Alirocumab: Pediatric First Approval.

Alirocumab (Praluent®), a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor that has been co-developed by Regeneron Pharmaceuticals, Inc. and Sanofi (formerly sanofi-aventis), is approved globally for use in adults with established cardiovascular disease, primary hyperlipidemia [including heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH)]. In November 2023, based on clinical data in patients aged 8-17 years, alirocumab received its first pediatric approval in the EU as an adjunct to diet alone, or in combination with a statin and/or other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in pediatric patients aged ≥ 8 years with HeFH. Alirocumab was approved a few months later in the US for use as an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged ≥ 8 years with HeFH to reduce LDL-C. This article summarizes the milestones in the development of alirocumab leading to this first pediatric approval for HeFH.

Ruxolitinib Cream 1.5%: A Review in Non-Segmental Vitiligo.

Topical ruxolitinib 1.5% cream (Opzelura®), a Janus kinase (JAK) inhibitor, is the first treatment to be approved in several countries for use in patients aged ≥ 12 years with non-segmental vitiligo. In the identical phase III TRuE-V1 and TRuE-V2 trials, significantly more ruxolitinib cream recipients were able to achieve statistically significant and clinically meaningful facial and total body repigmentation, as well as reductions in vitiligo noticeability, compared with vehicle recipients. Efficacy was sustained in longer-term analyses to week 104 of treatment. Ruxolitinib 1.5% cream was generally tolerable in these trials; the most common treatment-related adverse events were acne, pruritus and exfoliation, all at the application site. As with orally administered JAK inhibitors, topical ruxolitinib carries boxed warnings in the USA for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis, although the incidences were low with topical application. Thus, topical ruxolitinib 1.5% cream is an effective and generally tolerable treatment option for patients aged ≥ 12 years with non-segmental vitiligo.

Non-segmental vitiligo is a chronic autoimmune disease where the skin throughout the body loses its pigmentation, and is usually managed with topical therapies, light therapy or surgery. Topical ruxolitinib 1.5% cream (Opzelura^®) is the first treatment approved in several countries for patients aged ≥ 12 years with non-segmental vitiligo. It inhibits Janus kinase (JAK) proteins, reducing the destruction of skin pigment-producing cells. In two clinical trials, significantly more ruxolitinib cream recipients achieved significant and meaningful skin repigmentation compared with patients who received a non-medicated cream; these results were sustained to week 104 of treatment. Ruxolitinib 1.5% cream was generally tolerable; the most common treatment-related adverse events were acne, itchiness and exfoliation, all at the application site. Topical ruxolitinib has special warnings in the USA for major adverse cardiovascular events (MACE), blood clots, serious infections, death and cancer (associated with the use of oral JAK inhibitors), although incidence rates for these adverse events were low in the clinical trials. Topical ruxolitinib 1.5% cream is an effective and generally tolerable treatment option for patients aged ≥ 12 years with non-segmental vitiligo.

Sacituzumab Govitecan: A Review in Unresectable or Metastatic HR+/HER2- Breast Cancer.

Sacituzumab govitecan (TRODELVY®) is a first-in-class trophoblast cell-surface antigen 2 (Trop-2)-directed antibody and topoisomerase I inhibitor conjugate that is approved globally as monotherapy for the treatment of adults with unresectable locally advanced or metastatic, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-; defined as immunohistochemistry 0, 1+ or 2+ and in situ hybridization-negative) breast cancer who have received endocrine-based therapy and ≥ 2 additional systemic therapies in the advanced setting. In the phase III TROPiCS-02 trial, intravenous sacituzumab govitecan demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival compared with physician's choice of chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine) in adults with metastatic HR+/HER2- breast cancer. Sacituzumab govitecan had a generally manageable tolerability profile in these patients; the most common treatment-related grade ≥ 3 adverse events included neutropenia, diarrhoea, leukopenia, anaemia, fatigue and febrile neutropenia. Sacituzumab govitecan carries regulatory warnings for severe neutropenia and severe diarrhoea. Sacituzumab govitecan demonstrated an overall benefit in terms of health-related quality of life. Current evidence indicates that sacituzumab govitecan is an effective treatment option, with a generally manageable tolerability profile, for patients with pre-treated, unresectable locally advanced or metastatic HR+/HER2- breast cancer.

The most common type of breast cancer is hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−), and management of metastatic (spread to areas near the breast or to other areas) HR+/HER2− breast cancer eventually requires chemotherapy or surgery if resistance develops. Intravenous sacituzumab govitecan (TRODELVY^®) is approved globally for adults with inoperable or metastatic HR+/HER2− breast cancer who have previously received endocrine therapy and ≥ 2 additional systemic therapies for advanced disease. In a clinical trial, sacituzumab govitecan therapy significantly improved the duration adults with metastatic HR+/HER2− breast cancer survived without their disease progressing, along with overall survival time, versus standard chemotherapy. The tolerability profile of sacituzumab govitecan was generally manageable; the most common side effects were decreased neutrophil count, diarrhoea and decreased white blood cell count. Sacituzumab govitecan can severely reduce neutrophil count and cause severe diarrhoea. Sacituzumab govitecan demonstrated an overall benefit in terms of health-related quality of life. Current evidence indicates that sacituzumab govitecan is an effective treatment option, with a generally manageable tolerability profile, for patients with pre-treated, inoperable or metastatic HR+/HER2− breast cancer.

Trastuzumab Deruxtecan: A Review in Gastric or Gastro-Oesophageal Junction Adenocarcinoma.

Trastuzumab deruxtecan (Enhertu®) is a human epidermal growth factor receptor type 2 (HER2)-directed antibody-drug conjugate that is approved in several countries globally for adults with advanced HER2-positive gastric or gastro-oesophageal junction (GOJ) adenocarcinoma who have received a prior trastuzumab-based regime. In the phase II DESTINY-Gastric01 trial, intravenous trastuzumab deruxtecan was significantly more effective than standard chemotherapy (physician's choice of intravenous irinotecan or paclitaxel) in achieving objective response and improving overall survival in Japanese or South Korean adults with advanced HER2-positive gastric or GOJ adenocarcinoma who had received two or more previous therapies. In the phase II DESTINY-Gastric02 trial, trastuzumab deruxtecan was able to induce durable response in adults from the USA or Europe with unresectable or metastatic HER2-positive gastric or GOJ adenocarcinoma. Trastuzumab deruxtecan was generally tolerable in these patients; the most common adverse events included nausea, neutropenia, fatigue and decreased appetite. Trastuzumab deruxtecan carries regulatory warnings (including boxed warnings in the USA) for interstitial lung disease/pneumonitis and embryo-foetal toxicity. Current evidence indicates that trastuzumab deruxtecan is an effective treatment option, and is generally tolerable, in previously treated adults with advanced HER2-positive gastric or GOJ adenocarcinoma.

Gastric or gastro-oesophageal junction (GOJ) adenocarcinomas are types of stomach cancer, which is one of the leading causes of cancer-related deaths globally. Some gastric cancers overexpress human epidermal growth factor receptor 2 (HER2), a predictor of relapse and poor survival. Management can involve several options, including surgery, chemotherapy, radiation and other systemic therapies as the first line of treatment. Trastuzumab plus chemotherapy is the standard treatment for patients with HER2-positive (HER2+) gastric or GOJ adenocarcinoma. Intravenously administered trastuzumab deruxtecan (Enhertu^®) is approved in several countries for adults with advanced (spread to areas near the stomach or to other parts of the body) HER2+ gastric or GOJ adenocarcinoma who have previously received a trastuzumab-based treatment. Trastuzumab deruxtecan is cytotoxic and targets HER2-expressing tumour cells. In the DESTINY-Gastric01 trial, trastuzumab deruxtecan was significantly more effective than standard chemotherapy in achieving complete or partial responses and improving overall survival in Japanese or South Korean adults with advanced gastric or GOJ adenocarcinoma. In the DESTINY-Gastric02 trial, trastuzumab deruxtecan was able to induce confirmed (4 weeks after the initial response) complete or partial responses in adults from the USA or Europe with advanced gastric or GOJ adenocarcinoma. Trastuzumab deruxtecan was generally tolerable; the most common adverse events included nausea, decreased neutrophil count, fatigue and decreased appetite. Treatment with trastuzumab deruxtecan can lead to interstitial lung disease/lung inflammation and embryo-foetal toxicity. Current evidence indicates that trastuzumab deruxtecan is an effective treatment option, and is generally tolerable, in previously treated adults with advanced HER2+ gastric or GOJ adenocarcinoma.

Retifanlimab: First Approval.

Retifanlimab (retifanlimab-dlwr; ZYNYZTM) is a programmed cell death 1 receptor-blocking antibody that is being developed by Incyte Corporation for the treatment of solid tumours, both as monotherapy and in combination with other agents. Retifanlimab recently received accelerated approval for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma. This article summarizes the milestones in the development of retifanlimab leading to this first approval for Merkel cell carcinoma.

Ravulizumab: A Review in Generalised Myasthenia Gravis.

Ravulizumab (ULTOMIRIS®) is the first long-acting complement C5 inhibitor (administered intravenously every 8 weeks) to be approved in several countries globally, for adults with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody-positive (AChR Ab+). In the phase III CHAMPION MG trial, intravenous ravulizumab was associated with statistically significant improvements in the MG-Activities of Daily Living scale at week 26 of treatment compared with placebo in adults with AChR Ab+ gMG. Improvements in the Quantitative MG scale total score were also statistically significantly higher in ravulizumab than placebo recipients. These improvements were sustained to week 26 of treatment. Ravulizumab was generally well tolerated; the most common treatment-emergent adverse events were headache, diarrhoea and nausea. Efficacy and tolerability data for up to 1 year from the ongoing open-label extension phase are consistent with those from the randomized, placebo-controlled phase; further results are awaited with interest. Thus, ravulizumab is an efficacious, generally well tolerated and convenient treatment option in adults with AChR Ab+ gMG, expanding the options available for gMG management.

Generalised myasthenia gravis (gMG) is a rare chronic condition that affects the muscles, making them become abnormally tired and weak after use. Prevalence can vary (5.3­35 per 100,000 people) and is steadily rising. Management of gMG can involve modifying or suppressing the immune system, symptom management and/or surgical removal of the thymus gland. Complement C5 inhibitors are another treatment option for patients with gMG. Ravulizumab (ULTOMIRIS^®) is the first long-acting complement C5 inhibitor (administered intravenously every 8 weeks) to be approved in several countries globally for the treatment of adults with gMG who are anti-acetylcholine receptor antibody-positive (AChR Ab+). Ravulizumab is associated with long-lasting improvements in activities of daily living and disease status in adults with AChR Ab+ gMG, as demonstrated in a phase III clinical trial. In this trial, ravulizumab was generally well tolerated; headache, diarrhoea and nausea were the most common adverse events. Although there is a potential risk for adverse reactions with ravulizumab treatment, including serious meningococcal infections, other infections and infusion-related reactions, no meningococcal infections occurred and the incidence of infusion-related reactions was low in patients with gMG. The efficacy and tolerability of ravulizumab were sustained for up to 1 year of treatment; further results are awaited with interest. Thus, ravulizumab is an efficacious, generally well tolerated and convenient treatment option in adults with AChR Ab+ gMG, expanding the options available for gMG management.

Olutasidenib: First Approval.

Olutasidenib (REZLIDHIATM), an isocitrate dehydrogenase-1 (IDH1) inhibitor, is being developed by Rigel Pharmaceuticals for the treatment of relapsed or refractory (R/R) acute myeloid leukaemia (AML). Olutasidenib was recently approved in the USA for the treatment of adults with R/R AML with a susceptible IDH1 mutation as detected by a US Food and Drug Administration-approved test. This article summarizes the milestones in the development of olutasidenib leading to this first approval for R/R AML.

Teclistamab: First Approval.

Teclistamab (TECVAYLI®), a bispecific antibody that targets CD3 and B cell maturation antigen (BCMA), is being developed by Janssen Research and Development for the treatment of relapsed or refractory multiple myeloma. Teclistamab was recently granted conditional approval in the EU for the treatment of adult patients with relapsed and refractory multiple myeloma who have received three or more prior therapies (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) and have demonstrated disease progression on the last therapy. Teclistamab was subsequently approved in the US for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody). This article summarizes the milestones in the development of teclistamab leading to this first approval for relapsed or refractory multiple myeloma.

AVT02: An Adalimumab Biosimilar.

AVT02 (Hukyndra®, Libmyris®) is a biosimilar of the reference anti-tumour necrosis factor alpha monoclonal antibody adalimumab. It is approved for use in all indications for which reference adalimumab is approved. AVT02 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and the pharmacokinetic similarity of the agent has been shown in healthy adult subjects. AVT02 demonstrated clinical efficacy similar to that of reference adalimumab in patients with chronic plaque psoriasis, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of AVT02 were similar to those of reference adalimumab. Switching from reference adalimumab to AVT02 appeared to have no impact on efficacy, safety or immunogenicity. The role of reference adalimumab in the management of immune-mediated inflammatory diseases is well established and AVT02 provides an effective biosimilar alternative for patients requiring adalimumab therapy.

Mosunetuzumab: First Approval.

Mosunetuzumab (Lunsumio®), an anti-CD20/CD3 T-cell engaging bispecific antibody, is being developed by Roche for the treatment of relapsed or refractory follicular lymphoma. Mosunetuzumab was recently conditionally approved in the EU for the treatment of relapsed or refractory follicular lymphoma in adults who have received at least two prior systemic therapies. This article summarizes the milestones in the development of mosunetuzumab leading to this first approval for relapsed or refractory follicular lymphoma.

Ofatumumab: A Review in Relapsing Forms of Multiple Sclerosis.

Ofatumumab (Kesimpta®) is a fully human anti-CD20 monoclonal antibody that can be self-administered by patients and is approved in several countries worldwide for the treatment of relapsing forms of multiple sclerosis (MS). In two identical phase III trials in adults with relapsing forms of MS, subcutaneous ofatumumab was more effective than oral teriflunomide in reducing the annualized relapse rate, as well as reducing MRI-detected lesion activity and limiting worsening of disability. Ofatumumab had a generally manageable tolerability profile; the most common adverse events (AEs) included nasopharyngitis, headache, upper respiratory tract infections and urinary tract infections. AEs of special interest (AESIs) included infections and injection-related reactions, which were generally manageable. There was no apparent association between changes in immunoglobulin G or M levels and the risk of serious infections after 3.5 years of ofatumumab treatment. Thus, ofatumumab is a convenient treatment option that is effective and has a generally manageable tolerability profile in adults with relapsing forms of MS.

MS is an incurable disease that affects ≈ 2.8 million people worldwide. Limiting the progression of disability associated with this disease is crucial, and treatments such as teriflunomide or monoclonal antibodies can prevent the relapses which define MS. Ofatumumab (Kesimpta^®), a monoclonal antibody, works by reducing the level of B cells which contribute to the development and progression of MS. Ofatumumab is approved in several countries worldwide to treat adults with certain relapsing forms of MS. It is administered by subcutaneous injection once per month and is the first therapy of its kind that patients can self-inject at home. In clinical trials, ofatumumab was more effective than teriflunomide in reducing the annual relapse rate, as well as slowing both the progression of disability and formation of new MS lesions in the brain. Ofatumumab had a generally manageable tolerability profile, although treatment resulted in infections and injection-related reactions; these were generally manageable with treatment. Thus, ofatumumab is an effective and convenient treatment option, with a generally manageable tolerability profile, in adults with relapsing forms of MS.

Moxetumomab Pasudotox in Hairy Cell Leukaemia: A Profile of Its Use.

Moxetumomab pasudotox (Lumoxiti®), an anti-CD22 recombinant immunotoxin, is an important treatment option that is approved in adults with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior lines of treatment with systemic therapies including purine nucleoside analogues. In a pivotal phase III trial, treatment with moxetumomab pasudotox resulted in approximately one third of patients achieving durable complete response lasting more than 6 months, as well as improvements in other haematological parameters and disease-related symptoms. Moxetumomab pasudotox had a generally manageable tolerability profile; the most common treatment-related adverse events (AEs) included nausea, peripheral oedema, headache and pyrexia. AEs of special interest (including haemolytic uraemic syndrome and capillary leak syndrome) were generally manageable and reversible with monitoring and supportive care.

HCL is a rare form of leukaemia (≈ 2% of all leukaemia cases) that may cause symptoms such as anaemia, easy bruising and recurrent infection due to the low production of normal blood cells. Although treatment options are available, options are limited in patients with HCL who have relapsed (disease has reappeared after remission) or are refractory (does not respond) to treatment. Moxetumomab pasudotox (Lumoxiti^®) binds to a specific protein that is overexpressed on the surface of malignant B cells, and is approved to treat adults with relapsed or refractory HCL who have been treated at least twice with systemic therapies, including a purine nucleoside analogue, for HCL. In approximately one third of patients treated with moxetumomab pasudotox, no HCL cells were found in blood or bone marrow for at least 6 months; disease-related symptoms were also improved. Moxetumomab pasudotox had a generally manageable adverse event profile. While infrequent, serious adverse events such as haemolytic uraemic syndrome and capillary leak syndrome can occur, and are generally manageable and reversible with monitoring and supportive medical care (e.g. adequate oral hydration). Thus, moxetumomab pasudotox is an important treatment option in patients with relapsed or refractory HCL who have received at least two previous treatments for HCL.

Infigratinib: First Approval.

Infigratinib (TRUSELTIQTM), a fibroblast growth factor receptor (FGFR)-specific tyrosine kinase inhibitor, is being co-developed by QED Therapeutics and Helsinn for the treatment of cholangiocarcinoma, urothelial carcinoma and other FGFR-driven conditions. Infigratinib was recently approved in the USA for the treatment of previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by a test approved by the US Food and Drug Administration. This article summarizes the milestones in the development of infigratinib leading to this first approval for advanced cholangiocarcinoma.

Luspatercept: A Review in Transfusion-Dependent Anaemia due to Myelodysplastic Syndromes or ß-Thalassaemia.

Luspatercept (Reblozyl®), a first-in-class erythroid maturation agent, is approved in several countries worldwide for the treatment of adults with transfusion-dependent anaemia due to myelodysplastic syndromes (MDS), who have failed prior erythropoiesis-stimulating therapy, or ß-thalassaemia. In pivotal, placebo-controlled, phase III trials, subcutaneous luspatercept significantly reduced red blood cell (RBC) transfusion requirements in patients with MDS or ß-thalassaemia. Luspatercept had a generally manageable tolerability profile in clinical trials. Adverse events of special interest include thromboembolic events, hypertension and bone pain. Thus, luspatercept is an emerging treatment option in adults with transfusion-dependent anaemia due to MDS or ß-thalassaemia.

Gilteritinib: A Review in Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukaemia.

Gilteritinib (Xospata®), a next-generation tyrosine kinase inhibitor (TKI), is approved in several countries/regions worldwide for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in adults with FMS-like tyrosine kinase 3 (FLT3) mutations. In this patient population, oral gilteritinib significantly improved overall survival (OS) and the response rate for complete remission with full or partial haematological recovery compared with salvage chemotherapy in the phase III ADMIRAL trial. In an integrated safety analysis of patients with relapsed or refractory AML, the most commonly reported grade ≥ 3 treatment-related adverse events (AEs) in gilteritinib recipients included anaemia, febrile neutropenia and thrombocytopenia. Clinically relevant AEs of special interest (AESIs) with gilteritinib therapy included differentiation syndrome, posterior reversible encephalopathy syndrome, QT interval prolongation and pancreatitis. AEs, including AESIs, were generally manageable with dose reduction, interruption or discontinuation. All patients of reproductive potential should use contraception during gilteritinib treatment due to the risk of embryo-foetal toxicity. Given its convenient oral regimen, along with the poor prognosis and paucity of treatment options for adults with relapsed or refractory FLT3-mutated AML, gilteritinib represents a valuable first-line targeted monotherapy in these patients.

Voretigene Neparvovec: A Review in RPE65 Mutation-Associated Inherited Retinal Dystrophy.

Voretigene neparvovec (Luxturna®), a recombinant adeno-associated virus vector-based gene therapy, delivers a functioning copy of the human retinal pigment epithelium-specific 65 kDa (RPE65) gene into retinal cells of patients with reduced or absent levels of RPE65 protein, providing the potential to restore the visual cycle. A single-dose subretinal injection of voretigene neparvovec administered in each eye is approved in several countries worldwide for the treatment of vision loss in adult and paediatric patients with confirmed biallelic RPE65 mutation-associated inherited retinal dystrophy (IRD) and with sufficient viable retinal cells. In the pivotal phase III trial, significant improvements from baseline were seen in the mean bilateral multi-luminance mobility test scores in the voretigene neparvovec group compared with the control group at 1 year. The beneficial effects of voretigene neparvovec treatment were maintained after up to 4 years of follow-up (with follow-up continuing for 15 years). Control recipients were eligible to receive voretigene neparvovec at 1 year, and showed improvements at subsequent follow-ups (≤ 3 years post injection) consistent with those in patients who received voretigene neparvovec at baseline. Most adverse reactions in voretigene neparvovec recipients were transient, asymptomatic and non-serious, and resolved without sequelae (may have been related to voretigene neparvovec, the subretinal injection procedure, concomitant corticosteroid use or a combination thereof). Retinal detachment occurred in one patient at year 4. Although ongoing additional long-term efficacy and safety data are required, voretigene neparvovec is an important novel gene therapy for patients with RPE65 mutation-associated IRD and sufficient viable retinal cells.

Atezolizumab (in Combination with Nab-Paclitaxel): A Review in Advanced Triple-Negative Breast Cancer.

Atezolizumab (Tecentriq®), an immune checkpoint inhibitor against programmed death ligand 1 (PD-L1), is the first immunotherapy agent to be approved (for use in combination with nab-paclitaxel) in the USA, the EU (as first-line) and Japan for the treatment of advanced triple-negative breast cancer (TNBC). Approval was based on the results of the phase III IMpassion130 trial in patients with unresectable locally advanced or metastatic TNBC, in which atezolizumab plus nab-paclitaxel significantly prolonged progression-free survival (PFS) when compared to placebo plus nab-paclitaxel in the intent-to-treat (ITT) population and the PD-L1+ subgroup. Statistically significant overall survival (OS) benefits were not seen in two interim analyses and final OS data are awaited. The tolerability and safety profile of atezolizumab plus nab-paclitaxel was consistent with those of each individual drug. The most common treatment-related adverse events included neutropenia, peripheral neuropathy and reduced neutrophil count. Adverse events of special interest occurred with higher frequency in patients who received atezolizumab plus nab-paclitaxel than placebo plus nab-paclitaxel, and were mostly immune-related (e.g. immune-related rash, hypothyroidism and hepatitis). Health-related quality of life was not significantly impacted by the addition of atezolizumab to nab-paclitaxel therapy. Thus, atezolizumab plus nab-paclitaxel is a useful immunochemotherapy option for patients with unresectable locally advanced or metastatic TNBC, including those whose tumours have PD-L1 expression ≥ 1%.

Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%: A Review in Post-Operative Inflammation and Pain Following Ocular Surgery.

Loteprednol etabonate ophthalmic gel 0.38% (Lotemax® SM; hereafter referred to as loteprednol etabonate gel 0.38%) is a topical ophthalmic corticosteroid approved in the USA for the treatment of post-operative inflammation and pain following ocular surgery. This formulation provides improved drug delivery compared with loteprednol etabonate micronized gel 0.5%, with a smaller drug particle size (in the submicron range) to improve dissolution and penetration into ocular tissues, meaning less loteprednol etabonate is required to exert therapeutic effect. In two multicentre, randomized phase III trials, significantly more loteprednol etabonate gel 0.38% than vehicle recipients displayed complete resolution of ocular inflammation and ocular pain at day 8 post cataract surgery. Complete resolution of pain was seen as early as post-operative day 3. Treatment-related ocular adverse events in the loteprednol etabonate gel 0.38% group occurred in < 1% of subjects and included one incidence each of photophobia, cystoid macular oedema, eyelid oedema and instillation site pain. Treatment with loteprednol etabonate gel 0.38% had no meaningful impact on intraocular pressure (IOP) or visual acuity. Thus, loteprednol etabonate gel 0.38% extends the treatment options available in resolving post-operative inflammation and pain in patients who have undergone ocular surgery.

Correction to: Trifluridine/Tipiracil: A Review in Metastatic Gastric Cancer.

The article Trifluridine/Tipiracil: A Review in Metastatic Gastric Cancer, written by Connie Kang, Sohita Dhillon and Emma D. Deeks, was originally published Online First without open access.