Efficacy of Intense Pulsed Light Treatment for Moderate to Severe Acute Blepharitis or Blepharoconjunctivitis: A Retrospective Case Series

Objectives: We aimed to evaluate the efficacy of periocular intense pulsed light (IPL) therapy in the treatment of moderate to severe acute blepharitis or blepharoconjunctivitis. Materials and Methods: This was a retrospective study performed in one institution. Eleven patients who received bilateral periocular IPL therapy using an IPL device (E>Eye, ESwin, Paris, France) were retrospectively evaluated. The following findings obtained at baseline and 10 weeks after the treatment were recorded: slit-lamp examinations; symptom scores of the Compression of the Eyelid (COTE) grading system and Ocular Surface Disease Index (OSDI); ocular surface staining with Oxford grading scale (OXFORD) scores; lipid layer thickness (LLT); and non-invasive tear meniscus test (TMH), non-invasive break up time measurement (NIBUT), and meibography performed by using I.C.P. Ocular Surface Analyzer (SBM System, Turin, Italy). Results: Significant improvements in OSDI symptom scores (p<0.0001), LLT (p<0.0001), and meibography (p<0.0001) were obtained at 10 weeks after bilateral periocular IPL therapy. COTE and ocular surface staining scores decreased by 59.72% and 57.14% respectively, while NIBUT and TMH increased by 47.34% and 22.16%, respectively. In parallel to the improvement in OSDI, LLT, and meibography, findings of acute blepharitis or blepharoconjunctivitis improved in slit-lamp examination. There were no adverse effects. Conclusion: Serial IPL therapy improves the clinical signs and symptoms of moderate to severe acute blepharitis or blepharoconjunctivitis, meibomian gland morphology, and secretion quality.

Type 1 Plasminogen Deficiency With Pulmonary Involvement: Novel Treatment and Novel Mutation.

Type 1 plasminogen deficiency is a rare genetic disorder. Type 1 plasminogen deficiency is characterized by fibrin-rich pseudomembrane formation on mucosal surfaces, particularly the conjunctiva. Tracheobronchial tree involvement is a less common reported manifestation of type 1 plasminogen deficiency. Pseudomembranes in the tracheobronchial tree may result in respiratory compromise and ultimately fail if not recognized and treated. Currently, there is no specific replacement therapy approved for the treatment of congenital plasminogen deficiency. In the present paper, we report that type 1 plasminogen deficiency with novel frameshift mutation and pulmonary involvement was treated initially with systemic fresh frozen plasma followed by pulmonary lavage with fresh frozen plasma and tissue plasminogen activator.

Comparison between two ocular cleansing modalities in a population of newborns admitted to Neonatal Intensive Care Unit with clinical signs of conjunctivitis: a randomized controlled trial.

BACKGROUND: Neonatal conjunctivitis is frequent and could benefit from daily cleansing with saline. Anyway super infections can occur and therefore antibiotics are frequently needed. Recently alternative therapies (e.g. Echinacea angustifolia) are used for neonatal conjunctivitis to try to reduce antibiotics therapy. The aim of the study was to verify if the use of gauze containing Echinacea angustifolia compared to standard sodium-chloride at the onset of conjunctivitis symptoms is effective in reducing the clinical symptoms and the risk for superinfections. METHODS: The study was randomized and controlled. Neonates admitted in a tertiary level Neonatal Intensive Care Unit (NICU), with clinical signs of conjunctivitis during hospital stay, were randomized in two groups: group A (3 times daily ocular cleansing for 48 h with sterile gauze; group B (3 times daily ocular cleansing for 48 h with Iridium® baby gauze (Neoox) containing Echinacea angustifolia and pineapple sativus). An eye swab for cultural analysis was taken at time of presentation (T0) prior to treatment and at the end of ocular cleansing (T1). RESULTS: Sixty-three neonates were enrolled (GrA=30 and GrB=33). At T0, eye specimen positivity was found in 16/30 (48%) in group A and in 18/33 (55%) in group B (P=0.9). No statistical differences among groups at T0 regarding culture positivity. After 48 h, babies in Gr A have significantly fewer positive swabs compared to group B (group A: 18/29, group B: 10/32; P=0.009). Neonates in group B who had negative swab at T0 had a significantly reduced risk to have positive culture at T1 (OR 0.28, CI: 0.10-0,80, P=0.01), also considering confounding factors (birth weight, gestational age, mode of delivery) (adjusted OR 0.15, CI: 0.03-0.52, P<0.01). No differences in regard to antibiotic needs (P=0.95) during the course of conjunctivitis between groups. CONCLUSIONS: Our data suggest that these gauzes containing Echinacea angustifolia might help in avoiding super-infections, contaminations and in reducing ocular bacterial load.

Immunologic mechanisms of a short-course of Lolium perenne peptide immunotherapy: A randomized, double-blind, placebo-controlled trial.

BACKGROUND: A 3-week short-course of adjuvant-free hydrolysates of Lolium perenne peptide (LPP) immunotherapy for rhinoconjunctivitis with or without asthma over 4 physician visits is safe, well tolerated, and effective. OBJECTIVE: We sought to investigate immunologic mechanisms of LPP immunotherapy in a subset of patients who participated in a phase III, multicenter, randomized, double-blind, placebo-controlled trial (clinical.govNCT02560948). METHODS: Participants were randomized to receive LPP (n = 21) or placebo (n = 11) for 3 weeks over 4 visits. Grass pollen-induced basophil, T-cell, and B-cell responses were evaluated before treatment (visit [V] 2), at the end of treatment (V6), and after the pollen season (V8). RESULTS: Combined symptom and rescue medication scores (CSMS) were lower during the peak pollen season (-35.1%, P = .03) and throughout the pollen season (-53.7%, P = .03) in the LPP-treated group compared with those in the placebo-treated group. Proportions of CD63+ and CD203cbrightCRTH2+ basophils were decreased following LPP treatment at V6 (10 ng/mL, P < .0001) and V8 (10 ng/mL, P < .001) compared to V2. No change in the placebo-treated group was observed. Blunting of seasonal increases in levels of grass pollen-specific IgE was observed in LPP-treated but not placebo-treated group. LPP immunotherapy, but not placebo, was associated with a reduction in proportions of IL-4+ TH2 (V6, P = .02), IL-4+ (V6, P = .003; V8, P = .004), and IL-21+ (V6, P = .003; V8, P = .002) follicular helper T cells. Induction of FoxP3+, follicular regulatory T, and IL-10+ regulatory B cells were observed at V6 (all P < .05) and V8 (all P < .05) in LPP-treated group. Induction of regulatory B cells was associated with allergen-neutralizing IgG4-blocking antibodies. CONCLUSION: For the first time, we demonstrate that the immunologic mechanisms of LPP immunotherapy are underscored by immune modulation in the T- and B-cell compartments, which is necessary for its effect.

Therapeutic Effect of Intense Pulsed Light on Ocular Demodicosis.

PURPOSE: To evaluate the clinical efficacy of Lumenis® M22TM intense pulsed light (IPL) in reduction of ocular Demodex infestation in eyelashes in a prospective study. METHODS: Forty patients with ocular demodicosis were recruited. Then half were randomly picked to receive the IPL treatment, while the other half got 5% tea tree oil (as the control group). Demodex counts, the ocular surface disease index (OSDI) score, lid margin abnormalities, conjunctival congestion, tear break-up time (TBUT), corneal staining with fluorescein, meibomian gland (MG) expressibility, meibum quality, modified Schirmer I test with anaesthetic (SIT), were assessed on the day before treatment and after treatment of 30 and 90 days, respectively. Changes in the parameters were compared between the IPL group and the control group on the days after treatment of 30 and 90 days. RESULTS: No differences were observed in Demodex counts, lid margin abnormalities, conjunctival congestion, corneal staining with fluorescein, MG expressibility, SIT in the two groups on the days after treatment of 30 and 90 days (p > 0.05), whereas there was a statistically significant difference in the OSDI score, TBUT, meibum quality (p < 0.05). The Demodex eradication rate was more thorough in the IPL group (100%) than in the control group (75%). CONCLUSIONS: IPL shows the preferably therapeutic potential for ocular Demodicosis.

[Right treatment of red eyes - prescription of topical antibiotics for infectious conjunctivitis is still common in Sweden]. / Rekommendationer följs inte vid okomplicerad konjunktivit - Tillståndet behandlas ofta med topikala antibiotika i strid mot aktuell kunskap.

Conjunctivitis is one of the most common ophthalmologic conditions in general medical practice. In most cases, it is self-limiting and do not require topical antibiotic therapy. In a retrospective, observational cohort study during 2013-2017 in a region in Sweden conjunctivitis was diagnosed in 32 000 cases in primary care. Antibiotics were prescribed in 66% of undefined and in 83% of purulent conjunctivitis. Fusidic acid was the most common medication with 81% followed by chloramphenicol with 17%. Although unnecessary, the treatment is probably harmless. Toxicity is uncommon and the cost is low. Increased consciousness of this issue may however decrease resistance to antibiotics and support evidence-based medical practice.

Evaluation of content and cost of traditional eye medication in a resource-poor country - Implications for eye care practice and policy.

BACKGROUND: Cataract, glaucoma, and conjunctivitis are common causes of ocular morbidity in Nigeria. A major obstacle in reducing the burden of ocular morbidity in rural areas is access to eye care services. Up to 80% of the population in developing countries use traditional medications for their primary healthcare needs because they are accessible, available, and affordable. The aim of this study is to evaluate the content and cost of commercialized traditional medications used in the treatment of common eye conditions in Nigeria. PATIENTS AND METHODS: All the registered traditional healers (THs) at an International Trade Fair in Enugu who treated eye problems were identified. Data on their location and scope of their practice were collected by the researchers. Proxy patients consulted THs in the trade fair with simulated cataract, glaucoma, and bacterial conjunctivitis, and treatment was sought. Medication for the treatment of the simulated disorders was paid for and procured. The mode of administration and the cost of the drugs were recorded by proxy patients. Each medication was labeled with a code and sent to the laboratories of the National Agency for Drug Administration and Control for analysis. Data were entered into a database on Microsoft Access and transferred to STATA V12.1 (StataCorp) for analysis. RESULTS: Cataract was treated by 87.5% of all the traditional eye healers interviewed. A total of 32 samples were collected and analyzed. These comprised mainly oral (53.1%) and topical traditional medications (43.8%). The pH of the topical samples ranged from 3.5 to 10, while the mean microbiological load per topical solution was 3.3 × 104 cfu/mL ± 0.96. The cost of treatment of cataract ranged from 4 to 70 USD. CONCLUSION: The content of the majority of the samples of traditional eye medications in this study had high extremes of pH and/or had a high microbial content. The practice of THs should be regulated.

Ligneous conjunctivitis due to plasminogen deficit: Diagnostic and therapeutic approach. With literature review.

Ligneous conjunctivitis is a rare and poorly understood pathology. Infections and repeated microtraumas are often involved in acute disease flare-ups. This masquerade may lead to misdiagnosis and delayed treatment. We report two cases of ligneous conjunctivitis, describing various presentations of its natural history and focusing on the treatment of this rare disease.

Treatment of Ligneous Conjunctivitis Using Topical Plasminogen Therapy in an 8-Week-Old Female Infant.

An 8-week-old female infant presented with bilateral eyelid swelling and conjunctival membranes. She was diagnosed as having ligneous conjunctivitis. The membranes were excised but recurred despite topical cyclosporine, heparin, fresh frozen plasma, and systemic fresh frozen plasma transfusions. Topical plasminogen prevented membrane recurrence and intravenous plasminogen therapy treated systemic manifestations of the disease. [J Pediatr Ophthalmol Strabismus. 2018;55:e30-e32.].

Treatment of plasminogen deficiency patients with fresh frozen plasma.

Congenital plasminogen (Plg) deficiency leads to the development of ligneous membranes on mucosal surfaces. Here, we report our experience with local and intravenous fresh frozen plasma (FFP). We retrospectively reviewed medical files of 17 patients and their eight first-degree relatives. Conjunctivitis was the main complaint. Thirteen patients were treated both with intravenous and conjunctival FFP. Venous thrombosis did not develop in any. Genetic evaluation revealed heterogeneous mutations as well as polymorphisms. Diagnosis and treatment of Plg deficiency is challenging; topical and intravenous FFP may be an alternative treatment.

Plasmapheresis, Intravenous Immunoglobulins, and Autologous Serum Eyedrops in the Acute Eye Complications of Toxic Epidermal Necrolysis.

PURPOSE: Toxic epidermal necrolysis (TEN) is a rare, life-threatening, drug-induced, mucocutaneous disease, which can severely affect the ocular surface. The purpose of this study was to investigate the efficacy of plasmapheresis, human IV immunoglobulins (IVIg), and autologous serum (AS) eyedrops in the treatment of the severe acute ocular complications of TEN. METHODS: A retrospective chart review of all patients admitted to the Burn Unit, Azienda Ospedaliero-Universitaria-Sassari, Sassari, Italy, from 2009 to 2015, identified 9 patients (2 men, 7 women; mean age 63.8 ± 24.7 years) with TEN. Bilateral, acute ocular surface complications were observed in 7 (78%) patients; 3 showed catarrhal conjunctivitis, whereas 4 had severe pseudomembranous conjunctivitis and corneal ulcers. RESULTS: All patients with TEN were immediately treated with plasmapheresis and human IVIg, which produced a marked improvement in the patients' general condition. In the 3 with catarrhal conjunctivitis, preservative-free artificial tears and topical antibiotics were beneficial. In the 4 with severe pseudomembranous conjunctivitis and corneal ulcers, treatment with AS eyedrops resulted in corneal and conjunctival epithelium healing over 3-6 weeks. After a minimum follow-up of at least 12 months, there were minimal/mild residual signs and symptoms of dry eye. CONCLUSIONS: Plasmapheresis and IVIg may be life-saving and contribute to reduce ocular surface inflammation in TEN. Autologous serum eyedrops, prepared after plasmapheresis completion and IVIg infusion, may be helpful in the management of the severe acute ocular complications of TEN.

Predictivity of clinical efficacy of sublingual immunotherapy (SLIT) based on sensitisation pattern to molecular allergens in children with allergic rhinoconjunctivitis.

BACKGROUND: The diagnostic and therapeutic approach to grass pollen allergy is now possible by detecting specific IgE (sIgE) to its allergenic components. AIM: To evaluate the correlation between the sensitisation to different molecular Phleum pratense (Phl p) allergens and clinical efficacy of SLIT. METHODS: The pilot study included 36 patients affected by allergic rhinoconjunctivitis, all treated with SLIT actively. We performed serum analysis of sIgE to Phl p 1, 2, 4, 5, 6, 7, 11 and 12. The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) and the Average Combined Score (ACS) were evaluated before and after one year of immunotherapy. RESULTS: Three different groups of sensitisation were defined based on the range of IgE reactivity to Phleum pratense allergens at baseline: group I (sIgE reactive to 1-3 allergens); group II (sIgE reactive to 4-5 allergens); and group III (sIgE reactive to 6-8 allergens). At T0 ACS was 1.79±0.18 in group I; 1.81±0.23 in group II; and 1.95±0.34 in group III. At T1 ACS was 0.85±0.55 in group I; 1.01±0.31 in group II; and 1.44±0.39 in group III. At T1 there was a significant improvement of ARTSS and ACS for group I (p=0.001). CONCLUSIONS: Sublingual immunotherapy with a grass pollen is efficacious irrespective of the patients' baseline sensitisation to either single or multiple grass pollen molecular allergens. We found that patients with few sensitisations have a greater improvement in combined symptom and medication score. SLIT improves the clinical course of allergic patients although new sensitisations may appear.

[Ocular involvement in atopic dermatitis : Clinical aspects and therapy]. / Augenbeteiligung bei atopischer Dermatitis : Klinik und Therapie.

Patients with atopic dermatitis frequently complain of ocular symptoms. The general dermatitis can directly affect the periocular skin and patients often present with chronic atopic blepharokeratoconjunctivitis. Early diagnosis of the characteristic ophthalmological alterations, such as blepharitis, allergic conjunctivitis, keratoconjunctivitis sicca, conjunctival scarring with formation of symblepharon and lid malpositioning, filiform keratitis, corneal plaques, (persistent) epithelial defects, corneal ulcers and keratoconus as well as appropriate stage-adapted treatment, including lid hygiene with preservative-free lubricants, topical and sometimes systemic anti-inflammatory therapy and surgical treatment are important for patients to prevent long-term damage of the ocular surface leading to severe visual impairment.

Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG reduces the occurrence of other allergic manifestations in children with cow's milk allergy: 3-year randomized controlled trial.

BACKGROUND: Children with cow's milk allergy (CMA) have an increased risk of other allergic manifestations (AMs). OBJECTIVE: We performed a parallel-arm randomized controlled trial to test whether administration of an extensively hydrolyzed casein formula (EHCF) containing the probiotic Lactobacillus rhamnosus GG (LGG) can reduce the occurrence of other AMs in children with CMA. METHODS: Children with IgE-mediated CMA were randomly allocated to the EHCF or EHCF+LGG groups and followed for 36 months. The main outcome was occurrence of at least 1 AM (eczema, urticaria, asthma, and rhinoconjunctivitis). The secondary outcome was tolerance acquisition, which was defined as the negativization of a double-blind food challenge results at 12, 24, and 36 months. AMs were diagnosed according to standardized criteria. Tolerance acquisition was evaluated every 12 months. RESULTS: A total of 220 children (147 boys [67%]) with a median age of 5.0 months (interquartile range, 3.0-8.0 months) were randomized; 110 children were placed in the EHCF group, and 110 children were placed in the EHCF+LGG group. In the complete case analysis the absolute risk difference for the occurrence of at least 1 AM over 36 months was -0.23 (95% CI, -0.36 to -0.10; P < .001), and the absolute risk difference for the acquisition of cow's milk tolerance was 0.20 (95% CI, 0.05-0.35; P < .01) at 12 months, 0.24 (95% CI, 0.08-0.41; P < .01) at 24 months, and 0.27 (95% CI, 0.11-0.43; P < .001) at 36 months. In the sensitivity analysis the effect size of the main outcome was virtually unchanged when the occurrence of AMs was assigned to all 27 missing children. CONCLUSIONS: EHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA.

Terapia nutricional proposta para conjuntivite lenhosa: estudo de caso e revisão de literatura / Nutritional treatment for leagnous conjuntivitis: case report and literature review and case report

RESUMO A conjuntivite lenhosa é resultante de um raro distúrbio autossômico recessivo hereditário, a deficiência de plasminogênio. Esta apresenta sintomas crônicos, como lesões conjuntivais membranosas características, inicialmente finas e com a persistência da inflamação evoluem se tornando esbranquiçadas, espessas e enrijecidas, lacrimejamento, secreção mucosa e hiperemia ocular acompanhados de espessas pseudomembranas lenhosa (PL) que recobrem a parte interior da conjuntiva tarsal. A literatura apresenta alguns tratamentos, entretanto nenhum deles alcançou a cura da doença. A terapia nutricional abordada neste estudo trata-se da combinação de nutrientes dentro dos limites estabelecidos para ingestão diária, baseada na nutrição ortomolecular, visando ao aumento da taxa de plasminogênio funcional, e a consequente redução dos sintomas associados à sua deficiência. Notou-se o desaparecimento de sintomas associados e redução do crescimento da PL, e também um aumento de 25% do plasminogênio funcional. Um aumento de 25% na dosagem de plasminogênio pode não ser altamente significativo, mas abre um respaldo para maiores estudos, pois já apresentou minimização dos sintomas da paciente.

ABSTRACT Ligneous conjunctivitis is the result of a rare inherited autosomal recessive disorder, the plasminogen deficiency. This presents chronic symptoms such as growth spongiosa meat, tearing, mucous discharge and ocular reddening accompanied by ligenous pseudomembranes (PL) coat the inside of the tarsal conjunctiva. The literature presents some treatments, but none of them reached a cure. The nutritional therapy addressed in this study is a combination of nutrients within the limits of daily intake, based on orthomolecular nutrition, aimed at increasing functional plasminogen rate, and the consequent reduction of symptoms associated with their disability. It was noted disappearance of the symptoms associated and a 25% increase in the functional plasminogen. A 25% increase in plasminogen dosage may not be highly significant, but it opens up a support for further study, as already presented reduction of symptoms of the patient.

[Clinical efficacy on xerosis conjunctivitis of liver and kidney yin deficiency treated with SHI's acupuncture manipulation].

OBJECTIVE: To compare the efficacy of the patients of xerosis conjunctivitis with liver and kidney yin deficiency among the combined therapy of acupuncture and Shi's manipulation, common acupuncture and artificial tears therapy. METHODS: One hundred and eight patients were randomized into an acupuncture group, a SHI's manipulation group and an artificial tears group, 36 cases in each group. A total of 15 cases dropped out before the end of the study, including 4 cases in the acupuncture group, 6 cases in the SHI's manipulation group, and 5 cases in the artificial tears group. In the acupuncture group, acupuncture was applied to Jingming (BL 1) and Qiuhou (EX-HN 7) on the affected side, and the bilateral Sanyinjiao (SP 6) and Taixi (KI 3). The needles were retained for 20 min. In the SHI's manipulation group, on the basis of the treatment as the acupuncture group, Shuigou (GV26) was added and stimulated with SHI's acupuncture manipulation. In these two groups, acupuncture was given 3 times a week totally for 3 weeks. In the artificial tears group, sodium hyaluronate eye drops were used, 5 times a day, for 3 weeks totally. Separately, before treatment, at the moment after the 1st treatment and 3 weeks after treatment, the subjective symptom score, Schirmer I test, breakup time (BUT) of tear film were observed in each group. RESULTS: (1) Subjective symptom score: at the moment after the 1st treatment and 3 weeks after treatment, the scores in each group were all reduced significantly as compared with those before treatment (all P < 0.05). At the moment after the 1st treatment, the score in the SHI's manipulation group and the artificial tears group was reduced apparently as compared with that in the acupuncture group (both P < 0.05). In 3 weeks of treatment, the score in the SHI's manipulation group was reduced apparently as compared with the acupuncture group and the artificial tears group (both P < 0.05). (2) For Schirmer I test, at the moment of the 1st treatment, the result in the SHI's manipulation group and the artificial tears group was improved significantly as compared with that before treatment (both P < 0.05). In 3 weeks of treatment, the result in the acupuncture group and the SHI's manipulation group group was improved significantly as compared with that before treatment (both P < 0.05). At the moment of the 1st treatment, the result in the artificial tears group was improved significantly as compared with the acupuncture group and the SHI's manipulation group (both P < 0.05). In 3 weeks of treatment, the result in the acupuncture group and the SHI's manipulation group was better than that in the artifi-cial tears group separately (both P < 0.05). (3) For BUT, the result in the acupuncture group and the SHI's manipulation group was prolonged significantly as compared with that before treatment and was prolonged apparently as compared with that in the artificial tears group (both P < 0.05) in 3 weeks of treatment. CONCLUSION: The intervention of SHI's acupuncture manipulation relieves the subjective symptoms of xerosis conjunctivitis of liver and kidney yin deficiency and achieves the same efficacy as the common acupuncture and artificial tears treatment. It does not present the apparent advantages as the common acupuncture in the short term for promoting the tear secretion and tears film repair.

New opportunities for allergen immunotherapy using synthetic peptide immuno-regulatory epitopes (SPIREs).

INTRODUCTION: Allergen immunotherapy (AIT) reduces allergic rhinoconjunctivitis (ARC) symptoms, but long-term efficacy requires treatment for 3-5 years. Synthetic peptide immuno-regulatory epitopes, a new class of AIT, are allergen peptides with a shorter, more convenient treatment regimen that could potentially have benefits on adherence and outcomes. AREAS COVERED: Phase 2 trials of therapies derived from cat, house dust mite, grass, and ragweed allergen peptides demonstrated significant reduction in ARC symptoms after short-course treatment; improvement was sustained for 18-24 months posttreatment. We conducted a PubMed literature search for clinical publications using the search terms AIT; allergen peptides; ARC; cat, grass, house dust mite, and ragweed allergy; SCIT; SLIT; and synthetic peptides. Expert commentary: Long-term disease modification is a realistic goal of AIT. The inconvenience of conventional AIT regimens negatively impacts long-term persistence and, thus, efficacy. In comparison, SPIREs have a more convenient treatment regimen that could potentially have benefits on adherence and outcomes.

Pediatric investigation plans for specific immunotherapy: Questionable contributions to childhood health.

Allergen-specific immunotherapy (SIT) is the only disease-modifying treatment for children, adolescents, and adults with allergic diseases. The EU has a combined system of national and EU-wide marketing authorization for all medicines. Germany introduced a new therapy allergen ordinance in 2008. Allergen products manufacturers had to apply for marketing authorization application for the major allergen groups (grass group, birch group, mites group, bee/wasp venom). Due to the EU pediatric regulation, in force since 2007, manufacturers had also to submit a pediatric investigation plan (PIP) for each allergen product. We investigated the allergic rhinoconjunctivitis (ARC) standard PIP, developed jointly by the European Medicines Agency (EMA) and the German Paul Ehrlich Institut (PEI). We analyzed the 118 EMA PIP decisions, looked for SIT trials in children in www.clinicaltrials.gov, and further analyzed EMA/EU justifications. The PIPs request a 1-year dose-finding study in adults, a 5-year placebo-controlled (PC) efficacy & safety (E&S) study in adults, and a 5-year PC E&S study in children. Fifty-eight PIP development programs will have to be performed until 2031. But children benefit even more from SIT for ARC than adults. There is no convincing medical/scientific justification for PC E&S studies in children in the relevant EMA documents. The PIP requirement to withhold effective treatment to thousands of children in the placebo group over a 5-year period raises profound concerns. The EMA justifications are formalistic and lack scientific foundation. A critical academic review of the ARC PIPs and the entire PIP system is urgently needed.

Successful treatment of ligneous conjunctivitis with topical fresh frozen plasma in an infant.

A 6-month-old female infant presented to our clinic with bilateral eyelid swelling, yellowish-white membranes under both lids, and mucoid ocular discharge. Her aunt had similar ocular problems that were undiagnosed. The conjunctival membranes were excised and histopathological investigation of these membranes showed ligneous conjunctivitis. Further, laboratory examination revealed plasminogen deficiency. A good response was observed to topical fresh frozen plasma (FFP) treatment without systemic therapy, and the membranes did not recur during the treatment. Topical FFP treatment may facilitate rapid rehabilitation and prevent recurrence in patients with ligneous conjunctivitis.

Successful treatment of ligneous conjunctivitis with topical fresh frozen plasma in an infant / Sucesso do tratamento da conjuntivite lenhosa com uso tópico de plasma fresco congelado em uma criança

ABSTRACTA 6-month-old female infant presented to our clinic with bilateral eyelid swelling, yellowish-white membranes under both lids, and mucoid ocular discharge. Her aunt had similar ocular problems that were undiagnosed. The conjunctival membranes were excised and histopathological investigation of these membranes showed ligneous conjunctivitis. Further, laboratory examination revealed plasminogen deficiency. A good response was observed to topical fresh frozen plasma (FFP) treatment without systemic therapy, and the membranes did not recur during the treatment. Topical FFP treatment may facilitate rapid rehabilitation and prevent recurrence in patients with ligneous conjunctivitis.

RESUMOUma criança feminina com seis meses de idade se apresentou à nossa clínica com edema palpebral bilateral, membranas brancas amareladas sob as pálpebras de ambos os olhos e descarga mucosa. Sua tia já havia apresentado problemas oculares semelhantes que não foram diagnosticados. As membranas conjuntivais foram excisadas e a investigação histopatológica das membranas demonstraram conjuntivite lenhosa. O diagnóstico de deficiência de plasminogênio foi obtido a partir de um exame laboratorial. Tratamento tópico com plasma fresco congelado (FFP) sem qualquer terapia sistêmica mostrou boa resposta. Não foram observadas recorrências das membranas. O tratamento tópico com FFP pode ajudar a reabilitação rápida e prevenir a recorrência em pacientes com conjuntivite lenhosa.