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Friday / November 27.
HomeminewsTGA Approves Lucentis for Proliferative Diabetic Retinopathy

TGA Approves Lucentis for Proliferative Diabetic Retinopathy

The Therapeutic Goods Administration (TGA) has approved Lucentis for the treatment of proliferative diabetic retinopathy (PDR) in adults.1,2 Lucentis is the first and only pharmacological therapy available in Australia for this common, vision-threatening complication of diabetes.2

Prior to this, panretinal laser photocoagulation (PRP) has been the standard treatment for PDR for 40 years.3 However, laser therapy can result in permanent side effects, and can impact negatively on peripheral vision, thus affecting the ability to carry out daily activities, such as driving.4-6

Lucentis is the first and only pharmacological therapy available in Australia for this common, vision-threatening complication of diabetes

Diabetic retinopathy (DR) is one of the top five causes of irreversible blindness among Australian adults and the leading cause of blindness amongst working age adults worldwide.7 A common, progressive and potentially blinding complication of diabetes, DR is caused by damage to the small blood vessels of the retina and is a precursor to vision-threatening PDR.7,8 In its early stages, DR may cause no symptoms or only mild vision problems, but can worsen over time from the non-proliferative form (NPDR) to the vision-threatening form, PDR.7,8 Without treatment, approximately 50% of people with very severe NPDR progress to PDR within a year and 25% of people who have had diabetes for 15 years will have PDR.9,10

“The TGA approval of Lucentis in treating blindness in patients suffering from diabetes is welcomed by ophthalmologists. Study data shows that Lucentis is effective for improving the severity of retinopathy and treating complications due to proliferative retinopathy in addition to macular oedema”, said Clinical Associate Professor of Sydney University and Vitreoretinal Ophthalmologist and Surgeon, Dr Andrew Chang.

The regulatory approval of Lucentis was based on findings from Protocol S and supported by pooled data from the RESTORE/REVEAL/REFINE studies where Lucentis demonstrated >2 step improvement for patients on the diabetic retinopathy severity scale (DRSS) compared to laser therapy.11,12,13 Study results favoured Lucentis over laser treatment and indicated a potential to prevent PDR disease progression.13,14,15

Protocol S was a multicentre, randomised, active-controlled, parallel-assignment, non-inferiority phase 3 study in which 305 patients (394 study eyes) with PDR with or without diabetic macular oedema (DME) at baseline were enrolled. The study compared ranibizumab 0.5 mg intravitreal injections to standard treatment with PRP.11 The primary efficacy analysis was at two years, with an additional follow-up up to five years.11,12

The five-year visit was completed by 184 of 277 participants (66% excluding deaths). The mean (SD) change in visual acuity (VA) letter score was 3.1 (14.3) and 3.0 (10.5) letters, respectively (adjusted difference, 0.6; 95% CI, −2.3 to 3.5; P = .68); the mean visual acuity was 20/25 (approximate Snellen equivalent) in both groups at five years.12

The mean (SD) change in cumulative visual field total point score was −330 (645) vs −527 (635) dB in the ranibizumab (n = 41) and PRP (n = 38) groups, respectively (adjusted difference, 208 dB; 95% CI, 9−408). Vision-impairing DME developed in 27 and 53 eyes in the ranibizumab and PRP groups, respectively (cumulative probabilities: 22% vs 38%; hazard ratio, 0.4; 95% CI, 0.3-0.7).12

Despite a relatively high loss to follow-up, VA in most study eyes that completed follow-up was very good at five years and was similar in both groups. The ranibizumab group had less visual field loss and lower rates of developing vision-impairing DME. No statistically significant differences between groups in major systemic adverse event rates were identified, with findings supporting either anti-vascular endothelial growth factor therapy or PRP as viable treatments for patients with PDR.12

Very common adverse events (≥10%) observed with Lucentis were intraocular inflammation, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, foreign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocular hyperaemia, eye pruritus, intraocular pressure increased, nasopharyngitis, headache and arthralgia. Common adverse events (one to 10%) observed with Lucentis were retinal degeneration, retinal disorder, retinal detachment, retinal tear, detachment of the retinal pigment epithelium, retinal pigment epithelium tear, visual acuity reduced, vitreous haemorrhage, vitreous disorder, uveitis, iritis, iridocyclitis, cataract, cataract subcapsular, posterior capsule opacification, punctuate keratitis, corneal abrasion, anterior chamber flare, vision blurred, injection site haemorrhage, eye haemorrhage, conjunctivitis, conjunctivitis allergic, eye discharge, photopsia, photophobia, ocular discomfort, eyelid edema, eyelid pain, conjunctival hyperaemia, stroke, influenza, urinary tract infection (observed only in the DME population), anaemia, anxiety, cough, nausea and allergic reactions (rash, pruritus, urticaria, erythema).16

Ms Dee Hopkins, CEO, Macular Disease Foundation Australia (MDFA) said, “Diabetic retinopathy is the leading cause of preventable blindness in working-age Australians. MDFA welcomes the new TGA indication for Lucentis for treatment of proliferative diabetic retinopathy, which provides another option for patients and their clinicians to treat this sight-threatening condition. It is important that all patients with diabetes continue to have regular eye checks with their eye health professional in order to detect any retinopathy early. Good treatments are available to treat sight-threatening retinopathy − these help to maintain vision and prevent most cases of severe visual loss.”

Diabetes affects approximately one million Australian adults, where almost all people with type 1 diabetes and over 60% of those with type 2 diabetes will develop diabetic eye diseases within 20 years of diagnosis.7 Around one in five Australians with diabetes have diabetic retinopathy, with one in 24 over the age of 40 experiencing the proliferative form of the disease.7 As the number of individuals with diabetes is set to double by 2024, so too are the number of Australians who may be at risk of diabetic eye disease and vision loss.7

Richard Tew, Country President, Novartis Australia and New Zealand, welcomed the TGA registration, “PDR is now the sixth indication for Lucentis in Australia and is testament to Novartis’ commitment to extend the reach of this treatment for common conditions that threaten vision for millions of Australians. We are committed to working closely with all stakeholders to enable patient access to Lucentis.”

References
1. TGA: www.tga.gov.au/prescription-medicines-new-or-extended-uses-registered-medicines
2. Novartis: Lucentis Approved Product Information (PI).
3. The Diabetic Retinopathy Study Research Group. Ophthalmology. 1981;88(7):583−600.
4. Fong D et al. Retina. 2007;27(7): 816–824.
5. Subash M et al. Published online April 14, 2016. JAMA Ophthalmol. 2016;134(6):666-672. doi:10.1001/jamaophthalmol.2016.0629.
6. Mackie S et al. Eye. 1995;9:517-525.
7. Baker IDI & Centre for Eye Research Australia. Out of Sight: A report into diabetic eye disease in Australia (CERA). 2013.
8. Eshaq RS, et al. Pathophysiology. 2017;24:229–41.
9. Martinez-Zapata MJ, et al. Cochrane Database Syst Rev 2014;11:CD00872.
10. Fong DS, et al. Diabetes Care 2004;27:584–7.
11. Gross JG, et al. JAMA. 2015; 314:2137–46.
12. Gross J et al. JAMA Ophthalmol. 2018. Published online 24 July 2018. DOI:10.1001/jamaophthalmol.2018.3255.
13. Li X, et al. Graefes Arch Clin Exp Ophthalmol 2019;257:529–41.
14. Mitchell P. et al. Ophthalmology 2011;118:615–25.
15. Ishibashi T, et al. Ophthalmology 2015;112:1402–15.
16. Novartis: Lucentis Minimum Product Information

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