Purpose: Several concerns have arisen with biosimilars in terms of immunogenicity, safety issues, loss of efficacy, and extrapolation to other indications. The study aim was to evaluate the efficacy of SB5, an adalimumab biosimilar, in noninfectious uveitis (NIU). Design: Retrospective nonrandomized study. Methods: Data from patients with refractory NIU treated with SB5 (Imraldi, Biogen) were analyzed at baseline, 3 months after SB5 initiation and at the last follow-up in terms of uveitis relapses, occurrence of retinal vasculitis, resolution of uveitic macular edema (UME), best-corrected visual acuity, glucocorticoids (GCs)-sparing effect and drug survival. Results: Uveitis relapses decreased from 121 relapses/100 patients/year in the 12 months before SB5 initiation to 4 relapses/100 patients/year during the first 12 months of treatment (P = 0.0004). Uveitis was inactive in 46/47 eyes at the end of the study period. The number of eyes with active retinal vasculitis decreased during the study period (P < 0.0001). At baseline, 6 eyes presented UME, whereas no eye had UME at the last follow-up. Mean best-corrected visual acuity increased from 7.7 ± 3.41 at baseline to 8.9 ± 2.46 at the last follow-up (P = 0.0045). Mean GCs daily dosage decreased from 18.33 ± 10.33 mg at baseline to 5.75 ± 2.29 mg at the last follow-up (P = 0.018). The cumulative SB5 retention rate was 91.8% at both 12- and 20-month follow-up. Conclusions: SB5 biosimilar is effective in NIU by drastically reducing uveitis relapses and the occurrence of retinal vasculitis. Moreover, SB5 biosimilar improved visual acuity, allowed a significant GCs-sparing effect and showed an excellent drug retention rate.
Variants in the X-linked retinitis pigmentosa GTPase regulator gene (RPGR) and, specifically, in its retinal opening reading frame-15 isoform (RPGRORF15) may cause rod-cone (RCD), cone, and cone-rod dystrophies (CDs and CRDs). While RPGR-related RCDs have been frequently evaluated, the characteristics and progression of RPGR-related CD/CRDs are largely unknown. Therefore, the goal of our work was to perform genotype–phenotype correlations specifically in RPGRORF15-related CD/CRDs. This retrospective longitudinal study included 34 index patients and two affected relatives with a molecular diagnosis of RPGR-related CD/CRDs. Patients were recruited at the “Quinze-Vingts” Hospital, Paris, France and screened for mutations in RPGRORF15 at the Institut de la Vision, Paris, France. We identified 29 distinct variants, of which 27 were truncating. All were located in the 3′ half of the RPGRORF15 transcript. Twenty of them were novel. Fifteen subjects were affected by CD, the remaining had CRD. When analyzing the longitudinal data, a progressive decline in visual acuity (VA) was noted, with more than 60% of the patients reaching VA ≥ 1 LogMar in the best eye after the fifth decade of life. To our knowledge, this is the largest described study of a cohort of CD/CRD patients affected by RPGRORF15 variants. Longitudinal data showed a rapidly progressive disease, possibly locating an optimal window of intervention for future therapies in younger ages.
The aim of this study was to evaluate a new femtosecond laser application for refractive corneal lenticule extraction with suction control and computerized regulation of centration and alignment (Ziemer CLEAR).Methods: This was a retrospective, consecutive, noncomparative case series study. Patients undergoing CLEAR for spherical equivalent (SE) between 23 and 210 D, evaluating SE, defocus equivalent, refractive astigmatism, visual acuity, and centration at 10 months were evaluated in the study.Results: Fifty-three eyes of 42 patients (mean age 40.4 6 8.6 years) were included, with preoperative SE 25.99 6 1.49 D and mean corrected distance visual acuity (CDVA) of 0.05 6 0.07 logMAR. With no suction losses, an intact lenticule was extracted in all eyes. In 6 eyes, peripheral adhesion was resolved by lenticulerrhexis, and in 1 eye, the incision was opened by a crescent blade. Moderate interface inflammation occurred in 3 eyes. At day 1, in the 42 eyes with uneventful surgery, the mean CDVA was 20/27, whereas in the 11 eyes with extra surgical manipulations, it was 20/36 (P= 0.04). At 10 months, for the 53 eyes, the mean uncorrected distance visual acuity was 0.05 6 0.09 logMAR; in 37 eyes (70%), it was 20/25 or better; and the mean CDVA was 0.04 6 0.06 logMAR. Eight eyes (15%) lost 1 logMAR line. The mean SE was 20.13 6 0.15 D. The mean defocus equivalent was 0.33 6 0.32 D, with 46 eyes (87%) #0.50 D and 52 eyes (98%) #1 D. Refractive astigmatism was #0.50 D in 48 eyes (90%). The efficacy index was 1.00, and the safety index was 0.98. The mean decentration from the corneal vertex was 0.28 6 0.07 mm. Conclusions:The application yielded good predictability, efficacy, and safety. Slower visual recovery was observed after extra surgical manipulations.
The purpose of this article was to evaluate the prognosis of traumatic flap dislocation or avulsion in a large series of laserassisted in situ keratomileusis (LASIK) cases.Methods: Retrospective, consecutive, noncomparative case series analyzes the visual and anatomical results after flap dislocation or avulsion, caused by trauma occurred at least 1 month after LASIK.Results: A total of 37,315 eyes of 19,602 patients were reviewed. A traumatic flap complication was observed in 9 eyes of 9 patients, with a maximum interval of 37 months after surgery. Flap dislocation with central full-thickness folds was found in 5 cases; flap lifting and repositioning achieved a full recovery of uncorrected visual acuity. In another case, a partially detached flap was repositioned by a microsponge without lifting; self-limiting localized epithelial ingrowth followed. In 3 eyes, a complete flap avulsion occurred and, after epithelialization, a moderate refractive change was observed, comprised between 20.25 and 21 diopters (D) of spherical equivalent, with astigmatism ,1 D; in 1 eye, the resulting myopia was corrected by repeat femtosecond LASIK.Conclusions: Traumatic flap complications after femtosecond LASIK are rare but can occur even in the long term; they have a favorable anatomic and visual prognosis.
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