AdaptDx, the first instrument to provide a practical and objective measurement of dark adaptation function, has been granted the CE mark, said developer MacuLogix (Hummelstown, Pa.). Impaired dark adaptation is a sensitive, early marker of age-related macular degeneration (AMD) and other macular dystrophies, the company said. AdaptDx is an AC-powered, automated adaptometer designed to evaluate the time for retinal adaptation to darkness after exposure to light. MacuLogix expects to start selling the device in 2016.
|
|
The Food and Drug Administration has accepted a New Drug Application (NDA) for Vesneo (latanoprostene bunod ophthalmic solution 0.024%), an intraocular pressure-lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension, co-developers Bausch + Lomb (Bridgewater, N.J.) and Nicox (Sophia Antipolis, France) said in a news release. If approved, Vesneo will be the first nitric oxide donating prostaglandin receptor agonist available for glaucoma.
The FDA has set a Prescription Drug User Fee Act action date of July 21, 2016.
|
First p3 registration trial of Roclatan underway
|
|
Mercury 1, the first phase 3 registration trial for Roclatan, a novel once-daily, quadruple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, is now enrolling patients, developer Aerie Pharmaceuticals (Irvine, Calif.) said in a press release. Roclatan is a fixed-dose combination of Rhopressa and latanoprost; Rhopressa is a Rho kinase and norepinephrine transporter inhibitor.
Aerie anticipates total enrollment of approximately 690 patients in this 3-arm 1-year safety study with a 90-day efficacy readout. The range for the primary endpoint evaluates patients with maximum baseline IOPs ranging from above 20 to below 36 mm Hg; 90-day efficacy results are expected in about a year.
|
RegenRx enrolls first patient in NK study
|
|
The first patient has been enrolled in a phase 3 clinical trial with RGN-259 (Thymosin beta 4), a sterile, preservative-free eye drop formulation developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders, developer RegeneRx (Rockville, Md.) said in a news release.
The NK trial is a double-masked, placebo-controlled trial being conducted at 8 sites, which include major U.S. medical centers. The trial will enroll approximately 46 patients with chronic stage 2 and 3 NK, and is expected to be completed toward the end of the first quarter of 2016. RGN-259 is also in a phase 2b/3 clinical trial in the U.S. for patients with dry eye syndrome. |
X-82 p1 results show promise
|
|
A phase 1 open-label study of orally administered X-82 in 35 adult patients with wet age-related macular degeneration (AMD) showed promise, said developer Tyrogenex (Needham, Mass.). X-82 showed an overall trend toward higher visual acuity of +4.3 letters of the Early Treatment Diabetic Retinopathy Study chart, and a trend toward decreased foveal thickness of -48 µm at 24 weeks (average of all patient data up to injection or dropout). Of the 25 patients completing 24 weeks on X-82, 15 required no intravitreal injections of anti-VEGF and had a mean visual acuity improvement of +5.3 letters. X-82 was generally well tolerated, with 25 of 35 patients completing the full 24-week treatment period.
X-82 inhibits both VEGF and PDGFR, and Tyrogenex believes X-82 targets the basic mechanisms of neovascular eye diseases, including angiogenesis, fibrosis, and inflammation. X-82 is currently being evaluated for wet AMD and solid tumors.
|
|
RESEARCH BRIEFS
- Trainees were more proficient at assessing their own competence at the global indices of cataract surgery rather than task-specific components, according to a trainee self-assessment by E.J. Casswell and colleagues. A prospective, blinded, single-center comparative study of ophthalmology trainee surgeons recruited 16 junior trainees (150-499 cataract operations) and 16 senior trainees (>500 cataract operations). Senior trainees performed statistically better than junior trainees at all task-specific and global Objective Structured Assessment of Cataract Surgical Skill (OSACSS) indices, apart from draping (p=0.23) and overall score (p=0.09). Overall, trainees were better at assessing their OSACSS performance in global indices such as tissue handling, iris protection, and overall speed. They were worse at assessing their performance in task-specific indices, particularly use of the phacoemulsification probe and second instrument. Comparing the 2 trainee groups, senior trainees had a higher level of agreement with the assessor in more OSACSS indices (15/19) than junior trainees (4/19). The study is published in the British Journal of Ophthalmology.
- A moderate reduction in intraocular pressure is achievable with both cyclophotocoagulation (CPC) and cyclocryocoagulation (CCT), with CCT tending to produce a greater reduction in pressure, according to I. Gorsler and colleagues. In this retrospective cohort study, 184 eyes of 112 patients in whom cyclodestructive surgery was performed as a primary surgical procedure were examined. CPC was performed on 133 eyes and CCT on 51 eyes. On average, a reduction in IOP was observed after both of the cyclodestructive procedures (CPC: -1.55±2.50 mm Hg, p<0.05; CCT: -2.33±3.06 mm Hg; p<0.05). The average difference in IOP reduction between the two procedures (0.78 mm Hg) proved to be statistically insignificant (p=0.08). In contrast, greater patient age and higher preoperative IOP values were found to be highly significant influencing factors. In 45% and 70% of the patients treated with CPC and CCT, respectively, IOP was reduced by at least 20%, with no increase in medication or with a reduction in medication of at least one substance with no increase in pressure. CPC and CCT produced an average loss of visual acuity of more than 2 lines in 10. The study is published in Graefe's Archives for Clinical and Experimental Ophthalmology.
- Motorized diamond burr polishing of the corneoscleral bed during primary pterygium excision in comparison with manual polishing requires significantly less surgical time with better uncorrected visual acuity (UCVA), decreased astigmatism, and greater surgically induced astigmatism (SIA) at 6 months, which indicates greater astigmatic correction, according to P. Chikkanayakanahalli Narasimhaiah and colleagues. The interventional observer-masked controlled trial randomized 40 patients to polishing of the corneal bed using a crescent blade (group 1, n=20 eyes), and 20 eyes to a motorized diamond burr (group 2). There was no difference in the 2 groups with respect to mean age, gender, preoperative UCVA, best spectacle-corrected visual acuity (BCVA), spherical equivalent, mean astigmatism, tear function tests like tear break-up time, tear film meniscus height, Schirmer I and II, pterygium dimension, and conjunctival autograft size. Mean intraoperative surgical time was significantly more in group 1 (16.9±2.85 min) as compared with 12.25±1.88 min in group 2. Postoperatively, there was a statistically significant reduction in astigmatism and improvement in UCVA, BCVA, and spherical equivalent in all eyes. No difference was found in mean epithelial defect healing time, UCVA, BCVA, astigmatism, tear film break-up time, Schirmer I and II, and tear meniscus height at 6 months between 2 groups; however, significantly better UCVA was found in group 2 at 3 months (P=0.04). SIA was significantly more in group 2 as compared with group 1 at 6 months (P=0.0006). The study is published in Eye & Contact Lens.
|
|
|
|
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. |
|
|
|
|
