OXERVATE® Clinical Trials
The efficacy and safety of OXERVATE were established in the largest clinical trial program conducted in patients with neurotrophic keratitis4
OXERVATE study design
Two independent, double-masked, randomized, multicenter, controlled clinical trials
REPARO (NGF0212) Study (Europe, N=156*)1
All patients enrolled had moderate (stage 2) or severe (stage 3) neurotrophic keratitis.
*Phase II data only
†The formulation that was tested in REPARO (Study NGF0212) did not include the antioxidant methionine and is not the final formulation that is marketed as OXERVATE. Methionine is an excipient added to the commercial formulation to improve its stability. More than one study was conducted with the final commercial formulation. No difference in safety was seen in either of the trials.
Twenty-three vehicle-treated patients were allowed to cross over, at their physicians’ discretion, to receive 8 weeks of uncontrolled treatment of cenegermin 10 mcg/mL or cenegermin-bkbj 20 mcg/mL.
‡In the REPARO study, complete corneal healing at 8 weeks was evaluated as a prespecified secondary endpoint. Additionally, as a post-hoc efficacy analysis corneal healing was reassessed more conservatively by masked central readers and was defined as 0 mm lesion staining and no other persistent staining outside of the lesion.
OXERVATE pivotal trials included a diverse pool of neurotrophic keratitis patients
SELECT BASELINE CHARACTERISTICS FROM REPARO (NGF0212) STUDY*
OXERVATE 20 mcg/mL‡ (n=52) |
Vehicle (n=52) |
|
Primary neurotrophic keratitis diagnosis, no. (%) Stage 2 (moderate)‡ Stage 3 (severe)‡ |
27 (51.9) 25 (48.1) |
28 (53.8) 24 (46.2) |
Underlying cause, no. (%) | ||
Herpetic eye disease | 11 (21.2) | 18 (34.6) |
Neurosurgical procedure | 8 (15.3) | 7 (13.4) |
Other | 8 (15.3) | 5 (9.6) |
Dry eye disease (DED) | 6 (11.5) | 5 (9.6) |
Ocular surgery or procedure | 5 (9.6) | 7 (13.4) |
Ocular surface injury/inflammation | 5 (9.6) | 5 (9.6) |
Diabetes mellitus | 4 (7.7) | 4 (7.7) |
Stroke | 2 (3.8) | 0 |
Topical medication (glaucoma) | 1 (1.9) | 1 (1.9) |
Unknown/unspecified | 1 (1.9) | 0 |
Multifactorial | 1 (1.9) | 0 |
*Baseline characteristics were similar across all treatment arms.
†The formulation that was tested in REPARO (Study NGF0212) did not include the antioxidant methionine and is not the final formulation that is marketed as OXERVATE. Methionine is an excipient added to the commercial formulation to improve its stability. More than one study was conducted with the final commercial formulation. No difference in safety was seen in either of the trials.
‡Based on the Mackie classification
NGF0214 Study (United States, n=48)2
All patients enrolled had moderate (stage 2) or severe (stage 3) neurotrophic keratitis.
OXERVATE pivotal trials included a diverse pool of neurotrophic keratitis patients
SELECT BASELINE CHARACTERISTICS FROM NGF0214 STUDY
OXERVATE 20 mcg/mL‡ (n=24) |
Vehicle (n=24) |
|
Primary neurotrophic keratitis diagnosis, no. (%) Stage 2 (moderate)‡ Stage 3 (severe)‡ |
15 (62.5) 9 (37.5) |
18 (75.0) 6 (25.0) |
Underlying cause, no. (%) | ||
Herpetic eye disease | 9 (37.5) | 8 (33.3) |
Ocular surgery or procedure | 3 (12.5) | 4 (16.7) |
Other | 3 (12.5) | 4 (16.7) |
Dry eye disease (DED) | 3 (12.5) | 3 (12.5) |
Ocular surface injury/inflammation | 2 (8.3) | 1 (4.2) |
Multifactorial | 2 (8.3) | 0 |
Neurosurgical procedure | 1 (4.2) | 1 (4.2) |
Topical medication (glaucoma) | 1 (4.2) | 0 |
Unknown/unspecified | 0 | 2 (8.3) |
Diabetes mellitus | 0 | 1 (4.2) |
Stroke | 0 | 0 |
*Baseline characteristics were similar across all treatment arms.
‡Based on the Mackie classification
OXERVATE clinical efficacy
WITH OXERVATE, UP TO 72% OF PATIENTS ACHIEVED COMPLETE CORNEAL HEALING1,2,4
Primary efficacy analysis: complete corneal healing at 8 weeks*
Complete corneal healing was defined as 0 mm staining in the corneal lesion and no persistent staining in the rest of the cornea after 8 weeks of treatment.1,‡
*The formulation that was tested in REPARO (Study NGF0212) did not include the antioxidant methionine and is not the final formulation that is marketed as OXERVATE.
Methionine is an excipient added to the commercial formulation to improve its stability. More than one study was conducted with the final commercial formulation.
No difference in safety was seen in either of the trials.
†Last post-baseline observation carried forward; chi-squared test
‡In the REPARO study, complete corneal healing at 8 weeks was evaluated as a prespecified secondary endpoint. Additionally, as a pos-hoc efficacy analysis corneal healing
was reassessed more conservatively by masked central readers and was defined as 0 mm lesion staining and no other persistent staining outside of the lesion.
OXERVATE was generally well-tolerated in clinical trials
MOST ADVERSE EVENTS WERE LOCAL, MILD, TRANSIENT, AND DID NOT REQUIRE TREATMENT DISCONTINUATION.1
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