation in asymptomatic primary angle-closure suspects (PACS) was less than that in treated primary angle-closure glaucoma (PACG) subjects and was at least comparable to that in treated primary angle closure (PAC) and primary open-angle glaucoma (POAG) subjects, a new study in Eye reports. S. Srinivasan and colleagues evaluated 117 eyes (29 PACS, 30 PAC, 28 PACG, and 30 POAG) in a cross-sectional study. All patients underwent hourly IOP measurements with Goldmann tonometer from 0800 to 1700 hours. Subjects with PAC and PACG had laser peripheral iridotomy at least 2 weeks prior to the inclusion. IOP fluctuation differed between the groups (P=0.01; Kruskal-Wallis Test). Post hoc Mann-Whitney U-tests showed significantly less IOP fluctuation in PACS compared with PACG (P<0.01). Peak office-hour IOP was observed in the morning in untreated subjects and in the early afternoon in treated subjects. A stepwise linear regression model identified the presence of peripheral anterior synechiae, thickness of lens, large vertical cup-to-disc ratio, and PAC category as significant predictive factors associated with office-hour IOP fluctuation.
- "Promising results" in terms of safety, efficacy, and predictability in eyes with high degrees of myopia were found after using wavefront-guided LASIK and a new-generation Hartmann-Shack aberrometer in patients with high myopia, according to Steven C. Schallhorn, MD, and colleagues. In their retrospective, non-comparative case series, data on eyes that had wavefront-guided LASIK for high myopia and myopic astigmatism (spherical equivalent [SE] between −6.00 D and −10.25 D, up to 5.00 D of cylinder) were analyzed (n=621). Outcomes included visual acuities, refractive outcomes, vector analysis of refractive cylinder, and patient satisfaction. The mean manifest SE reduced from −7.28 D±1.05 preoperatively to −0.09±0.44 D at 3 months. The mean manifest cylinder changed from −1.02±0.82 D to −0.27±0.33 D postoperatively. The percentage of eyes achieving an uncorrected distance visual acuity of 20/20 or better was 82.4% monocularly and 92.5% binocularly. The mean correction ratio of refractive cylinder was 1.02±0.48, and the mean error of angle was −0.29±14.56 degrees. A postoperative questionnaire revealed high satisfaction with the outcomes of the procedure, with low scores for night vision phenomena. The study is published in the Journal of Cataract & Refractive Surgery.
NEW PRODUCT BRIEF
- Patient Education Concepts (PEC, Houston) launched its Internet-based informed consent service at this year's American Academy of Ophthalmology annual meeting. With MyEye Consent, cataract and refractive counselors can assign, monitor, and document the viewing, understanding, and completion of any one of PEC's informed consent videos. If the patient has questions, he/she can enter them at the end of the program. An alert is sent to the assigning counselor who can choose to answer questions prior to the surgery or on the patient's surgery day. Practice personnel can also determine if patients have completed the informed consent forms on the day of surgery and scan the form into the patient's medical records.
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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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