Oralair (grass pollen allergen extract) / Stallergenes - LARVOL DELTA

Expanding grass pollen allergomes: benefits for the molecular profiling of products used for in vivo allergy diagnosis. (PubMed, Front Allergy) - "In-depth proteomics informed by transcriptomics enabled a major expansion of the pollen allergomes of the grass species studied. This extended allergomic knowledge, in turn, substantially improved the allergen characterization of in vivo diagnostic allergen products, confirming the added value of comprehensive grass pollen allergomes."

Journal • Preclinical • Allergy • Immunology

Impact of the definition of the standardization unit on the biological potency of grass pollen extracts (EAACI 2026) - "These differences were statistically significant to highly significant. Conclusion This study confirms, using grass pollen allergen extracts, previous findings obtained with mite and cat dander extracts, demonstrating that allergen extracts from different manufacturers with the same labelling (300 IR/mL) may in fact differ substantially in biological potency and allergen content."

Immunology

Protocol for a real-world Study to Track Response to Oralair in Naïve patients with Grass pollen allergy (STRONG) in the Netherlands (EAACI 2026) - "A total of 100-150 grass pollen allergen sublingual immunotherapy naïve patients aged 5-65 years who are prescribed 5-Grass SLIT-tablet are anticipated to be included in different hospitals and out-patient clinics across the country. Conclusion This real-world, patient-centered study will provide comprehensive insights into the perceived benefits, tolerability, and adherence of 5-Grass SLIT-tablet across different age groups in routine clinical practice in the Netherlands."

Clinical • Real-world • Real-world evidence • Allergy • Immunology

Expanding grass pollen allergomes to improve molecular characterization of diagnostic and allergen immunotherapy products (EAACI 2026) - "The expanded allergome information substantially increased the molecular resolution achieved in the characterization of diagnostic and AIT products. Conclusion Proteomics informed by transcriptomics enables a comprehensive expansion of grass pollen allergomes and provides significant added value for the molecular profiling of diagnostic and AIT products."

Allergy • Immunology

Post-marketing safety evaluation and objective benefit-risk assessment of sublingual immunotherapy tablets in allergic rhinitis. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Reports including Oralair®, Grazax®/Grastek®, Ragwitek®, and Odactra® as suspected drugs were analyzed descriptively. SLIT tablets demonstrate a favorable safety profile with a positive benefit-risk balance. They represent an effective and generally safe option for allergic rhinitis when appropriate patient selection and clinical monitoring are ensured."

Benefit-risk assessment • Journal • P4 data • Allergic Rhinitis • Dermatology • Immunology • Inflammation • Pruritus • Pulmonary Disease

Expanding Grass Pollen Allergomes: Added Value for Allergen Product Profiling (AAAAI 2026) - "The goal of this study was to broaden the known pollen allergomes of sweet vernal, orchard, perennial rye and kentucky bluegrass using a proteomics informed by transcriptomics approach with the objective to improve allergen immunotherapy (AIT) product characterization...In-depth proteomics informed by transcriptomics has supported characterization of AIT products confirming the added value of the extended grass pollen allergomes. Conclusions Proteomics informed by transcriptomics is a useful approach to deepen allergome knowledge of allergenic materials with the objective of better characterizing patient exposure and AIT products."

Sublingual immunotherapy for house dust mite allergy induces expansions of allergen-specific memory B cells expressing CD29 and downregulating IL4Rα (EAACI 2024) - "Lower levels of IL4Rα might render the cells less responsive to type 2 immune signals and contribute to the observed desensitization. In ongoing studies, the kinetics of immune memory changes, as well as the functional relevance of the immunophenotypical changes, are studied."

IO biomarker • Allergy • Immunology • FCER2 • ITGB1

300 IR 5-grass pollen sublingual immunotherapy tablet for allergic rhinoconjunctivitis: A systematic review and meta-analysis of randomised studies (EAACI 2024) - "J Clin Epidemiol. 2022; 142: 200–208."

Retrospective data • Review • Immunology

The Melbourne epidemic thunderstorm asthma event 2016: a 5-year longitudinal study. (PubMed, Asia Pac Allergy) - "Five years following sentinel event, there was progressive reduction but some persistence in asthma symptoms. Oralair allergen immunotherapy did not further improve allergic rhinitis or asthma symptoms compared to control, but there were no further ETSA events to test a protective effect during the study period."

Journal • Observational data • Allergic Rhinitis • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Update about Oralair® as a treatment for grass pollen allergic rhinitis. (PubMed, Hum Vaccin Immunother) - "Sublingual immunotherapy (SLIT) is a well-tolerated, safe, and effective approach to treating allergic rhinitis (AR). Effectiveness has been substantiated in subsequent observational studies with sustained efficacy following treatment cessation and a favorable level of adherence, quality of life, benefit, and satisfaction for the patients. Supportive evidence for a benefit in reducing the risk or delaying the development of allergic asthma is emerging."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Patient needs and benefits of sublingual immunotherapy for grass pollen-induced allergic rhinitis: an observational study. (PubMed, Immunotherapy) - "Aim: Clinical efficacy of sublingual immunotherapy for grass pollen-induced allergic rhinitis (AR) needs to translate into patient benefit. All subgroups reported relevant benefits, with significantly higher scores in some subgroups. Treatment with Oralair was associated with considerable patient-relevant benefit in all age groups."

Clinical • Journal • Observational data • Allergic Rhinitis • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Standardisation of allergen products: 4. Validation of a Candidate European Pharmacopoeia Standard Method for Quantification of Major Grass Pollen Allergen Phl p 5. (PubMed, Allergy) - "Based on the collaborative study results, the assessed Phl p 5-specific immunoassay is appropriate to be proposed as European Pharmacopoeia standard method."

Journal

Immunological Mechanisms of Oralair® in Patients With Seasonal Allergic Rhinitis (clinicaltrials.gov) - P4; N=51; Completed; Sponsor: Bayside Health; Trial primary completion date: May 2015 ➔ Nov 2019

Clinical • Trial primary completion date • Allergic Rhinitis • Immunology

Allergy immunotherapies for allergic rhinitis: systematic review and assessment of evolving quality. (PubMed, Eur Ann Allergy Clin Immunol) - "17 of 44 unique RCTs (38.6%) (sample size range: 18-1,501 subjects) were subcutaneous grass immunotherapy trials and 27 (61.4%) were sublingual grass immunotherapy trials (Allergovit, 5 trials; Alutard, 8; Grazax, 13; Oralair, 6; Staloral, 8; Pollinex, 2; Phostal and Purethal, 1 each). Conclusions. When as-sessing grass AIT, it is important to focus not only on endpoints but also on the quality of evidence."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Immunology • Respiratory Diseases

Subcutaneous immunotherapy treatment for patients with hypersensitivity to grass pollen (clinicaltrials.gov) - P3, N=150; Recruiting→Active, not recruiting

Enrollment closed • Asthma

Cost-effectiveness of grass pollen allergen immunotherapy in adults. (PubMed, Allergy) - "In daily practice AIT for grass pollens may be a cost-effective option only in patients with low discontinuation rates. SCIT, which is less affected by this limitation than SLIT, seems the most cost-effective AIT form."

Clinical • HEOR • Journal