Mesencephalic astrocyte-derived neurotrophic factor (MANF) has been granted orphan drug status for the treatment of retinitis pigmentosa (RP) by the U.S. Food and Drug Administration, developer Amarantus (San Francisco) said in a press release.

An investigational new drug application (IND) to conduct phase 2 clinical testing of NS2 for the treatment of noninfectious anterior uveitis was submitted to U.S. regulators in mid-December, developer Aldeyra Therapeutics (Lexington, Mass.) announced.

The European Committee for Medicinal Products for Human Use recommended a conditional marketing authorization for Holoclar (Chiesi Farmaceutici S.p.A., Parma, Italy), a living tissue equivalent intended for the treatment of adult patients with moderate to severe limbal stem cell deficiency due to ocular burns, according to documents on the agency's website.

The "ex-vivo expanded autologous human corneal epithelial cells containing stem cells" acts by replacing damaged corneal cells, including limbal stem cells responsible for continuous regeneration and maintenance of the corneal epithelium. By re-establishing a reservoir of stem cells in the eye, Holoclar initiates normal corneal cell growth and maintenance, the European agency said.

The Food and Drug Administration has granted breakthrough therapy designation for Lucentis (ranibizumab, Genentech, South San Francisco) for the treatment of diabetic retinopathy (DR). The FDA previously accepted the supplemental Biologics License Application for Lucentis and granted the medicine priority review for the treatment of DR, Genentech said.

According to the 2014 Prevent Blindness "Future of Vision: Forecasting the Prevalence and Costs of Vision Problems" report, the number of Americans with glaucoma will jump 50% by 2032 and 92% by 2050 from the current 2.8 million affected by the disease.

Medical treatment costs related to glaucoma and disorders of the optic nerve are also projected to skyrocket in the coming years, the Chicago-based group predicts. More than $6 billion is spent annually on the disease currently. In 2032, the number jumps to $12 billion a year and by 2050, the annual medical treatment cost is estimated to be $17.3 billion, Prevent Blindness said in a news release.

RESEARCH BRIEFS

• LASIK for high myopia is safe over the long term, but significant myopic regression with time was detected in a 15-year follow-up study. Jorge L. Alió, MD, and colleagues conducted a retrospective/prospective case series on 40 patients (40 eyes) with a mean age of 51.08±6.67 years (range 41-60 years) with high myopia (−6.00 to −18.00 D). All patients underwent LASIK with the VISX 20/20 excimer laser. During the follow-up, a significant increase in the dioptric power of all keratometric variables was detected (P≤.028, Friedman test), the most notable increase occurring between 3 months and 1 year (P≤.005). At 15 years, 46.15% of the eyes were within ±1.00 D of the attempted spherical equivalent and 64.10% were within ±2.00 D. The uncorrected distance visual acuity at 15 years was 20/25 or better in 43.59% of eyes and 20/40 or better in 64.10% of eyes. The postoperative corrected distance visual acuity was significantly better than preoperatively (P<.001). The postoperative complications were minor (ectasia occurred in 1 eye). The study is published in the Journal of Cataract & Refractive Surgery.
• Descemet's membrane endothelial keratoplasty (DMEK) seems to be successful in restoring visual acuity even in vitrectomized eyes, according to a study. E. Yoeruek and colleagues reviewed 20 DMEK cases: Seven eyes had a history of anterior vitrectomy, and 13 eyes had a history of complete removal of the vitreous body. The mean age was 62.9 years, and mean follow-up after DMEK was 11.2 months. The preoperative mean best corrected visual acuity (BCVA) was 1.4±0.5 logMAR and increased to 1.0±0.5 logMAR after 4 weeks (P=0.0290). After 6-month and 12-month follow-up, BCVA was 0.8±0.6 logMAR (P=0.0055) and 0.6±0.3 logMAR (P=0.0001), respectively. In 13 cases, significant intraoperative complications were experienced. In the immediate postoperative period, iatrogenic primary graft failure was reported in 2 eyes (2/20). In 4 eyes, late graft failure was observed. Two eyes had exacerbation of preexisting glaucoma. Mean preoperative endothelial cell density was 2301±159 cells per square millimeter; postoperative follow-up visits at 6 and 12 months showed a decrease to 1,398±161 cells/mm2 and 1,241±155 cells/mm2, respectively. The study is published in Cornea.
• The aspheric Synchrony Vu accommodating IOL (Abbott Medical Optics, Abbott Park, Ill.) provided good visual performance at a range of distances without affecting quality of vision and with minimal safety considerations, according to E.F. Marques and A. Castanheira-Dinis. They prospectively evaluated the Synchrony Vu in 74 patients (148 eyes) undergoing cataract surgery. At 6 months, 89% of the eyes were within ±1.0 D spherical equivalent refraction. Mean binocular uncorrected and distance corrected visual acuity was 20/20 at far (0.00±0.11 logMAR and -0.06±0.08 logMAR, respectively), 20/20 at intermediate (0.01±0.13 logMAR and -0.01±0.10 logMAR, respectively), and 20/25 at near (0.10±0.14 logMAR and 0.14±0.15 logMAR, respectively). Mesopic contrast sensitivity was within normal limits. Seventy-eight percent of the patients had no spectacles and 70% had no dysphotopsia. One eye had IOL repositioning within 1 month of surgery. The study is published in Clinical Ophthalmology.