PanOptix trifocal IOL granted CE mark
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The AcrySof IQ PanOptix trifocal IOL (Alcon, Fort Worth, Texas) has received the European CE mark, Alcon said in a news release. The PanOptix "is indicated for adult patients with and without presbyopia undergoing cataract surgery who desire near, intermediate and distance vision with increased spectacle independence."
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FDA agrees to altered endpoints in Rocket 2
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Aerie Pharmaceuticals (Irvine, Calif.) said the Food and Drug Administration has agreed in written and verbal communications that Aerie may change the primary endpoint range of its Rocket 2 study, a second phase 3 registration trial of glaucoma medication Rhopressa, a Rho kinase (ROCK) and norepinephrine transporter (NET) inhibitor.
The new primary endpoint will include patients with baseline intraocular pressures (IOPs) ranging from above 20 mm Hg to below 25 mm Hg; the previous endpoint had been 20-27 mm Hg. That larger range will now be a secondary endpoint. In the Rocket 1 trial, in the 20-25 mm Hg range, Rhopressa demonstrated non-inferiority to timolol and numerical superiority over timolol at the majority of time points.
Additional patients will not be recruited into Rocket 2, and Aerie expects 3-month results by the end of Q3 2015. Aerie plans to initiate Rocket 4 during Q3, along with the first Roclatan phase 3 registration trial (dubbed "Mercury 1"). If approved, Rhopressa would be the only once-daily product to specifically target the trabecular meshwork while simultaneously lowering episcleral venous pressure.
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AMD treatment AVA-101 demonstrates positive top line phase 2a results
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AVA-101, in development as a subretinal gene therapy injection for the treatment of neovascular age-related macular degeneration, showed an improvement on best corrected visual acuity (BCVA) compared with the control group and a positive trend in response rate (stable vision with few rescue injections) in a phase 2a study, developer Avalanche Biotechnologies (Menlo Park, Calif.) said in a news release. It met the primary safety and tolerability endpoint as well.
In the study, BCVA mean change from baseline showed a difference of 11.5 letters between AVA-101 (+2.2 letters) and control groups (-9.3 letters). Additionally, a significant number of AVA-101 treated subjects (42.9%) improved or maintained stable vision with 2 or fewer rescue injections compared with subjects in the control group (9.1%). Importantly, BCVA improvement of at least 10 letters with 2 or fewer rescue injections was observed in 23.8% of treated subjects and none of the control group patients.
The phase 2a study enrolled 32 subjects age 55 or older with wet AMD and randomized them to an AVA-101 treatment group (n=21) or a control group (n=11). Subjects in both groups received 2 ranibizumab injections at day 0 and week 4.
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Clearside Biomedical has 'favorable' phase
2 review with FDA
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Clearside Biomedical (Alpharetta, Ga.) announced a favorable end-of-phase 2 review with the Food and Drug Administration on its lead drug triamcinolone acetonide, administered via injection into the suprachoroidal space for the treatment of macular edema associated with non-infectious uveitis. Based on the discussion, Clearside will initiate a single, global pivotal phase 3 study that will enroll 150 patients in up to 50 U.S. and international sites.
Data from Clearside's completed phase 1/2 study showed improvement in best corrected visual acuity (BCVA) ranging up to 25 letters as measured on the Early Treatment of Diabetic Retinopathy Study eye chart. When measured at week 12, the average improvement in BCVA exceeded 2 lines of improvement while at week 26 the average was close to 3 lines of improvement; no patient experienced any meaningful increase in intraocular pressure.
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Bimatoprost insert shows promise in phase 1b study
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Helios, a bimatoprost ocular insert for the treatment of glaucoma, provided sustained reduction in intraocular pressure (IOP) for 6 months in a phase 1b study, developer ForSight Vision5 (Menlo Park, Calif.) said in a press release.
In this analysis of 27 subjects who met eligibility criteria, mean diurnal IOP at washout was 23.9 mm Hg, and a mean sustained diurnal IOP reduction of 4.7-6.5 mm Hg was observed for 6 months. There were no reported serious or unexpected ocular adverse events.
A phase 2 dose-ranging study (FSV5-004) is a prospective, randomized, double-masked, controlled study designed to evaluate the efficacy, safety, and dose response of 2 loading doses of the bimatoprost ocular insert compared to a control arm in subjects with open-angle glaucoma or ocular hypertension. Top-line results are expected during the second half of the year.
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Bascom Palmer researchers link common protein to glaucoma
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A team of Bascom Palmer Eye Institute researchers has discovered that the protein cochlin, most recognized in concentrated levels within the inner ear, is present in the eye and has an effect on glaucoma, the Miami-based university said in a press release. The team found that levels of cochlin, a protein product of the COCH gene, rise just prior to the elevation of intraocular pressure (IOP).
For these studies supported by National Institutes of Health (NIH) grants, Jianhua (Jay) Wang, MD, associate professor of ophthalmology, designed and built a proprietary optical coherence tomography instrument combining 2 different approaches (spectroscopic and magnetomotive) to detect the levels of cochlin.
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RESEARCH BRIEFS
- Positioning of the near add did not significantly affect objective or subjective visual function parameters in an asymmetric multifocal IOL, according to Deric W. de Wit, FRCOphth, and colleagues. The group retrospectively analyzed data from consecutive patients who had bilateral implantation of the Lentis Mplus LS-312 (Oculentis, Berlin), where one group received inferonasal near-segment placement (N=40 patients/80 eyes) and the other received superotemporal near-segment placement (n=38 patients/76 eyes). A +3 D reading add was used in all eyes. The mean 3-month spherical equivalent was −0.11 D±0.49 in the inferonasal group and −0.18±0.46 D in the superotemporal group. The mean postoperative uncorrected distance visual acuity (VA) was 0.14±0.10 logMAR and 0.18±0.15 logMAR, respectively. The mean monocular uncorrected near VA was 0.21±0.14 logRAD and 0.24±0.13 logRAD, respectively. The study is published in the Journal of Cataract & Refractive Surgery.
- A retrospective, clinical-pathological, interventional, consecutive case series evaluating the histopathological diagnoses, visual outcome, and complication rate of orbital biopsy in a U.K. tertiary referral center has found orbital biopsy serves as a safe diagnostic tool in managing orbital diseases. D.S.J. Ting and colleagues identified 166 orbital biopsies that occurred between July 2004 and June 2014 in Newcastle Eye Centre (Newcastle upon Tyne, U.K.). Of these, 86 patients (53.1%) were female and the mean age was 53.7±19.7 years. Of all the cases, orbital biopsies were performed unilaterally in 158 (97.5%) patients and bilaterally in 4 (2.5%) patients. The mean follow-up period was 2.2±2.3 years. The 2 most common histopathological diagnoses were non-specific inflammatory disease (62, 38.3%) and lymphoproliferative disease (40, 24.7%). None of the patients experienced ≥2 Snellen line visual loss. Overall, there was a <5% postoperative complication rate. The study is published in Eye.
- In a pediatric patient cohort, corneal collagen crosslinking (CXL) effectively stabilized uncorrected visual acuity, refractive indices, and keratometry values at 1 year, while improving best corrected visual acuity, according to L. McAnena and M. O'Keefe. They retrospectively evaluated medical records of 25 eyes (14 patients ≤18 years of age) treated with CXL from December 2009 to August 2013. Mean age at surgery was 16.2±1.6 years. Mean uncorrected visual acuity was 0.53±0.32 logMAR at baseline and 0.46±0.36 logMAR at 1 year (P=0.07). Mean preoperative best corrected visual acuity was 0.3±0.26 logMAR, which improved to 0.15±0.12 logMAR at 1 year (P=0.01). Baseline spherical equivalent and cylinder values were unchanged at 1 year. At 1 year, compared with preoperative Kmax values, 5 eyes (20%) showed regression; 13 eyes (52%) showed stabilization; and 7 eyes (18%) showed progression. There was a significant reduction in the mean thinnest corneal area from baseline (473.6±37.68 μm) to 6 months (424.55±70.2 μm), but this recovered at 1 year (452.82±53.5 μm). The study is published in the Journal of AAPOS.
NEW PRODUCT LAUNCHES- Bausch + Lomb (Bridgewater, N.J.) expanded its Trulign toric IOL line to 10.0-16.5 D (in 0.5 D steps), providing eyecare practitioners the full diopter range of the premium lens (from 10.0 D to 33.0 D) for their cataract patients, the company said.
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EyeWorld Weekly Update is edited by Stacy Majewicz 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: ASCRSOpinions 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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