TIME MATTERS AND VISION MATTERS IN THIS DEVASTATING PROGRESSIVE DISEASE.

PLEASE NOTE:  PRIVATE INFORMATION WITHHELD.

"Syfovre" represents a glimmer of hope for Mum and the estimated 99,000 Australians living with dry age-related macular degeneration (AMD).

28 June 2024

Dear HPRG Executives (all names listed below)

CAMPAIGN TO EXPEDITE/FAST TRACK PRIORITY THERAPEUTIC GOODS ADMINISTRATION (TGA) APPROVAL OF "SYFOVRE" (PEGCETACOPLAN INJECTION) INTO AUSTRALIA FOR DRY MACULAR DEGENERATION (AMD).

AND NOW ONTO THE PUBLIC BENEFITS SCHEME (PBS)

As [name withheld] daughter and advocate, I am writing to you today with an urgent plea on behalf of my Mother.  Mum is currently facing a harrowing battle against age-related macular degeneration (AMD). Her condition is severe, with BOTH wet choroidal neovascularization and dry geographic atrophy ravaging her eyesight in both eyes. 

Despite undergoing intensive treatments, including 2 injections into each eye every 4 weeks, Mum's vision continues to deteriorate at an alarming rate.  The injections are "Eylea" (Anti-VEGF Treatment) a drug used to treat wet AMD and another injection to bring the eye pressure back down from 60 to 16.

As you are aware treatment for severe dry macular degeneration is not yet available in Australia. But is currently available in the USA.

In light of this dire situation, I implore the TGA to expedite the approval process for the drug "Syfovre" (Pegcetacoplan Injection) in Australia.  I cannot begin to convey the anguish this ordeal has inflicted upon my Mother.  The thought of continuing to lose her vision is profound, her independence and her quality of life is utterly devastating.  

As I was told by a macular degeneration expert "Your mother has a genetic lottery that is too sad for words".

"Syfovre" represents a glimmer of hope for Mum and the estimated 99,000 [1] Australians living with dry AMD.  Mum's ophthalmic surgeon, Dr Eric Mayer (BMBCH PHD FRCOPATH FRANZCO Vision Eye Institute Box Hill), has underscored the critical importance of this medication in assisting to preserve what still remains of her exisiting vision. Dr Eric Mayer applauds and supports our pleas for help.  I have attached a recent patient report (4/6/24) from Dr Mayer, detailing Mums rapidly deteriorating condition and the urgent need for intervention.

Furthermore, Mums unwavering commitment to advancing research in this field is evident through her participation in a year-long Macular Degeneration study "Prophylactic Laser treatment in Early Age Related macular degeneration" - under the esteemed Professor Robyn Guymer AM at Centre for Eye Research Australia. This study ended in Dec 2018.  The Laser Intervention in Age-Related Macular Degeneration" The LEAD Randomized Controlled Clinical Trial Study paper is attached as given to me by Professor Robyn Guymer.

Despite her proactive approach to managing her condition, the relentless progression of her AMD emphasizes the urgent need for access to innovative treatments like "Syfovre."

As a member of the Macular Disease Foundation Australia, Mum is acutely aware of the challenges faced by individuals living with AMD. The dry macular condition for which there is no cure.  The toll on her social life, hobbies and daily activities is profound.  Basic activities such as:  recognising faces, reading the newspaper, reading instructions, cooking, applying daily make-up, reading text messages, watching television, turning on the microwave or ordering a taxi have become acutely challenging, exacerbated by her extreme sensitivity to light contrast.

Mum is a very energetic, vital women of over 80 years old with indomitable energy.  But very sadly she is running out of time for the drug to be authorised into Australia.  Mum is personally alarmed and petrified at the rapidity in the last three months of the loss of her vision as she feels and experiences her independence slipping away together with the gradual lack of control over her own life.  It is indeed daunting to face such a lack of independence and as her daughter it is scary to watch.

Given the gravity of Mums situation and the absence of viable alternatives, I implore you to prioritize the approval process for "Syfovre". Time is running out and every day without access to this medication represents a significant setback in Mums fight to preserve her vision.

I understand the demands placed upon your office, but I urge you to consider the human aspect behind these bureaucratic processes. Mums eyesight hangs in the balance and your swift action could mean all the difference for the hope of stopping the progression of her dry eye condition.

Thank you for your prompt attention to this urgent matter. I eagerly anticipate your response and sincerely hope for a positive outcome.

With kind regards

Angela Matthews

Attachments:

1.     Dr Eric Mayer, ophthalmic surgeon - patient report 4/6/24.

2.     Carol Kilkenny, National Manager, Research and Advocacy, Macular Disease Foundation Australia Report.

3.     Professor Robyn Guymer, Centre for Eye Research Australia "Subthreshold Nanosecond Laser Intervention in Age-Related Macular Degeneration" The LEAD Randomized Controlled Clinical TrialStudy Paper.

Reference 1:  Deloitte Access Economics and Macular Degeneration Foundation (2011). Eyes on the future - A clear outlook on age-related macular degeneration.   Accessed at: www.mdfoundation.com.au/resources/eyes-on-the-future/

To HPRG Executives:

Deputy Secretary – Prof Tony Lawler
Chief Medical Adviser – Adj Prof Robyn Langham
Principal Legal and Policy Adviser – Dr Bridget Gilmour-Walsh
First Assistant Secretary, Medicines Regulation Division – Nick Henderson
First Assistant Secretary, Medical Devices and Product Quality Division – Tracey Duffy
First Assistant Secretary Regulatory Practice and Support Division – Chris Bedford