The safety of carbamylated monomeric allergoids for sublingual immunotherapy. Data from a pharmacovigilance study.

Aim: Sublingual immunotherapy (SLIT) is significantly less concerned by systemic reactions than subcutaneous immunotherapy. Allergoids were introduced to reduce systemic reaction to subcutaneous immunotherapy, but may also be used for SLIT. Methods: This pharmacovigilance study evaluated the post-marketing reports collected in a safety database, including the number and the type (serious or not serious) of adverse drug reactions (ADRs) in Italy by SLIT with the carbamylated monomeric allergoid (CMA). Results: More than 15,000,000 CMA tablets were administered, with 25 spontaneous reports of ADRs, only two being serious. Conclusion: The rate of ADRs to CMA we found in this pharmacovigilance survey, corresponding to 0.0004% of all administered doses, is far lower than the rates commonly reported for allergen SLIT products.

Optical pachymetry-guided custom excimer laser-assisted lamellar keratoplasty for the surgical treatment of keratoconus.

PURPOSE: To evaluate the anatomic and functional results of optical pachymetry-guided custom excimer laser-assisted lamellar keratoplasty in keratoconus patients. SETTING: Eye Clinic, University of L'Aquila, L'Aquila, Italy. DESIGN: Prospective noncomparative case series. METHODS: Patients with keratoconus having unilateral surgery using custom excimer laser-assisted lamellar keratoplasty were evaluated. A transepithelial excimer laser ablation was planned to leave an estimated uniform thickness residual stromal corneal bed of 200 µm. The donor lamella was prepared with the excimer laser and subsequently sutured to the host cornea using 16 single 10-0 nylon sutures. The eyes were examined preoperatively and 3, 6, 12, and 24 months postoperatively. Outcome measures were uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, computerized videokeratography, pachymetry, and endothelial specular microscopy. RESULTS: Of the forty-three treated eyes, 35 were available at the 24-month follow-up visit, at which time the UDVA was better than 20/60 in 16 patients (45.7%) and the CDVA was 20/40 or better in 31 patients (88.6%). The mean refractive astigmatism was -2.11 diopters (D) (P<.05) and the mean spherical equivalent manifest refraction, -2.60 D (P<.05). No statistically significant changes in mean corneal endothelial cell density were observed postoperatively. In 1 case, the donor lamella was exchanged secondary to an altered reepithelialization process with initial corneal melting. CONCLUSION: Two-year findings indicate that pachymetry-guided custom excimer laser-assisted lamellar keratoplasty is a useful surgical treatment for moderate to advanced keratoconus, preventing the need for the more invasive procedure of penetrating keratoplasty.