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AXPAXLI (axitinib intravitreal implant)

Neovascular age-related macular degeneration

Also known as OTX-TKI
Manufacturer
Ocular Therapeutix
Last updated
309 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatment

Care management intervention strategies

22 evidence topics · 19 sources

AAO Preferred Practice Pattern: dosing regimens and follow-up

“Initial treatment and follow-up with intravitreal anti-VEGF therapy should be at approximately 4-week intervals.” (opens the source at this quote in a new tab)

“There are numerous protocols: monthly or bimonthly injections, treat-and-extend, PRN, or personalized treatment interval. There is no consensus about the ideal treatment intervals with anti-VEGF agents, and the physician can tailor treatment on an individual patient basis.” (opens the source at this quote in a new tab)

AAO Preferred Practice Pattern: treat-and-extend and as-needed (PRN) regimens

“The PRN regimens using ranibizumab appear to have efficacy and safety comparable to fixed monthly regimens over 1 year of treatment, but they do not maintain the initial visual gains with longer follow-up.” (opens the source at this quote in a new tab)

“A continuous, variable dosing regimen that attempts to individualize therapy, commonly referred to as treat-and-extend, is frequently used in clinical practice as an alternative to the two treatment approaches above.” (opens the source at this quote in a new tab)

“Caution should be used when dosing PRN bevacizumab, as it may be slightly less effective than other monthly anti-VEGF regimens and other PRN anti-VEGF regimens.” (opens the source at this quote in a new tab)

As-needed dosing: CATT and IVAN regimen comparisons

“Mean gain was greater for monthly than for as-needed treatment (difference: −2.4 letters; CI: [−4.8, −0.1]; p=0.046).” (opens the source at this quote in a new tab)

“Switching from monthly to as-needed treatment resulted in greater mean decrease in vision during year 2 (−2.2 letters, p=0.03) and a lower proportion without fluid (−19%, p<0.0001).” (opens the source at this quote in a new tab)

“Discontinuous treatment was neither non-inferior nor inferior to continuous treatment (-1·63 letters, -4·01 to 0·75; p=0·18).” (opens the source at this quote in a new tab)

“Reduction in the frequency of retreatment resulted in a small loss of efficacy irrespective of drug.” (opens the source at this quote in a new tab)

Treat-and-extend: TREX-AMD 2-year results

“Sixty patients were enrolled and 50 completed month 24, at which point mean ETDRS BCVA letter gains were similar: 10.5 and 8.7 for the monthly and TREX cohorts, respectively (P = 0.64).” (opens the source at this quote in a new tab)

“Through month 24, the mean number of injections administered was 25.5 (range, 22-27) and 18.6 (range, 10-25) for the monthly and TREX cohorts, respectively (P < 0.001).” (opens the source at this quote in a new tab)

Treat-and-extend: TREX-AMD third-year results

“Transition from Monthly to PRN was associated with a decline in best corrected visual acuity (BCVA) (+10.5 letters (month 24) to +5.4 (M36, p=0.09))” (opens the source at this quote in a new tab)

“Outcomes among subjects continued on TREX were more favourable, with a mean gain of +5.0 letters at M36.” (opens the source at this quote in a new tab)

Treat-and-extend: CANTREAT 24-month results

“Participants included 580 patients with treatment-naive choroidal neovascularization secondary to AMD.” (opens the source at this quote in a new tab)

“By the end of month 24, 466 of the 580 randomized patients (80.3%) had completed the study and participants in the T&E arm received a mean of 17.6 injections compared with 23.5 injections for the monthly arm, for a difference of 5.9 injections and visits over 2 years (95% CI, 5.4-6.5; P < .001). The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, −1.6 to 3.3; P = .21).” (opens the source at this quote in a new tab)

Treat-and-extend with aflibercept: ALTAIR and ARIES

“Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2- and 4-week groups, respectively.” (opens the source at this quote in a new tab)

“Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96.” (opens the source at this quote in a new tab)

“Two-hundred seventy-one patients were randomized.” (opens the source at this quote in a new tab)

“The last injection interval (W104) was ≥12W for 47.2% and 51.9% of patients.” (opens the source at this quote in a new tab)

Treat-and-extend and loss to follow-up

“Treat-and-extend (T&E) regimens showed lower LTFU than pro re nata.” (opens the source at this quote in a new tab)

EURETINA guideline: monitoring schedules after treatment

“Patients who have received treatment should be monitored at regular intervals, according to a standardised strategy, either monthly or following an individualised pro-re-nata (PRN) or treat-and-extend regimen.” (opens the source at this quote in a new tab)

NICE guideline NG82: timely treatment and OCT monitoring

“For eyes with confirmed late AMD (wet active) for which antiangiogenic treatment is recommended (see the section on pharmacological management of AMD), offer treatment as soon as possible (within 14 days of referral to the macular service).” (opens the source at this quote in a new tab)

“Offer people with late AMD (wet active) ongoing monitoring with OCT for both eyes.” (opens the source at this quote in a new tab)

Home monitoring for fellow-eye conversion: HOME study of the ForeseeHome device

“763 participants were randomized to device monitoring and 757 to standard care, and followed for a mean of 1.4 years between July 2010-December 2013.” (opens the source at this quote in a new tab)

“The primary analysis achieved statistical significance with the participants in the device arm demonstrating a smaller decline in visual acuity with fewer letters lost from baseline to CNV detection (median (interquartile range [IQR]):−4 [−11.0, −1.0] letters) compared with standard care (median [IQR]:−9 [−14.0, −4.0] letters) (p=0.021), resulting in better visual acuity at CNV detection in the device arm.” (opens the source at this quote in a new tab)

AAO Preferred Practice Pattern: self-monitoring and electronic monitoring devices

“Electronic monitoring devices are now available to aid in the detection of neovascularization at an early stage. Such devices use hyperacuity perimetry (or vernier acuity) to create a quantified central visual map of metamorphopsia.” (opens the source at this quote in a new tab)

Home OCT self-imaging: prospective study

“The mean weekly scan frequency was 5.7 ± 0.9 scans per week, and 93% of the scans were eligible for NOA analyses. The median scan time was 42 seconds.” (opens the source at this quote in a new tab)

“The NVHO scans analyzed using NOA and the in-office OCT scans graded by human experts agreed on the fluid status in 96% of the cases.” (opens the source at this quote in a new tab)

Home OCT: FDA De Novo authorization

“Digital healthcare provider, Notal Vision, announced today that the US Food and Drug Administration (FDA) has granted De Novo authorization for its patient self-operated SCANLY® Home OCT device.” (opens the source at this quote in a new tab)

“97% of all participants were able to successfully obtain OCT images at home.” (opens the source at this quote in a new tab)

AREDS2 supplements for the fellow eye

“For patients with unilateral disease, the fellow eye without MNV remains at high risk of developing advanced AMD.” (opens the source at this quote in a new tab)

“The risk can be lowered by as much as 36% over a 10-year period by taking the AREDS/AREDS2 supplements.” (opens the source at this quote in a new tab)

AREDS2 randomized trial

“The Age-Related Eye Disease Study 2 (AREDS2), a multicenter, randomized, double-masked, placebo-controlled phase 3 study with a 2 × 2 factorial design, conducted in 2006-2012 and enrolling 4203 participants aged 50 to 85 years at risk for progression to advanced AMD with bilateral large drusen or large drusen in 1 eye and advanced AMD in the fellow eye.” (opens the source at this quote in a new tab)

“However, because of potential increased incidence of lung cancer in former smokers, lutein + zeaxanthin could be an appropriate carotenoid substitute in the AREDS formulation.” (opens the source at this quote in a new tab)

AREDS2 10-year follow-up

“The hazard ratio (HR) for progression to late AMD comparing lutein/zeaxanthin with no lutein/zeaxanthin was 0.91 (95% CI, 0.84-0.99; P = .02)” (opens the source at this quote in a new tab)

“At 10 years, the odds ratio (OR) of having lung cancer was 1.82 (95% CI, 1.06-3.12; P = .02) for those randomly assigned to beta carotene and 1.15 (95% CI, 0.79-1.66; P = .46) for lutein/zeaxanthin.” (opens the source at this quote in a new tab)

Vision rehabilitation and counseling: AAO Preferred Practice Pattern

“An important component of care for a patient with AMD is referral for vision rehabilitation as well as continued follow-up for general eye care.” (opens the source at this quote in a new tab)

“Patients should be told that these are treatments not cures for neovascular AMD and ongoing follow-up is essential to maintain the best possible vision.” (opens the source at this quote in a new tab)

“Patients who are currently smoking should be advised to stop.” (opens the source at this quote in a new tab)

Low vision rehabilitation: LOVIT randomized trial

“A total of 126 patients were included, 98% of whom were white and male.” (opens the source at this quote in a new tab)

“The difference in mean changes was 2.43 logits (95% confidence interval [CI], 2.07-2.77; P < .001; effect size, 2.51) for visual reading ability” (opens the source at this quote in a new tab)

“Because the waiting-list control patients demonstrated a decline in functional ability, low-vision services should be offered as early as possible.” (opens the source at this quote in a new tab)

Integrated low vision and mental health care: depression prevention trial

“At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27–1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27–0.98; P = 0.04).” (opens the source at this quote in a new tab)

NICE guideline NG82: support for people with visual impairment

“Be aware that people with AMD are at an increased risk of depression.” (opens the source at this quote in a new tab)

“Consider referring people with AMD causing visual impairment to low-vision services.” (opens the source at this quote in a new tab)

“Consider a group-based rehabilitation programme in addition to a low-vision service to promote independent living for people with AMD.” (opens the source at this quote in a new tab)

Conjunctival monitoring and patient education after port delivery system implantation

“Ongoing assessment of conjunctival health during follow-up visits via slit-lamp assessment is critical in monitoring for potential AEs.” (opens the source at this quote in a new tab)

“Use of fluorescein in conjunction with a cobalt blue light may aid in identifying areas of conjunctival thinning or erosion, and serial review of longitudinal clinical images of the implantation site may be helpful in identifying new clinical findings or assessing the progression of existing ones.” (opens the source at this quote in a new tab)

“In addition, patients treated with the PDS should be educated for eye hygiene and to avoid environmental exposure, which may potentially increase the risk of endophthalmitis.” (opens the source at this quote in a new tab)