EW Weekly, January 18, 2019
- Supplemental New Drug Application filed for Dextenza
- Investigational NDA for AR-1105 reviewed and accepted by FDA
- ProQR, FDA reach agreement on Phase 2/3 pivotal trial for Leber's congenital amaurosis 10 treatment
- Price of generic and older drugs increase along with branded drugs
- Branded nepafenac has better results post-cataract surgery
- Be a part of the new Winning Pitch Challenge Symposium at the 2019 ASCRS/ASOA Annual Meeting
Supplemental New Drug Application filed for Dextenza
Investigational NDA for AR-1105 reviewed and accepted by FDA
ProQR, FDA reach agreement on Phase 2/3 pivotal trial for Leber's congenital amaurosis 10 treatment
Price of generic and older drugs increase along with branded drugs
Branded nepafenac has better results post-cataract surgery
Be a part of the new Winning Pitch Challenge Symposium at the 2019 ASCRS/ASOA Annual Meeting
The Winning Pitch Challenge is currently accepting Round 1 submissions. Selected submissions are advanced to Round 2 and paired with a mentor on a rolling basis.
*Shark Tank is a registered trademark of Sony Pictures Television and is not affiliated with these services.
Research briefs
- Descemet membrane endothelial keratoplasty (DMEK) had good postop final visual acuity results in eyes with poor preop vision caused by corneal pathology, reported Silvia Schrittenlocher and coresearchers. Their analysis of 1,162 consecutive eyes of 1,184 patients focused on eyes with DMEK alone or combined with cataract surgery (triple-DMEK). They also analyzed pre- and postop visual acuity values at 1, 3, 6, and 12 months after transplantation. A significant correlation was found between pre- and postop visual acuity after triple-DMEK after 6 and 12 months. A preop visual acuity of below 20/100 led to more delayed and reduced final visual acuity results after 12 months. However, when defining an increase in visual acuity as greater than 0.1 logMAR as clinically relevant, researchers could not show any clinically relevant significant difference in the time needed to recover final visual acuity and in final visual acuity. No significant difference for preop visual acuity values above 20/40 occurred. "The chance to reach postoperative visual acuity above 20/25 is 40% for preoperative visual acuity of 20/200, 50% for preoperative visual acuity of 20/60, and greater than 60% for preoperative visual acuity of 20/40," the researchers wrote. There appears to be a benefit in performing DMEK early, before visual acuity is below 20/100, the authors concluded. The study is published in Graefe's Archive for Clinical and Experimental Ophthalmology.
- Meibography results appear to be a sensitive early indicator for meibomian gland disease (MGD), reported Muhammed Yasin Adil and coresearchers. Their cross-sectional study included 538 patients with MGD and 21 healthy controls. Meibomian gland loss was tracked using meibography images of upper and lower lids that were graded on a scale of 0 (lowest degree of loss) to 3. The mean upper and lower lid meibogrades were significantly higher in patients with MGD compared with controls. Sensitivity and specificity of the meibograde as a diagnostic parameter for MGD were 96.7% and 85%, respectively. Meibomian gland morphology correlated significantly but weakly with several clinical parameters. Morphologic analysis of meibomian glands can show an early stage of MGD and is a complementary clinical parameter with diagnostic potential, the researchers concluded. The study is published in the American Journal of Ophthalmology.
This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.
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 Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.
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