Reviewed by Bahram Bodaghi, MD, PhD
The results of LOUVRE 2, a French post-marketing, prospective and observational study, confirm the real effectiveness of the intravitreal implant of dexamethasone 0.7 mg (Ozurdex, Allergan) for the treatment of non-infectious uveitis of the posterior segment relatively long-standing.
The results also provide insight into the characteristics of patients ophthalmologists choose for treatment with the extended-release corticosteroid implant, according to Bahram Bodaghi, MD, PhD.
“Non-infectious uveitis of the posterior segment [NIPU] is the least common form of uveitis, but it is the most vision-threatening form, ”he said. “In addition to its potential to cause sudden / severe vision loss, it may be associated with painful symptoms. Due to its sequelae, NIPU can lead to a marked decrease in quality of life. “
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Bodaghi noted that in this cohort of patients seen in routine clinical practice, consisting mainly of individuals previously treated for uveitis for an average of 5 years, the intravitreal dexamethasone implant retained its functional and anatomical efficacy.
Bodaghi is professor and president of the ophthalmology department at the Sorbonne University in Paris and researcher in the LOUVRE 2 study (NCT02951975).
“In addition, the tolerability of steroid implant treatment was consistent with what has been reported in the literature,” Bodaghi said.
“With its approval in July 2010, the intravitreal dexamethasone implant became the first specialized treatment for NIPU in Europe,” he explained. “Subsequently, the prospective, multicenter and observational LOUVRE 2 study was implemented in France to assess the efficacy, safety and use of the implant in the real world in patients with NIPU.
The study recruited patients with consecutive inflammation of the posterior eye segment due to NIPU.
Twenty randomly selected injection sites participated in the study. Treatment-naïve and previously treated patients were eligible for enrollment.
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Patients who were treated with the dexamethasone implant at entry into the study may be retreated with the implant and / or alternative therapies during follow-up.
Depending on the protocol, the results would be analyzed using data from visits at months 2, 6 and 18 after patient enrollment.
A batch recall of the implant at the end of 2018 led to the study’s premature termination, and only a few patients reached the month 18 visit.
Efficacy evaluations included changes in best corrected visual acuity (BCVA) and central retinal thickness (CRT). Safety assessments reviewed AR reports.
Baseline data were available for 241 patients, 97 of whom were treated with the dexamethasone implant at the start of the study. Patients treated with dexamethasone had an average of 5 years history of NIPU and 80% had received previous treatment.
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Compared to the group of 144 patients who did not receive the implant, those treated who received the dexamethasone implant were on average 7.9 years older and had a thicker mean CRT (mean difference 91.2 µm).
In addition, the group treated with the dexamethasone implant included higher proportions of patients with cataracts (20.0% difference), macular edema (26.2% difference) and pathology associated with inflammation (8.8% difference).
Half of the patients treated with the dexamethasone implant at entry into LOUVRE 2 were not retreated at month 6, mainly because they had sufficient improvement in their disease state.
The proportion of patients treated with dexamethasone obtaining a gain greater than or equal to 15 letters in BCVA compared to the initial value was 25% at month 2 and 19.4% at month 6.
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The mean improvement from baseline BCVA was 6.2 letters at 2 months and 4.3 letters at 6 months. Central retinal dryness persisted in months 2 and 6 with mean decreases from baseline of 27.4 and 18.5 μm, respectively.
The functional gains observed are clinically relevant and were obtained despite prior treatment with the dexamethasone implant in 55.7% of patients followed prospectively.
6g “These results confirm the efficacy of the dexamethasone implant to improve visual function in patients with NIPU in the clinical setting,” said Bodaghi.
The most frequently reported AE in patients treated with the dexamethasone implant was transient ocular hypertension, occurring at a rate of 6.9%. “This finding is similar to the experience reported with the dexamethasone implant in previous prospective and retrospective studies,” Bodaghi concluded.
Bahram Bodaghi, MD, PhD
e: [email protected]
Bodaghi is a consultant for Allergan, an AbbVie company; Alimera; Horus Pharma; Novartis and Santen.